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753 results on '"Puglisi, A."'

1. Dietary Influences on Gut Microbiota with a Focus on Metabolic Syndrome

Author

Minu S. Thomas, Christopher N. Blesso, Mariana C. Calle, Ock K. Chun, Michael Puglisi, and Maria Luz Fernandez

Subjects
Metabolic Syndrome, Dietary Fiber, Inflammation, Endocrinology, Diabetes and Metabolism, Sodium, Internal Medicine, Humans, Insulin Resistance, Sugars, Diet, High-Fat, Biomarkers, Gastrointestinal Microbiome, Diet
Abstract

There is a clear correlation between gut microbiota, diet, and metabolic outcomes. A diet high in fiber has been shown to decrease inflammation, increase insulin sensitivity, and reduce dyslipidemias whereas a diet high in fat and sugar leads to dyslipidemia, insulin resistance, and low-grade inflammation. There is recent evidence suggesting that the human gut microbiota has a significant role in the development or the resolution of metabolic syndrome (MetS) and associated conditions. Leading a stressful, sedentary lifestyle with limited or no physical activity and consuming an unhealthy diet high in saturated fat, simple carbohydrates, and sodium and low in dietary fiber and in high-quality protein are some of the contributing factors. Unhealthy diets have been shown to induce alterations in the gut microbiota and contribute to the pathogenesis of MetS by altering microbiota composition and disrupting the intestinal barrier, which leads to low-grade systemic inflammation. In contrast, healthy diets can lead to changes in microbiota that increase gut barrier function and increase the production of anti-inflammatory biomarkers. This review aims at providing a more in-depth discussion of diet-induced dysbiosis of the gut microbiota and its effect on MetS. Here, we discuss the possible mechanisms involved in the development of the metabolic biomarkers that define MetS, with an emphasis on the role of sugar and dietary fiber in microbiome-mediated changes in low-grade systemic inflammation and metabolic dysfunction.

Published
2022

2. Impact of Lung Biopsy Information on Treatment Strategy of Patients with Interstitial Lung Diseases

Author

Leonardo Gori, Sara Tomassetti, Mauro Pavone, Sara Piciucchi, Giulio Rossi, Elisabetta Rosi, Silvia Puglisi, Carlo Vancheri, Luca Donati, Valentina Luzzi, Venerino Poletti, Alessandra Dubini, AU Wells, Thomas V. Colby, Alberto Cavazza, Federico Lavorini, Jay H. Ryu, M. Matucci-Cerinic, and Claudia Ravaglia

Subjects
Pulmonary and Respiratory Medicine, Prognosis prediction, medicine.medical_specialty, High-resolution computed tomography, Biopsy, Low Confidence, Lung biopsy, surgical lung biopsy, Text mining, Usual interstitial pneumonia, Internal medicine, Bronchoscopy, medicine, Humans, interstitial lung diseases, Lung, Retrospective Studies, IPF treatment, medicine.diagnostic_test, business.industry, transbronchial lung cryobiopsy, respiratory system, idiopathic pulmonary fibrosis, medicine.disease, Idiopathic Pulmonary Fibrosis, respiratory tract diseases, medicine.anatomical_structure, Treatment strategy, Lung Diseases, Interstitial, business
Abstract

Rationale: Lung biopsy (LBx) has a relevant role in the prediction of prognosis of interstitial lung diseases (ILDs), but its impact on the clinical management of patients remains unexplored. Objectives: This study evaluates whether LBx may change the therapeutic strategy and assesses the effect of diagnostic reclassification after LBx on long-term prognosis. Methods: We evaluated the LBx of 426 consecutive patients with ILDs, without a definite usual interstitial pneumonia pattern on high-resolution computed tomographic imaging. A total of 266 patients underwent transbronchial lung cryobiopsy (TBLC), and 160 patients underwent surgical lung biopsy (SLB). The multidisciplinary team (MDT) determined a diagnosis with high or low confidence, and a management strategy, both before and after the LBx data. Results: Final MDT diagnoses were 189 idiopathic pulmonary fibrosis (IPF), 143 non-IPF fibrotic ILDs, and 94 nonfibrotic ILDs. LBx data changed the management strategy in 145 cases (34%), with similar results for TBLC and SLB (the treatment strategy changed in 31.5% of TBLC cases, 84/266, P

Published
2022

3. Durable response after immunotherapy discontinuation for delayed and severe immune-related adverse events: a case report

Author

Roberto Borea, Giuseppe Luigi Banna, Veronica Murianni, Silvia Puglisi, Fabio Catalano, Giuseppe Fornarini, Sara Elena Rebuzzi, Annalice Gandini, Francesco Trovato, Malvina Cremante, L. Cerbone, and Guido Pesola

Subjects
Adult, Male, Oncology, medicine.medical_specialty, medicine.medical_treatment, Immunology, Disease, Renal cell carcinoma, Internal medicine, medicine, Humans, Immunology and Allergy, Adverse effect, Lung cancer, Carcinoma, Renal Cell, Immune Checkpoint Inhibitors, business.industry, Melanoma, Immunotherapy, medicine.disease, Kidney Neoplasms, Discontinuation, Nivolumab, Immune System Diseases, business
Abstract

Recent studies have shown that immune-related adverse events (irAEs), occurring even after the discontinuation of immune checkpoint inhibitors (ICIs), may be associated with favorable disease outcomes, particularly in patients with melanoma and lung cancer. However, a few clinical cases have been described on the correlation between irAEs and ICIs efficacy in renal cell carcinoma (RCC) patients. This study reports the clinical case of a metastatic RCC patient who has experienced severe immune-related renal toxicity after 19 months of nivolumab use. Despite immunotherapy discontinuation, the patient has maintained clinical benefit and disease progression-free for 3 years. We examined the correlation between the occurrence and the severity of irAEs, treatment discontinuation and clinical benefits. The evidence on ICI retreatment following ICI discontinuation due to irAEs was also reviewed.Lay abstract Immunotherapy has profoundly changed the treatment scenario of cancer patients. However, similar to any oncological therapy, it may cause immune-related adverse events. Cancer patients experiencing immune-related adverse events have a higher probability of better survival outcomes. This correlation has been largely described in patients with melanoma and lung cancer, but only a few data have been reported for genitourinary tumor patients. Here, we report the clinical case of a metastatic renal cell carcinoma patient who has experienced a late-onset and severe immune-related renal toxicity after 19 months of immunotherapy, which led to treatment discontinuation. Despite this, the patient has maintained a clinical benefit and disease progression-free for more than 3.5 years. We reviewed the literature on the correlation between immunotherapy benefit and immune-related adverse events, considering the time of onset, the severity of the adverse events and the concepts of treatment discontinuation and retreatment.

Published
2021

4. L'ecografia nella diagnostica delle patologie genito-urinarie

Author

A. Granata, M. Puglisi, A. Lazzara, M. Insalaco, A. Saita, F. Logias, A. D’Amelio, L. Di Lullo, F. Marrocco, F. Floccari, and F. Fiorini

Subjects
Ecografìa, Infezioni delle vie urinarie, Cistite, Prostatite, Orchite, Internal medicine, RC31-1245, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Le infezioni delle vie urinarie costituiscono un problema clinico frequente in tutte le età. L'ecografìa è uno strumento prezioso nella diagnosi e nel management delle infezioni, consentendo di diagnosticare rapidamente complicanze e fattori predisponenti. Questa review passa in rassegna gli aspetti ecografìci delle infezioni della vescica, della prostata, delle vesci-cole seminali, dei didimi, degli epididimi e dello scroto, fornendo un pratico strumento di consultazione rapida al nefrologo.

Published
2018
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5. Leptomeningeal carcinomatosis and breast cancer: a systematic review of current evidence on diagnosis, treatment and prognosis

Author

Claudia Leli, Silvia Sardi, Ludovica Mollica, Federico Sottotetti, and Silvia Puglisi

Subjects
Oncology, medicine.medical_specialty, leptomeningeal carcinomatosis, Disease, Review, RM1-950, law.invention, Therapeutic approach, Breast cancer, breast cancer, Quality of life, Randomized controlled trial, leptomeningeal metastasis, systematic review, law, Internal medicine, medicine, Pharmacology, Performance status, business.industry, Gold standard, Cancer, General Medicine, medicine.disease, Molecular Medicine, Therapeutics. Pharmacology, business
Abstract

Leptomeningeal carcinomatosis (LC) is a rare but challenging manifestation of advanced breast cancer with a severe impact on morbidity and mortality. We performed a systematic review of the evidence published over the last two decades, focusing on recent advances in the diagnostic and therapeutic options of LC. Lobular histology and a triple-negative intrinsic subtype are well-known risk factors for LC. Clinical manifestations are diverse and often aspecific. There is no gold standard for LC diagnosis: MRI and cerebrospinal fluid cytology are the most frequently used modalities despite the low accuracy. Current standard of care involves a multimodal strategy including systemic and intrathecal chemotherapy in combination with brain radiotherapy. Intrathecal chemotherapy has been widely used through the years despite the lack of data from randomized controlled trials and conflicting evidence on patient outcomes. No specific chemotherapeutic agent has shown superiority over others for both intrathecal and systemic treatment. Although endocrine therapy was heuristically considered unable to exert significant control on central nervous system metastatic disease, retrospective data suggest a favourable toxicity profile and even a possible positive impact on survival. In recent years, encouraging data on the use of targeted agents has emerged but further research in this field is required. Palliative treatment in the form of whole brain or stereotactic radiotherapy is associated with improvement in clinical manifestations and quality of life, with no proven impact on survival. The most investigated prognostic factors include performance status, non-triple-negative disease and multimodal treatment. Validation of prognostic scores is necessary to aid clinicians in the identification of patient subgroups that are most likely to benefit from an intensive therapeutic approach.

Published
2021

6. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer

Author

Lorenzo Gerratana, Matteo Lambertini, Filippo Montemurro, Mario Giuliano, Sabino De Placido, Lucia Del Mastro, Fabio Puglisi, Luca Boni, G. Colantuoni, Teresa Gamucci, A. Turletti, Andrea Ardizzoni, Giancarlo Bisagni, Antonio Durando, Adriano Gravina, Ornella Garrone, Michelino De Laurentiis, Stefania Russo, Francesco Cognetti, Marcello Ceppi, Claudia Bighin, Puglisi F., Gerratana L., Lambertini M., Ceppi M., Boni L., Montemurro F., Russo S., Bighin C., De Laurentiis M., Giuliano M., Bisagni G., Durando A., Turletti A., Garrone O., Ardizzoni A., Gamucci T., Colantuoni G., Gravina A., De Placido S., Cognetti F., Del Mastro L., Puglisi, Fabio, Gerratana, Lorenzo, Lambertini, Matteo, Ceppi, Marcello, Boni, Luca, Montemurro, Filippo, Russo, Stefania, Bighin, Claudia, De Laurentiis, Michelino, Giuliano, Mario, Bisagni, Giancarlo, Durando, Antonio, Turletti, Anna, Garrone, Ornella, Ardizzoni, Andrea, Gamucci, Teresa, Colantuoni, Giuseppe, Gravina, Adriano, De Placido, Sabino, Cognetti, Francesco, and Del Mastro, Lucia

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Dose-dense chemotherapy, GIM2, medicine.drug_class, Article, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Internal medicine, Progesterone receptor, medicine, Pharmacology (medical), Radiology, Nuclear Medicine and imaging, RC254-282, Proportional hazards model, business.industry, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, 030104 developmental biology, Quartile, Estrogen, Hormone receptor, Outcomes research, 030220 oncology & carcinogenesis, Number needed to treat, business
Abstract

The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.

Published
2021

7. Conditioning Regimens for Frail Patients with Acute Leukemia Undergoing Allogeneic Stem Cell Transplant: How to Strike Gently

Author

Maria Vittoria Dubbini, Ilaria Scortechini, Antonio Federico Lotito, Francesco Saraceni, Francesca Romana Colaneri, Giorgia Mancini, Selene Guerzoni, Alessandro Fiorentini, Irene Federici, Attilio Olivieri, and Bruna Puglisi

Subjects
Oncology, allogeneic stem cell transplant, Acute leukemia, medicine.medical_specialty, business.industry, frail patients, Review, Review Article, Internal medicine, hemic and lymphatic diseases, medicine, Medicine, Conditioning, acute leukemia, Stem cell, business, Conditioning regimens
Abstract

Despite the recent dramatic progress in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) therapy, allogeneic transplant remains a mainstay of treatment for patients with acute leukemia. The availability of novel compounds and low intensity chemotherapy regimens made it possible for a significant proportion of elderly and comorbid patients with AML or ALL to undergo curative treatment protocols. In addition, the expansion of donor availability and the recent dramatic progress in haploidentical stem cell transplant, allow the identification of an available donor for nearly every patient. Therefore, an increasing number of transplants are currently performed in elderly and frail patients with AML or ALL. However, allo-Hematopoietic stem cell transplant (HSCT) in this delicate setting represents an important challenge, especially regarding the selection of the conditioning protocol. Ideally, conditioning intensity should be reduced as much as possible; however, in patients with acute leukemia relapse remains the major cause of transplant failure. In this article we present modern tools to assess the patient health status before transplant, review the available data on the outcome of frail AML an ALL patients undergoing allo-HSCT, and discuss how preparatory regimens can be optimized in this setting.

Published
2021

8. Gut Mesenchymal Stromal Cells in Immunity

Author

Valeria Messina, Carla Buccione, Giulia Marotta, Giovanna Ziccheddu, Michele Signore, Gianfranco Mattia, Rossella Puglisi, Benedetto Sacchetti, Livia Biancone, and Mauro Valtieri

Subjects
Internal medicine, RC31-1245
Abstract

Mesenchymal stromal cells (MSCs), first found in bone marrow (BM), are the structural architects of all organs, participating in most biological functions. MSCs possess tissue-specific signatures that allow their discrimination according to their origin and location. Among their multiple functions, MSCs closely interact with immune cells, orchestrating their activity to maintain overall homeostasis. The phenotype of tissue MSCs residing in the bowel overlaps with myofibroblasts, lining the bottom walls of intestinal crypts (pericryptal) or interspersed within intestinal submucosa (intercryptal). In Crohn’s disease, intestinal MSCs are tightly stacked in a chronic inflammatory milieu, which causes their enforced expression of Class II major histocompatibility complex (MHC). The absence of Class II MHC is a hallmark for immune-modulator and tolerogenic properties of normal MSCs and, vice versa, the expression of HLA-DR is peculiar to antigen presenting cells, that is, immune-activator cells. Interferon gamma (IFNγ) is responsible for induction of Class II MHC expression on intestinal MSCs. The reversal of myofibroblasts/MSCs from an immune-modulator to an activator phenotype in Crohn’s disease results in the formation of a fibrotic tube subverting the intestinal structure. Epithelial metaplastic areas in this context can progress to dysplasia and cancer.

Published
2017
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9. Impact of baseline and on-treatment glycemia on everolimus-exemestane efficacy in patients with hormone receptor-positive advanced breast cancer (EVERMET)

Author

Giovanna Catania, Fabio Puglisi, Dario Trapani, Federico Nichetti, Lorenzo Gerratana, Alessandra Fabi, Marika Cinausero, Michela Palleschi, Agnese Losurdo, Filippo Montemurro, Enrico Cortesi, Rebecca Pedersini, Andrea Rocca, Carlo Alberto Giorgi, Grazia Arpino, Gaia Griguolo, Lorenzo Castagnoli, Giancarlo Pruneri, Andrea Michelotti, Giuseppe Curigliano, Valentina Guarneri, Francesca Ligorio, Giovanni Randon, Daniele Generali, Emanuela Ferraro, Luca Moscetti, A. Fabbri, Arta Ajazi, Elisa Agostinetto, Claudia De Angelis, Amelia Vantaggiato, Carmen G. Rea, Antonio Marra, Filippo de Braud, Nicla La Verde, Debora Basile, Lucia Del Mastro, Luigi Mariani, Salvatore Lo Vullo, Mariangela Ciccarese, Anna Moretti, Simone Scagnoli, Claudio Vernieri, Ottavia Bernocchi, Chiara Molinelli, Andrea Milani, Luca Lalli, Vernieri, C., Nichetti, F., Lalli, L., Moscetti, L., Giorgi, C. A., Griguolo, G., Marra, A., Randon, G., Rea, C. G., Ligorio, F., Scagnoli, S., De Angelis, C., Molinelli, C., Fabbri, A., Ferraro, E., Trapani, D., Milani, A., Agostinetto, E., Bernocchi, O., Catania, G., Vantaggiato, A., Palleschi, M., Moretti, A., Basile, D., Cinausero, M., Ajazi, A., Castagnoli, L., Vullo, S. L., Gerratana, L., Puglisi, F., La Verde, N., Arpino, G., Rocca, A., Ciccarese, M., Pedersini, R., Fabi, A., Generali, D., Losurdo, A., Montemurro, F., Curigliano, G., Del Mastro, L., Michelotti, A., Cortesi, E., Guarneri, V., Pruneri, G., Mariani, L., De Braud, F., Vernieri, Claudio, Nichetti, Federico, Lalli, Luca, Moscetti, Luca, Giorgi, Carlo Alberto, Griguolo, Gaia, Marra, Antonio, Randon, Giovanni, Rea, Carmen G, Ligorio, Francesca, Scagnoli, Simone, De Angelis, Claudia, Molinelli, Chiara, Fabbri, Agnese, Ferraro, Emanuela, Trapani, Dario, Milani, Andrea, Agostinetto, Elisa, Bernocchi, Ottavia, Catania, Giovanna, Vantaggiato, Amelia, Palleschi, Michela, Moretti, Anna, Basile, Debora, Cinausero, Marika, Ajazi, Arta, Castagnoli, Lorenzo, Lo Vullo, Salvatore, Gerratana, Lorenzo, Puglisi, Fabio, La Verde, Nicla, Arpino, Grazia, Rocca, Andrea, Ciccarese, Mariangela, Pedersini, Rebecca, Fabi, Alessandra, Generali, Daniele, Losurdo, Agnese, Montemurro, Filippo, Curigliano, Giuseppe, Del Mastro, Lucia, Michelotti, Andrea, Cortesi, Enrico, Guarneri, Valentina, Pruneri, Giancarlo, Mariani, Luigi, and de Braud, Filippo

Subjects
0301 basic medicine, Oncology, Blood Glucose, Cancer Research, Receptor, ErbB-2, medicine.medical_treatment, metabolism everolimus, chemistry.chemical_compound, Phosphatidylinositol 3-Kinases, 0302 clinical medicine, ErbB-2, Exemestane, Retrospective Studie, Antineoplastic Combined Chemotherapy Protocols, Receptors, Hyperinsulinemia, drug therapy breast neoplasms, Receptors, Estrogen, Hormone receptor, 030220 oncology & carcinogenesis, Female, Breast Neoplasm, medicine.drug, Receptor, Human, medicine.medical_specialty, medicine.drug_class, Breast Neoplasms, genetics breast neoplasms, 03 medical and health sciences, Diabetes mellitus, Internal medicine, medicine, Humans, Everolimus, Retrospective Studies, Aromatase inhibitor, Antineoplastic Combined Chemotherapy Protocol, blood glucose breast neoplasms, Androstadiene, business.industry, Insulin, Cancer, medicine.disease, Estrogen, Androstadienes, 030104 developmental biology, chemistry, Phosphatidylinositol 3-Kinase, business
Abstract

Purpose: The mTOR complex C1 (mTORC1) inhibitor everolimus in combination with the aromatase inhibitor exemestane is an effective treatment for patients with hormone receptor—positive (HR+), HER2-negative (HER2−), advanced breast cancer (HR+/HER2− aBC). However, everolimus can cause hyperglycemia and hyperinsulinemia, which could reactivate the PI3K/protein kinase B (AKT)/mTORC1 pathway and induce tumor resistance to everolimus. Experimental Design: We conducted a multicenter, retrospective, Italian study to investigate the impact of baseline and on-treatment (i.e., during first 3 months of therapy) blood glucose levels on progression-free survival (PFS) in patients with HR+/HER2− aBC treated with everolimus-exemestane. Results: We evaluated 809 patients with HR+/HER2− aBC treated with everolimus-exemestane as any line of therapy for advanced disease. When evaluated as dichotomous variables, baseline and on-treatment glycemia were not significantly associated with PFS. However, when blood glucose concentration was evaluated as a continuous variable, a multivariable model accounting for clinically relevant patient- and tumor-related variables revealed that both baseline and on-treatment glycemia are associated with PFS, and this association is largely attributable to their interaction. In particular, patients who are normoglycemic at baseline and experience on-treatment diabetes have lower PFS compared with patients who are already hyperglycemic at baseline and experience diabetes during everolimus-exemestane therapy (median PFS, 6.34 vs. 10.32 months; HR, 1.76; 95% confidence interval, 1.15–2.69; P = 0.008). Conclusions: The impact of on-treatment glycemia on the efficacy of everolimus-exemestane therapy in patients with HR+/HER2− aBC depends on baseline glycemia. This study lays the foundations for investigating novel therapeutic approaches to target the glucose/insulin axis in combination with PI3K/AKT/mTORC1 inhibitors in patients with HR+/HER2− aBC.

Published
2021

10. Phyllanthus niruri and Chrysanthellum americanum in association with potassium and magnesium citrates are able to prevent symptomatic episode in patients affected by recurrent urinary stones: A prospective study

Author

Daniele Tiscione, Davide Arcaniolo, Lorenzo Ruggera, T. Tony Cai, M. Puglisi, Paolo Verze, Alessandro Palmieri, Gianni Malossini, Cai, Tommaso, Tiscione, Daniele, Puglisi, Marco, Malossini, Gianni, Ruggera, Lorenzo, Verze, Paolo, Arcaniolo, Davide, Palmieri, Alessandro, Cai, T., Tiscione, D., Puglisi, M., Malossini, G., Ruggera, L., Verze, P., Arcaniolo, D., and Palmieri, A.

Subjects
Chrysanthellum americanum, Potassium, 030232 urology & nephrology, 01 natural sciences, Gastroenterology, 0302 clinical medicine, Quality of life, Chrysanthellum, Magnesium, Citrates, Prospective Studies, Prospective cohort study, Phyllanthu, biology, medicine.diagnostic_test, Middle Aged, Asymptomatic bacteriuria, Phyllanthus niruri, Stones, Urinary Calculi, Human, Adult, medicine.medical_specialty, Phyllanthus, Urinalysis, Urology, Urinary system, chemistry.chemical_element, Citric Acid, Kidney Calculi, 03 medical and health sciences, Internal medicine, Organometallic Compounds, medicine, Humans, Organometallic Compound, business.industry, Stone, biology.organism_classification, Diseases of the genitourinary system. Urology, 0104 chemical sciences, Prospective Studie, 010404 medicinal & biomolecular chemistry, chemistry, Quality of Life, RC870-923, business, Citrate
Abstract

Objective: The aim of this study is to evaluate the efficacy of a food supplement containing Phyllanthus niruri and Chrysanthellum americanum in association with potassium and magnesium citrates in the treatment and prophylaxis of urinary stones. Materials and methods: Eighty-two patients (mean age 49.7 ± 11.2) with history of urinary stones received this food supplement, one capsule a day for 6 months. Each administration contained a combination of the following ingredients: 244 mg Potassium citrate, 735 mg Magnesium citrate, Phyllanthus (Phyllantus niruri) herb d.e. 15% mg Tannins 220 mg, Chrysanthellum (Chrysanthellum americanum Vatke) plant d.e. ¼ 55 mg. After 6 months, all patients underwent urologic visit, urinalysis, imaging and quality of life (QoL) questionnaires evaluation. Each patient was also evaluated by computed tomography (CT) scan at baseline and at 6 months. Result: From January 2018 to March 2019, 82 patients (mean age 49.7 ± 11.2) completed the follow-up period and were analyzed. Fifty patients showed lower stone dimensions (60.9%). The average stone size was 0.9 mm, with a significant reduction in comparison with the baseline (-6.7 mm ± 3 mm) (p < 0.001). Forty-nine patients (59.7%) did not show any symptomatic episode with an improving in QoL (+0.4 ± 0.1) (p < 0.001) in comparison with the baseline. At the end of the follow-up period, 27 patients out of 82 were stone-free (32.9%). Moreover, we report a significant reduction of patients with asymptomatic bacteriuria (ABU) between the baseline and the end of the follow-up evaluation (p < 0.001). Conclusions: In conclusion, this food supplement is able to improve quality of life in patients with urinary stones, reducing symptomatic episodes and the prevalence of ABU.

Published
2021

11. Endocrine‐based treatments in clinically‐relevant subgroups of hormone receptor‐positive/her2‐negative metastatic breast cancer: Systematic review and meta‐analysis

Author

Mothaffar F. Rimawi, Grazia Arpino, Angelo Di Leo, Fabiola Giudici, Pietro De Placido, Sergio Venturini, Mario Giuliano, Lajos Pusztai, Sabino De Placido, Lucia Del Mastro, Guy Jerusalem, Daniele Generali, Michelino De Laurentiis, Fabio Puglisi, Francesco Schettini, Carla Rognoni, Aleix Prat, Benedetta Conte, Rachel Schiff, Mariavittoria Locci, Pierfranco Conte, Schettini, F., Giuliano, M., Giudici, F., Conte, B., De Placido, P., Venturini, S., Rognoni, C., Leo, A. D., Locci, M., Jerusalem, G., Mastro, L. D., Puglisi, F., Conte, P., De Laurentiis, M., Pusztai, L., Rimawi, M. F., Schiff, R., Arpino, G., De Placido, S., Prat, A., Generali, D., Schettini, Francesco, Giuliano, Mario, Giudici, Fabiola, Conte, Benedetta, De Placido, Pietro, Venturini, Sergio, Rognoni, Carla, Di Leo, Angelo, Locci, Mariavittoria, Jerusalem, Guy, Del Mastro, Lucia, Puglisi, Fabio, Conte, Pierfranco, De Laurentiis, Michelino, Pusztai, Lajo, Rimawi, Mothaffar F., Schiff, Rachel, Arpino, Grazia, De Placido, Sabino, Prat, Aleix, and Generali, Daniele

Subjects
Oncology, Endocrine therapy, Cancer Research, medicine.medical_specialty, Disease, lcsh:RC254-282, meta-analysi, Meta‐analysi, Hormone receptor, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, systematic review, law, Internal medicine, medicine, Endocrine system, 030212 general & internal medicine, ENDOCRINE THERAPY, HORMONE RECEPTOR, METASTATIC BREAST CANCER, META‐ANALYSIS, SYSTEMATIC REVIEW, business.industry, endocrine therapy, Hazard ratio, hormone receptor, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Metastatic breast cancer, Meta‐analysis, Systematic review, meta-analysis, Regimen, Settore SECS-S/01 - STATISTICA, 030220 oncology & carcinogenesis, Meta-analysis, metastatic breast cancer, business, Hormone
Abstract

Simple Summary Hormone receptor-positive (HR+)/HER2-negative is the most frequent subgroup of metastatic breast cancer (MBC). Important therapeutic advances in the treatment of this tumor type have been observed in the last 20 years, with the approval of numerous endocrine therapies (ET) with or without target therapies (TT). To improve our current knowledge and support clinical decision-making, we conducted a systematic literature and meta-analysis focused on the most relevant/promising first-/second-line ET ± TT of the last 20 years. We observed that CDK4/6-inhibitors(i) + ET were the most effective regimens. At the same time, mTORi-based combinations proved to be a valid therapeutic option in endocrine-resistant tumors, as well as PI3Ki + ET in PIK3CA-mutant patients. Single agent ET might still be a valuable upfront treatment in endocrine sensitive and non-visceral disease. Abstract A precise assessment of the efficacy of first-/second-line endocrine therapies (ET) ± target therapies (TT) in clinically-relevant subgroups of hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) has not yet been conducted. To improve our current knowledge and support clinical decision-making, we thus conducted a systematic literature search to identify all first-/second-line phase II/III randomized clinical trials (RCT) of currently approved or most promising ET ± TT. Then, we performed a meta-analysis to assess progression-free (PFS) and/or overall survival (OS) benefit in several clinically-relevant prespecified subgroups. Thirty-five RCT were included (17,595 patients). Pooled results show significant reductions in the risk of relapse or death of 26–41% and 12–27%, respectively, depending on the clinical subgroup. Combination strategies proved to be more effective than single-agent ET (PFS hazard ratio (HR) range for combinations: 0.60–0.65 vs. HR range for single agent ET: 0.59–1.37; OS HR range for combinations: 0.74–0.87 vs. HR range for single agent ET: 0.68–0.98), with CDK4/6-inhibitors(i) + ET being the most effective regimen. Single agent ET showed comparable efficacy with ET+TT combinations in non-visceral (p = 0.63) and endocrine sensitive disease (p = 0.79), while mTORi-based combinations proved to be a valid therapeutic option in endocrine-resistant tumors, as well as PI3Ki + ET in PIK3CA-mutant tumors. These results strengthen international treatment guidelines and can aid therapeutic decision-making.

Published
2021

12. Abstract PD10-06: Clinical behavior and outcomes of BRCA-mutated breast cancer in young patients according to type of BRCA mutation and hormone receptor status: Results from an international cohort study

Author

Luis Augusto Teixeira, Rossella Graffeo, Luca Livraghi, Maria Vittoria Dieci, Estela Carrasco, Ann H. Partridge, Christine Rousset-Jablonski, Fabio Puglisi, Arlindo R. Ferreira, Albert Grinshpun, Matteo Lambertini, Jose Alejandro Perez-Fidalgo, Judith Balmaña, Cynthia Villarreal-Garza, Alberta Ferrari, Hatem A. Azim, Angela Toss, Shani Paluch-Shimon, Claire Senechal, Laura De Marchis, Katarzyna Pogoda, Riccardo Ponzone, Florian Clatot, Octavi Cordoba, Antonio Di Meglio, Olivier Caron, Kevin Punie, Claire Saule, Amir Sonnenblick, Philip D. Poorvu, Lucia Del Mastro, Maria Del Pilar Estevez-Diz, Marcello Ceppi, Lieveke Ameye, Anne-Sophie Hamy, Fedro A. Peccatori, Marco Bruzzone, and François Duhoux

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, BRCA mutation, Cancer, Retrospective cohort study, Disease, medicine.disease, Breast cancer, Hormone receptor, Internal medicine, Medicine, Stage (cooking), business, Cohort study
Abstract

Background: Young breast cancer patients (pts) carrying a germline BRCA mutation (mBRCA) have similar outcomes as non-carriers. However, there is currently lack of evidence regarding the impact of mBRCA type and hormone receptor status on clinical behavior and outcomes of mBRCA breast cancer. We aim to address these questions in the largest dataset to date of young mBRCA breast cancer pts. Methods: This was an international, multicenter, hospital-based, retrospective cohort study. Women harboring deleterious germline mBRCA1 or mBRCA2 that received a diagnosis of stage I-III invasive early breast cancer at age ≤40 years between January 2000 and December 2012 were included. Baseline pts, tumor, and treatment characteristics, pattern and risk over time of disease-free survival (DFS) events, and survival outcomes (DFS, distant recurrence-free interval [DRFI] and overall survival [OS]) were compared between mBRCA1 and mBRCA2 pts overall and by hormone receptor status. Multivariate Cox proportional hazard models were used to compare hazard rates (HRs). Results: 1,236 young mBRCA breast cancer pts were included. Among 808 and 428 pts with mBRCA1 or mBRCA2, respectively, 191 (23.6%) and 356 (83.2%) had hormone receptor-positive tumors while 617 (76.4%) and 72 (16.8%) hormone receptor-negative disease (p Conclusions: In this large unique dataset, young mBRCA1 breast cancer pts had worse DFS than those with mBRCA2 mostly due to higher rates of second primary malignancies. Hormone receptor positivity had no positive prognostic value in young mBRCA breast cancer pts with a trend towards worse DRFI in those with hormone receptor-negative disease. These results provide important information for counseling young mBRCA breast cancer pts regarding treatment, prevention and follow-up care strategies. Citation Format: Matteo Lambertini, Marcello Ceppi, Anne-Sophie Hamy, Olivier Caron, Philip D. Poorvu, Estela Carrasco, Albert Grinshpun, Kevin Punie, Christine Rousset-Jablonski, Alberta Ferrari, Shani Paluch-Shimon, Angela Toss, Claire Senechal, Fabio Puglisi, Katarzyna Pogoda, Jose Alejandro Pérez-Fidalgo, Laura De Marchis, Riccardo Ponzone, Luca Livraghi, Maria Del Pilar Estevez-Diz, Cynthia Villarreal-Garza, Maria Vittoria Dieci, Florian Clatot, Francois P. Duhoux, Rossella Graffeo, Luis Teixeira, Octavi Córdoba, Amir Sonnenblick, Arlindo R. Ferreira, Ann H. Partridge, Antonio Di Meglio, Claire Saule, Fedro A. Peccatori, Marco Bruzzone, Lucia Del Mastro, Lieveke Ameye, Judith Balmaña, Hatem A. Azim, Jr. Clinical behavior and outcomes of BRCA-mutated breast cancer in young patients according to type of BRCA mutation and hormone receptor status: Results from an international cohort study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD10-06.

Published
2021

13. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion : an international, retrospective, cohort study

Author

Timo Deutschbein, Giuseppe Reimondo, Guido Di Dalmazi, Irina Bancos, Jekaterina Patrova, Dimitra Argyro Vassiliadi, Anja Barač Nekić, Miguel Debono, Pina Lardo, Filippo Ceccato, Luigi Petramala, Alessandro Prete, Iacopo Chiodini, Miomira Ivović, Kalliopi Pazaitou-Panayiotou, Krystallenia I Alexandraki, Felicia Alexandra Hanzu, Paola Loli, Serkan Yener, Katharina Langton, Ariadni Spyroglou, Tomaz Kocjan, Sabina Zacharieva, Nuria Valdés, Urszula Ambroziak, Mari Suzuki, Mario Detomas, Soraya Puglisi, Lorenzo Tucci, Danae Anastasia Delivanis, Dimitris Margaritopoulos, Tina Dusek, Roberta Maggio, Carla Scaroni, Antonio Concistrè, Cristina Lucia Ronchi, Barbara Altieri, Cristina Mosconi, Aristidis Diamantopoulos, Nicole Marie Iñiguez-Ariza, Valentina Vicennati, Anna Pia, Matthias Kroiss, Gregory Kaltsas, Alexandra Chrisoulidou, Ljiljana V Marina, Valentina Morelli, Wiebke Arlt, Claudio Letizia, Marco Boscaro, Antonio Stigliano, Darko Kastelan, Stylianos Tsagarakis, Shobana Athimulam, Uberto Pagotto, Uwe Maeder, Henrik Falhammar, John Newell-Price, Massimo Terzolo, and Martin Fassnacht

Subjects
Sex Characteristics, hypertension, Endocrinology, Diabetes and Metabolism, Sexual Behavior, dexamethasone, Article, retrospective studies, Endocrinology, female, cohort studies, male, middle aged, adrenal gland neoplasms, Internal Medicine, adenoma, hydrocortisone, humans
Abstract

Background\ud \ud The association between cortisol secretion and mortality in patients with adrenal incidentalomas is controversial. We aimed to assess all-cause mortality, prevalence of comorbidities, and occurrence of cardiovascular events in uniformly stratified patients with adrenal incidentalomas and cortisol autonomy (defined as non-suppressible serum cortisol on dexamethasone suppression testing).\ud \ud \ud \ud Methods\ud \ud We conducted an international, retrospective, cohort study (NAPACA Outcome) at 30 centres in 16 countries. Eligible patients were aged 18 years or older with an adrenal incidentaloma (diameter ≥1 cm) detected between Jan 1, 1996, and Dec 31, 2015, and availability of a 1 mg dexamethasone suppression test result from the time of the initial diagnosis. Patients with clinically apparent hormone excess, active malignancy, or follow-up of less than 36 months were excluded. Patients were stratified according to the 0800–0900 h serum cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L was classed as non-functioning adenoma, 50–138 nmol/L as possible autonomous cortisol secretion, and greater than 138 nmol/L as autonomous cortisol secretion. The primary endpoint was all-cause mortality. Secondary endpoints were the prevalence of cardiometabolic comorbidities, cardiovascular events, and cause-specific mortality. The primary and secondary endpoints were assessed in all study participants.\ud \ud \ud \ud Findings\ud \ud Of 4374 potentially eligible patients, 3656 (2089 [57·1%] with non-functioning adenoma, 1320 [36·1%] with possible autonomous cortisol secretion, and 247 [6·8%] with autonomous cortisol secretion) were included in the study cohort for mortality analysis (2350 [64·3%] women and 1306 [35·7%] men; median age 61 years [IQR 53–68]; median follow-up 7·0 years [IQR 4·7–10·2]). During follow-up, 352 (9·6%) patients died. All-cause mortality (adjusted for age, sex, comorbidities, and previous cardiovascular events) was significantly increased in patients with possible autonomous cortisol secretion (HR 1·52, 95% CI 1·19–1·94) and autonomous cortisol secretion (1·77, 1·20–2·62) compared with patients with non-functioning adenoma. In women younger than 65 years, autonomous cortisol secretion was associated with higher all-cause mortality than non-functioning adenoma (HR 4·39, 95% CI 1·93–9·96), although this was not observed in men. Cardiometabolic comorbidities were significantly less frequent with non-functioning adenoma than with possible autonomous cortisol secretion and autonomous cortisol secretion (hypertension occurred in 1186 [58·6%] of 2024 patients with non-functioning adenoma, 944 [74·0%] of 1275 with possible autonomous cortisol secretion, and 179 [75·2%] of 238 with autonomous cortisol secretion; dyslipidaemia occurred in 724 [36·2%] of 1999 patients, 547 [43·8%] of 1250, and 123 [51·9%] of 237; and any diabetes occurred in 365 [18·2%] of 2002, 288 [23·0%] of 1250, and 62 [26·7%] of 232; all p values

Published
2022

14. Mitotane Concentrations Influence Outcome in Patients With Advanced Adrenocortical Carcinoma

Author

Carla Scaroni, Silvia Della Casa, Soraya Puglisi, Massimo Torlontano, Marco Russo, Paola Berchialla, Alessandra Quirino, Paola Perotti, Barbara Altieri, Anna Calabrese, Antonio Stigliano, Maria Cristina De Martino, Francesco Ferraù, Filippo Ceccato, Giuseppe Badalamenti, Rosario Pivonello, Giorgio Arnaldi, Paola Loli, Letizia Canu, Vittoria Basile, Laura Saba, Massimo Terzolo, Puglisi S., Calabrese A., Basile V., Ceccato F., Scaroni C., Altieri B., Casa S.D., Loli P., Pivonello R., De Martino M.C., Canu L., Russo M., Badalamenti G., Torlontano M., Stigliano A., Ferrau F., Arnaldi G., Saba L., Quirino A., Perotti P., Berchialla P., Terzolo M., Puglisi, S., Calabrese, A., Basile, V., Ceccato, F., Scaroni, C., Altieri, B., Casa, S. D., Loli, P., Pivonello, R., De Martino, M. C., Canu, L., Russo, M., Badalamenti, G., Torlontano, M., Stigliano, A., Ferrau, F., Arnaldi, G., Saba, L., Quirino, A., Perotti, P., Berchialla, P., and Terzolo, M.

Subjects
Oncology, mitotane, Cancer Research, medicine.medical_specialty, Multivariate analysis, recurrence, Combination therapy, Prognosi, medicine.medical_treatment, 030209 endocrinology & metabolism, Disease, lcsh:RC254-282, behavioral disciplines and activities, survival, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Adrenocortical carcinoma, Mitotane, In patient, adrenal cancer, Objective response, prognosis, Chemotherapy, business.industry, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, 030220 oncology & carcinogenesis, business, Adrenal cancer, Mitotane, Prognosis, Recurrence, Survival, medicine.drug
Abstract

Mitotane is the main option of treatment for advanced adrenocortical carcinoma (ACC). However, limited evidence is available regarding the impact of plasma mitotane levels on patient outcome. To address this question, we retrospectively analyzed patients with advanced ACC treated with mitotane for &ge, 3 months, with &ge, 3 measurements of plasma mitotane reported in the Lysosafe Online&reg, database (HRA Pharma, France), followed at 12 tertiary centers in Italy from 2005 to 2017. We identified 80 patients, initially treated with mitotane alone (56.2%) or plus chemotherapy (43.8%). The preference toward combination therapy was given to de novo stage IV ACC and younger patients. After the first line of treatment, 25% of valid cases experienced clinical benefit (14.5% objective response, 10.5% stabilization of disease) and 75% progression, without differences between the groups of treatment. Patients with progression had a lower time in the target range (TTR) of plasma mitotane and an unfavorable outcome. Death occurred in 76.2% of cases and multivariate analysis showed that clinical benefit after first treatment and longer TTR were favorable predictors of overall survival (OS). In conclusion, the present findings support the importance of mitotane monitoring and strengthen the concept of a therapeutic window for mitotane.

Published
2020

15. What factors have impact on glucocorticoid replacement in adrenal insufficiency: a real-life study

Author

Massimo Terzolo, Giuseppe Reimondo, A. Rossini, Francesco Ferraù, S. Cannavò, Anna Pia, Marta Ragonese, Soraya Puglisi, Giorgio Borretta, A. Latina, A. Parisi, Isabella Tabaro, Micaela Pellegrino, and Francesca Dughera

Subjects
Male, medicine.medical_specialty, Hydrocortisone, Hormone Replacement Therapy, Endocrinology, Diabetes and Metabolism, Fludrocortisone, 030209 endocrinology & metabolism, Gastroenterology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Sex Factors, Internal medicine, Hypoadrenalism, medicine, Adrenal insufficiency, Humans, Drug Dosage Calculations, Dosing, Addison, Management, Glucocorticoids, Retrospective Studies, Dose-Response Relationship, Drug, business.industry, Body Weight, Middle Aged, medicine.disease, Patient Care Management, Cortisone, Addison, Fludrocortisone, Hydrocortisone, Hypoadrenalism, Management, Italy, 030220 oncology & carcinogenesis, Etiology, Original Article, Female, Risk Adjustment, business, Life study, Glucocorticoid, medicine.drug, Adrenal Insufficiency, Follow-Up Studies
Abstract

Purpose The impact of patient’s characteristics on glucocorticoid (GC) replacement therapy in adrenal insufficiency (AI) is poorly evaluated. Aims of this study were to assess the influence of sex and body weight on GC dosing and to describe the choice of GC in AI of different etiologies. Methods We retrospectively evaluated hydrocortisone (HC) equivalent total daily dose (HC-TDD) and per-kg-daily dose (HC-KDD) in 203 patients (104 primary AI [pAI], 99 secondary AI [sAI]) followed up for ≥ 12 months. They were treated with HC, modified-release HC (MRHC) or cortisone acetate (CA) and fludrocortisone acetate (FCA) in pAI. Results At baseline, CA was preferred both in pAI and sAI; at last visit, MRHC was most used in pAI (49%) and CA in sAI (73.7%). Comparing the last visit with baseline, in pAI, HC-TDD and HC-KDD were significantly lower (p = 0.04 and p = 0.006, respectively), while FCA doses increased during follow-up (p = 0.02). The reduction of HC-TDD and HC-KDD was particularly relevant for pAI women (p = 0.04 and p = 0.002, respectively). In sAI patients, no change of HC-KDD and HC-TDD was observed, and we found a correlation between weight and HC-TDD in males (r 0.35, p = 0.02). Conclusions Our real-life study demonstrated the influence of etiology of AI on the type of GC used, a weight-based tailoring in sAI, a likely overdosage of GC treatment in pAI women at the start of treatment and the possibility to successfully increase FCA avoiding GC over-treatment. These observations could inform the usual clinical practice.

Published
2020

16. Platinum-Based Chemotherapy in Older Patients with Non-Small Cell Lung Cancer: What to Expect in the Real World

Author

M. Giavarra, Marianna Macerelli, M. Cattaneo, Alessandro Follador, Giacomo Pelizzari, C. Lisanti, Michele Bartoletti, Vanessa Buoro, Gianpiero Fasola, Simona Rizzato, Fabio Puglisi, Ciro Rossetto, and F. Cortiula

Subjects
Male, medicine.medical_specialty, Lung Neoplasms, Carboplatin, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Maintenance therapy, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Pharmacology (medical), 030212 general & internal medicine, Medical prescription, Lung cancer, Aged, Neoplasm Staging, Retrospective Studies, business.industry, Hazard ratio, Odds ratio, Middle Aged, medicine.disease, Progression-Free Survival, Confidence interval, Italy, Cohort, Female, Cisplatin, Geriatrics and Gerontology, business, 030217 neurology & neurosurgery
Abstract

The role of platinum-based chemotherapy (PBC) for the treatment of older patients with non-small cell lung cancer (NSCLC) is still a matter of debate, despite the advent of immunotherapy. The aim of the study was to identify factors associated with first-line PBC prescription and, secondly, to evaluate the impact of first-line PBC on survival, treatment intensity, risk of hospitalization, and subsequent treatments. We reviewed a consecutive series of 474 older patients (age ≥ 70 years) diagnosed with stage IIIB–IV NSCLC at the Department of Oncology, University Hospital of Udine, Italy from January 2009 to March 2017. Overall, 198 patients were deemed eligible, and 65.2% received a PBC. At multivariate analysis, older age was the only factor associated with PBC prescription. In the whole cohort, 46 patients (23.2%) were hospitalized for chemotherapy-related toxicity. Both PBC prescription (odds ratio [OR] 2.23, 95% confidence interval [CI] 1.02–4.87, p = 0.04) and tumor burden (OR 2.39, 95% CI 1.07–5.32, p = 0.03) emerged as independent risk factors for hospitalization. Moving to significant predictors of patterns of care, Eastern Cooperative Oncology Group (ECOG) performance status > 0 was associated with greater risk of first-line failure (OR 2.20, 95% CI 1.15–4.20, p = 0.02), while bone metastases (OR 0.29, 95% CI 0.12–0.69, p = 0.005) and a Charlson Comorbidity Index score ≥ 3 (OR 0.40, 95% CI 0.19–0.84, p = 0.016) independently predicted lower probability of receiving second-line therapy. Remarkably, PBC did not significantly impact overall survival (hazard ratio [HR] 0.83, 95% CI 0.61–1.14, p = 0.24) and progression-free survival (HR 0.95, 95% CI 0.70–1.28, p = 0.73) compared to single-agent chemotherapy (SAC). However, according to an exploratory landmark analysis, patients who received four cycles of treatment or maintenance therapy experienced prolonged overall survival, regardless of PBC use. This study evaluated the real-world use of PBC in older patients with NSCLC, offering an insight into the determinants of its prescription and the pattern of care of these patients. Of note, PBC use was associated with a higher likelihood of hospitalization for chemotherapy-related toxicity, with no benefit on survival compared to SAC.

Published
2020

17. The MIMIC Study: Prognostic Role and Cutoff Definition of Monocyte-to-Lymphocyte Ratio and Lactate Dehydrogenase Levels in Metastatic Colorectal Cancer

Author

Elena Ongaro, Debora Basile, Lorenzo Gerratana, Fabio Puglisi, Massimo Di Maio, Silvio Ken Garattini, Valentina Fanotto, F. Cortiula, Marcella Montico, Giacomo Pelizzari, C. Lisanti, Marco Audisio, Giovanni Gerardo Cardellino, Donatella Iacono, Gianpiero Fasola, Nicoletta Pella, Giuseppe Aprile, Angela Buonadonna, C. Corvaja, and Luisa Foltran

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Circulating biomarkers, LDH, Neutrophils, Colorectal cancer, Population, chemical and pharmacologic phenomena, Monocytes, MLR, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Lactate dehydrogenase, Gastrointestinal Cancer, Humans, Medicine, Lymphocytes, education, Lactate Dehydrogenases, Retrospective Studies, education.field_of_study, Metastatic colorectal cancer, business.industry, fungi, Hazard ratio, Cancer, hemic and immune systems, Prognosis, medicine.disease, Confidence interval, Immune biomarkers, 030104 developmental biology, chemistry, 030220 oncology & carcinogenesis, Colonic Neoplasms, Cohort, Biomarker (medicine), Colorectal Neoplasms, business
Abstract

Background Monocyte-to-lymphocyte ratio (MLR) and lactate dehydrogenase (LDH) levels are circulating biomarkers that provide information about tumor-related inflammation and immune suppression. This study aimed to evaluate the prognostic role of MLR and LDH in metastatic colorectal cancer (mCRC). Material and Methods This multicentric study analyzed a consecutive cohort of 528 patients with mCRC treated in 2009–2017. The whole population was randomly divided in training and validation cohort. The first was used to identify a threshold for MLR and to create the prognostic model with MLR and MLR-LDH combined (group 1: MLR-LDH low; group 2: MLR or LDH high; group 3: MLR-LDH high). The second cohort was used to validate the model. Results At the median follow-up of 55 months, median overall survival (OS) was 22 months. By multivariate analysis, high MLR >0.49 (hazard ratio [HR], 2.37; 95% confidence interval [C.I.], 1.39–4.04), high LDH (HR, 1.73; 95% C.I., 1.03–2.90) in the first model, group 2 (HR, 2.74; 95% C.I.; 1.62–4.66), and group 3 (HR, 3.73; 95% C.I., 1.94–7.18) in the combined model, had a worse prognosis in terms of OS. These data were confirmed both in the validation set and then in the whole cohort. Conclusion MLR and LDH are circulating cost-effective biomarkers, readily available in clinical practice, that can be useful for predicting the prognosis of patients with mCRC. Implications for Practice High monocyte-to-lymphocyte ratio (MLR) and lactate dehydrogenase (LDH) levels could be a sign of a tumor's recruitment of suppressive and inflammatory cells worsening prognosis of different types of cancer, including colorectal cancer (CRC). Currently, no data are available for metastatic CRC regarding a cutoff definition for MLR or the prognostic impact of MLR and MLR-LDH combined. The present study showed in the training cohort and confirmed in the validation and whole cohort that MLR is a reliable and independent laboratory biomarker, which is easy to use, to predict clinical outcomes in patients with mCRC. Moreover, MLR and composite MLR-LDH could potentially result in an incremental improvement in the prognostic value of these biomarkers, being used as stratification tools for patients with mCRC.

Published
2020

18. Abstract P5-14-08: Predictors of relative dose intensity and early dose reduction in patients with metastatic breast cancer treated with palbociclib and endocrine therapy

Author

Mattia Garutti, Alessandro Marco Minisini, Lucia Da Ros, Giacomo Pelizzari, C. Lisanti, Marta Bonotto, Simon Spazzapan, Mauro Mansutti, Debora Avoledo, Lorenzo Gerratana, Silvia Bolzonello, M. Giavarra, Debora Basile, E. Bertoli, L. Bortot, Michele Bartoletti, Gianpiero Fasola, Fabio Puglisi, S. Buriolla, Paola Di Nardo, and C. Corvaja

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Fulvestrant, business.industry, Cancer, Neutropenia, Palbociclib, medicine.disease, Metastatic breast cancer, Breast cancer, Planned Dose, Internal medicine, Cohort, medicine, business, medicine.drug
Abstract

Background: The combination of endocrine therapy with the cyclin-dependent kinases 4/6 inhibitor palbociclib was proven to be effective for the treatment of hormone receptor (HR)-positive/HER2-negative metastatic breast cancer (MBC). Although generally well tolerated, treatment delays and dose reductions are frequently observed with palbociclib, mainly due to severe neutropenia. Predictors of palbociclib-related toxicities are still unknown, as well as the clinical relevance of its relative dose intensity (RDI). Henceforth, this study aimed to identify baseline clinicopathological features associated with a RDI Methods: We reviewed data of 150 consecutive patients with HR-positive/HER2-negative MBC patients treated with palbociclib at two Italian cancer centers from 2017 to 2019. Eligible patients must have received at least 3 cycles of treatment. Those who experienced early suspension due to unacceptable toxicities were still eligible. RDI was calculated as the ratio of actual dose intensity (cumulative administered dose/treatment duration) and planned dose intensity (cumulative planned dose/planned treatment duration). The association of both RDI Results: Overall, 142 patients were deemed eligible. Of these patients, 98 (69.0%) were treated with palbociclib plus fulvestrant, 44 (31.0%) with palbociclib plus aromatase inhibitors, and 73 (51.4%) in the first-line setting. The median number of administered palbociclib cycles was 8 (range: 1-24) and 61 patients (43.0%) required at least a first-level dose reduction (29 within 3 months). Furthermore, the median time to first dose reduction was 3.22 months, with neutropenia being responsible for 85.24% of first-level dose reductions. In the whole cohort, median RDI was 90.5% (95.1% for patients without dose reduction and 80% for those who had received a dose reduction). Notably, 28 patients (19.7%) experienced a RDI Conclusions: In our analysis, baseline weight and WBC were statistically associated with a RDI Citation Format: Giacomo Pelizzari, Elisa Bertoli, Marco Giavarra, Carla Corvaja, Lorenzo Gerratana, Debora Basile, Michele Bartoletti, Camilla Lisanti, Lucia Bortot, Silvia Buriolla, Mattia Garutti, Debora Avoledo, Marta Bonotto, Lucia Da Ros, Silvia Bolzonello, Mauro Mansutti, Paola Di Nardo, Gianpiero Fasola, Simon Spazzapan, Alessandro M Minisini, Fabio Puglisi. Predictors of relative dose intensity and early dose reduction in patients with metastatic breast cancer treated with palbociclib and endocrine therapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-14-08.

Published
2020

19. Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: a multicentre, open-label, randomised, phase 3 trial

Author

Francesco Cognetti, Riccardo Ponzone, Mauro Mansutti, Giovanni Sanna, Matteo Lambertini, Lucia Del Mastro, Gruppo Italiano Mammella investigators, Antonio Durando, Silvia Mura, Fabio Puglisi, Stefano Tamberi, Alberto Ballestrero, Francesca Poggio, Grazia Arpino, Paolo Bruzzi, Giancarlo Bisagni, Ornella Garrone, Enrico Campadelli, Sabino De Placido, Andrea Michelotti, Ylenia Urracci, Claudia Bighin, Stefania Gori, Filippo Montemurro, Laura Amaducci, Carla Barone, Alessandra Fabi, Antonio Frassoldati, G. Moretti, Del Mastro, L., Mansutti, M., Bisagni, G., Ponzone, R., Durando, A., Amaducci, L., Campadelli, E., Cognetti, F., Frassoldati, A., Michelotti, A., Mura, S., Urracci, Y., Sanna, G., Gori, S., De Placido, S., Garrone, O., Fabi, A., Barone, C., Tamberi, S., Bighin, C., Puglisi, F., Moretti, G., Arpino, G., Ballestrero, A., Poggio, F., Lambertini, M., Montemurro, F., and Bruzzi, P.

Subjects
Selective Estrogen Receptor Modulators, medicine.medical_specialty, Time Factors, Time Factor, medicine.drug_class, Population, Selective Estrogen Receptor Modulator, Context (language use), Antineoplastic Agents, Breast Neoplasms, Disease-Free Survival, Drug Administration Schedule, Antineoplastic Agent, Breast cancer, Internal medicine, Clinical endpoint, Aromatase Inhibitor, Medicine, Humans, education, Mastectomy, Aged, Neoplasm Staging, education.field_of_study, Aromatase inhibitor, business.industry, Aromatase Inhibitors, Letrozole, Hazard ratio, Middle Aged, medicine.disease, Postmenopause, Tamoxifen, Oncology, Italy, Female, business, Breast Neoplasm, Human, medicine.drug
Abstract

Summary Background The benefit of extending aromatase inhibitor therapy beyond 5 years in the context of previous aromatase inhibitors remains controversial. We aimed to compare extended therapy with letrozole for 5 years versus the standard duration of 2–3 years of letrozole in postmenopausal patients with breast cancer who have already received 2–3 years of tamoxifen. Methods This multicentre, open-label, randomised, phase 3 trial was done at 69 hospitals in Italy. Women were eligible if they were postmenopausal at the time of study entry, had stage I–III histologically proven and operable invasive hormone receptor-positive breast cancer, had received adjuvant tamoxifen therapy for at least 2 years but no longer than 3 years and 3 months, had no signs of disease recurrence, and had an Eastern Cooperative Oncology Group performance status of 2 or lower. Patients were randomly assigned (1:1) to receive 2–3 years (control group) or 5 years (extended group) of letrozole (2·5 mg orally once a day). Randomisation, with stratification by centre, with permuted blocks of size 12, was done with a centralised, interactive, internet-based system that randomly generated the treatment allocation. Participants and investigators were not masked to treatment assignment. The primary endpoint was invasive disease-free survival in the intention-to-treat population. Safety analysis was done for patients who received at least 1 month of study treatment. This trial was registered with EudraCT, 2005-001212-44, and ClinicalTrials.gov, NCT01064635. Findings Between Aug 1, 2005, and Oct 24, 2010, 2056 patients were enrolled and randomly assigned to receive letrozole for 2–3 years (n=1030; control group) or for 5 years (n=1026; extended group). After a median follow-up of 11·7 years (IQR 9·5–13·1), disease-free survival events occurred in 262 (25·4%) of 1030 patients in the control group and 212 (20·7%) of 1026 in the extended group. 12-year disease-free survival was 62% (95% CI 57–66) in the control group and 67% (62–71) in the extended group (hazard ratio 0·78, 95% CI 0·65–0·93; p=0·0064). The most common grade 3 and 4 adverse events were arthralgia (22 [2·2%] of 983 patients in the control group vs 29 [3·0%] of 977 in the extended group) and myalgia (seven [0·7%] vs nine [0·9%]). There were three (0·3%) serious treatment-related adverse events in the control group and eight (0·8%) in the extended group. No deaths related to toxic effects were observed. Interpretation In postmenopausal patients with breast cancer who received 2–3 years of tamoxifen, extended treatment with 5 years of letrozole resulted in a significant improvement in disease-free survival compared with the standard 2–3 years of letrozole. Sequential endocrine therapy with tamoxifen for 2–3 years followed by letrozole for 5 years should be considered as one of the optimal standard endocrine treatments for postmenopausal patients with hormone receptor-positive breast cancer. Funding Novartis and the Italian Ministry of Health. Translation For the Italian translation of the abstract see Supplementary Materials section.

Published
2021

20. What Is the Optimal Duration of Adjuvant Mitotane Therapy in Adrenocortical Carcinoma? An Unanswered Question

Author

Soraya Puglisi, Felix Megerle, Paola Perotti, Isabelle Bourdeau, Marcus Quinkler, Martin Fassnacht, Alfredo Berruti, Ulrich Dischinger, Barbara Altieri, Darko Kastelan, André Lacroix, Massimo Terzolo, Letizia Canu, Paola Loli, Eric Baudin, Rossella Libé, Paola Berchialla, Harm R. Haak, Anna Calabrese, Filippo Ceccato, Vittoria Basile, Felix Beuschlein, RS: CAPHRI - R1 - Ageing and Long-Term Care, Interne Geneeskunde, University of Zurich, and Puglisi, Soraya

Subjects
Oncology, Recurrence free sur-vival, mitotane, medicine.medical_specialty, recurrence, Treatment duration, medicine.medical_treatment, 10265 Clinic for Endocrinology and Diabetology, adjuvant treatment, lcsh:Medicine, Medicine (miscellaneous), 610 Medicine & health, 030209 endocrinology & metabolism, recurrence free survival, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, adrenocortical cancer, medicine, Retrospective analysis, timing, Adrenocortical carcinoma, In patient, Mitotane, ddc:610, Radical surgery, business.industry, lcsh:R, 2701 Medicine (miscellaneous), medicine.disease, Discontinuation, 030220 oncology & carcinogenesis, Adjuvant treatment, Adrenocortical cancer, Recurrence, Timing, business, Adjuvant, medicine.drug
Abstract

A relevant issue on the treatment of adrenocortical carcinoma (ACC) concerns the optimal duration of adjuvant mitotane treatment. We tried to address this question, assessing whether a correlation exists between the duration of adjuvant mitotane treatment and recurrence-free survival (RFS) of patients with ACC. We conducted a multicenter retrospective analysis on 154 ACC patients treated for ≥12 months with adjuvant mitotane after radical surgery and who were free of disease at the mitotane stop. During a median follow-up of 38 months, 19 patients (12.3%) experienced recurrence. We calculated the RFS after mitotane (RFSAM), from the landmark time-point of mitotane discontinuation, to overcome immortal time bias. We found a wide variability in the duration of adjuvant mitotane treatment among different centers and also among patients cared for at the same center, reflecting heterogeneous practice. We did not find any survival advantage in patients treated for longer than 24 months. Moreover, the relationship between treatment duration and the frequency of ACC recurrence was not linear after stratifying our patients in tertiles of length of adjuvant treatment. In conclusion, the present findings do not support the concept that extending adjuvant mitotane treatment over two years is beneficial for ACC patients with low to moderate risk of recurrence.

Published
2021

21. Predicting respiratory failure in patients infected by SARS-CoV-2 by admission sex-specific biomarkers

Author

Pagano, MARIA TERESA, Daniela, Peruzzu, Busani, Luca, Marina, Pierdominici, Anna, Ruggieri, Andrea, Antinori, Gianpiero, D'Offizi, Nicola, Petrosillo, Fabrizio, Palmieri, Pierluca, Piselli, Cicalini, Stefania, Stefania, Notari, Nicastri, Emanuele, Chiara, Agrati, Ippolito, Giuseppe, Vaia, Francesco, Maria Cristina Gagliardi, Capobianchi, Maria Rosaria, Ortona, Elena, Manuela, Macchione, Rachele Di Lorenzo, Marta, Camici, Roberta, Gagliardini, Vita, Serena, Maffongelli, Gaetano, Eugenia, Milozzi, Francesca, Faraglia, Cerva, Carlotta, Silvia, Mosti, Davide Roberto Donno, Pierangelo, Chinello, Bordoni, Veronica, Alessandra, Sacchi, Tartaglia, Eleonora, Rita, Casetti, Grassi, Germana, Eleonora, Cimini, Maria Luisa Dupuis, Anticoli, Simona, Fecchi, Katia, Bellenghi, Maria, Puglisi, Rossella, Gianfranco, Mattia, Giada Pontecorvi and, Pagano, M. T., Peruzzu, D., Busani, L., Pierdominici, M., Ruggieri, A., Antinori, A., D'Offizi, G., Petrosillo, N., Palmieri, F., Piselli, P., Cicalini, S., Notari, S., Nicastri, E., Agrati, C., Ippolito, G., Vaia, F., Gagliardi, M. C., Capobianchi, M. R., Ortona, E., Macchione, M., Di Lorenzo, R., Camici, M., Gagliardini, R., Vita, S., Maffongelli, G., Milozzi, E., Faraglia, F., Cerva, C., Mosti, S., Donno, D. R., Chinello, P., Bordoni, V., Sacchi, A., Tartaglia, E., Casetti, R., Grassi, G., Cimini, E., Dupuis, M. L., Anticoli, S., Fecchi, K., Bellenghi, M., Puglisi, R., Mattia, G., and Pontecorvi, G.

Subjects
Adult, Male, ARDS, medicine.medical_specialty, Angiotensins, Physiology, Angiotensin1-7, Respiratory monitoring, Gender Studies, Angiotensin, Endocrinology, Internal medicine, Medicine, QP1-981, Humans, Testosterone, Respiratory system, angiotensin1-7, biomarkers, COVID-19, estrogen, gender, sex, testosterone, Respiratory Distress Syndrome, Sex Characteristics, Estradiol, business.industry, SARS-CoV-2, Research, Gender, Biomarker, Middle Aged, medicine.disease, Estrogen, Hospitalization, Respiratory failure, Absolute neutrophil count, Biomarker (medicine), Sex, Female, Angiotensin-Converting Enzyme 2, business, Respiratory Insufficiency, Biomarkers, Hormone, Human
Abstract

Background Several biomarkers have been identified to predict the outcome of COVID-19 severity, but few data are available regarding sex differences in their predictive role. Aim of this study was to identify sex-specific biomarkers of severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19. Methods Plasma levels of sex hormones (testosterone and 17β-estradiol), sex-hormone dependent circulating molecules (ACE2 and Angiotensin1-7) and other known biomarkers for COVID-19 severity were measured in male and female COVID-19 patients at admission to hospital. The association of plasma biomarker levels with ARDS severity at admission and with the occurrence of respiratory deterioration during hospitalization was analysed in aggregated and sex disaggregated form. Results Our data show that some biomarkers could be predictive both for males and female patients and others only for one sex. Angiotensin1-7 plasma levels and neutrophil count predicted the outcome of ARDS only in females, whereas testosterone plasma levels and lymphocytes counts only in males. Conclusions Sex is a biological variable affecting the choice of the correct biomarker that might predict worsening of COVID-19 to severe respiratory failure. The definition of sex specific biomarkers can be useful to alert patients to be safely discharged versus those who need respiratory monitoring.

Published
2021

22. T-DM1 versus pertuzumab, trastuzumab and a taxane as first-line therapy of early-relapsed HER2-positive metastatic breast cancer: an Italian multicenter observational study

Author

Matteo Lambertini, Daniele Generali, Antonio Frassoldati, Stefania Russo, Francesco Schettini, Antonio Pazzola, P. De Placido, Francesco Cognetti, Pierfranco Conte, Daniela Cianniello, Mariavittoria Locci, Mario Giuliano, A. Fabi, Filippo Montemurro, Sara Parola, Benedetta Conte, Valentina Guarneri, Fabio Puglisi, L. Del Mastro, M. De Laurentiis, Gaia Griguolo, S. De Placido, F. Riccardi, Grazia Arpino, Marta Bonotto, Giacomo Pelizzari, Claudia Bighin, Giuseppe Buono, Schettini, F., Conte, B., Buono, G., De Placido, P., Parola, S., Griguolo, G., Fabi, A., Bighin, C., Riccardi, F., Cianniello, D., De Laurentiis, M., Puglisi, F., Pelizzari, G., Bonotto, M., Russo, S., Frassoldati, A., Pazzola, A., Montemurro, F., Lambertini, M., Guarneri, V., Cognetti, F., Locci, M., Generali, D., Conte, P., De Placido, S., Giuliano, M., Arpino, G., and Del Mastro, L.

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, T-DM1, Breast Neoplasms, Antibodies, Monoclonal, Humanized, Breast cancer, breast cancer, Trastuzumab, pertuzumab, Retrospective Studie, Internal medicine, HER2, Taxoid, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Prospective Studies, first-line, Original Research, Retrospective Studies, Taxane, Antineoplastic Combined Chemotherapy Protocol, business.industry, Hazard ratio, medicine.disease, Metastatic breast cancer, Confidence interval, trastuzumab, Prospective Studie, Italy, Taxoids, Female, Pertuzumab, Neoplasm Recurrence, Local, business, medicine.drug, Human
Abstract

Background The current standard first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive (+) metastatic breast cancer is the combination of pertuzumab, trastuzumab and a taxane (P + T + taxane), while standard second-line is ado-trastuzumab-emtansine (T-DM1). The registration trial of pertuzumab, however, did not include early-relapsing patients, defined as patients experiencing tumor relapse ≤12 months from the end of (neo)adjuvant anti-HER2 therapy. Conversely, the pivotal trial of T-DM1 included some patients relapsing ≤6 months after the end of (neo)adjuvant trastuzumab. Thus, a proportion of early-relapsing patients are currently eligible to receive T-DM1 as first-line treatment. Nevertheless, no direct comparison exists between the two regimens in this clinical setting. Patients and methods We retrospectively compared T-DM1 versus P + T + taxane as first-line treatment in two cohorts of early-relapsing patients in an Italian ‘real-world’ setting, involving 14 public health care institutions. The primary endpoint was progression-free survival. Secondary endpoints included patients' characterization, overall survival and post-progression survival. Univariate and multivariate analyses were carried out. All tests were two-sided and a P ≤ 0.05 was considered statistically significant. Results Among 1252 screened patients, 75 met the inclusion criteria. Forty-four (58.7%) received P + T + taxane and 31 (41.3%) received T-DM1. The two cohorts showed similar characteristics of aggressiveness and no significant differences in treatment history. T-DM1, compared with P + T + taxane was associated with worse progression-free survival (adjusted hazard ratio: 2.26, 95% confidence interval: 1.13-4.52, P = 0.021) and overall survival (adjusted hazard ratio: 3.95, 95% confidence interval: 1.38-11.32, P = 0.010), irrespective of previous (neo)adjuvant treatment, age, hormone receptors status, time-to-relapse (≤6 months or within 6-12 months) and presence of visceral/brain metastases. No differences were observed in post-progression survival (P = 0.095). Conclusions Our study suggests superiority for P + T + taxane over T-DM1 as up-front treatment of early-relapsing HER2+ metastatic breast cancer, which merits further assessment in larger and prospective trials., Highlights • This is the first study comparing pertuzumab + trastuzumab + taxane (P + T + taxane) with T-DM1 in early-relapsing HER2+ MBC. • The majority of early-relapsing HER2+ MBC have high-grade, node-positive, large primary tumors. • First-line T-DM1 compared with P + T + taxane is associated with worse progression-free survival. • First-line T-DM1 compared with P + T + taxane is associated with worse overall survival. • Post-progression survival does not differ between the two treatments cohorts.

Published
2021

23. SARS-CoV-2 infection and acute ischemic stroke in Lombardy, Italy

Author

Matteo Cortinovis, Elisa Raimondi, Federico Pozzi, Alessandro Padovani, Laura Fusi, Federico Carimati, Sonia Bonacina, Mario Grassi, Valentina Mazzoleni, Alessandro Prelle, Anna Magherini, Simonetta Gerevini, Andrea Pilotto, Manuel Corato, Valeria De Giuli, Enrico Premi, Valentina Puglisi, Giorgio Silvestrelli, Francesco Santangelo, Alessia Giossi, Davide Sangalli, Maurizio Versino, Simone Beretta, Giuditta Giussani, Francesca Barbieri, Giampiero Grampa, Rubjona Xhani, Susanna Diamanti, Daria Valeria Roccatagliata, Alfonso Ciccone, Stefano Masciocchi, Elio Agostoni, Nicola Rifino, Massimo Gamba, Maria Sessa, Anna Cavallini, Sara La Gioia, Alberto Benussi, Bruno Censori, Martina Locatelli, Alessandro Pezzini, Andrea Salmaggi, Fernando Palluzzi, Mauro Magoni, Luisa Vinciguerra, Debora Pezzini, Simona Marcheselli, Carlo Ferrarese, Pezzini, A, Grassi, M, Silvestrelli, G, Locatelli, M, Rifino, N, Beretta, S, Gamba, M, Raimondi, E, Giussani, G, Carimati, F, Sangalli, D, Corato, M, Gerevini, S, Masciocchi, S, Cortinovis, M, La Gioia, S, Barbieri, F, Mazzoleni, V, Pezzini, D, Bonacina, S, Pilotto, A, Benussi, A, Magoni, M, Premi, E, Prelle, A, Agostoni, E, Palluzzi, F, De Giuli, V, Magherini, A, Roccatagliata, D, Vinciguerra, L, Puglisi, V, Fusi, L, Diamanti, S, Santangelo, F, Xhani, R, Pozzi, F, Grampa, G, Versino, M, Salmaggi, A, Marcheselli, S, Cavallini, A, Giossi, A, Censori, B, Ferrarese, C, Ciccone, A, Sessa, M, and Padovani, A

Subjects
Male, Percentile, medicine.medical_specialty, Logistic regression, Brain Ischemia, Internal medicine, medicine, Humans, Hospital Mortality, Risk factor, Stroke, Survival analysis, Ischemic Stroke, Retrospective Studies, Original Communication, SARS-CoV-2, business.industry, Mortality rate, COVID-19, Atrial fibrillation, medicine.disease, Italy, Neurology, Risk factors, Viral infection, Etiology, Neurology (clinical), business
Abstract

Objective To characterize patients with acute ischemic stroke related to SARS-CoV-2 infection and assess the classification performance of clinical and laboratory parameters in predicting in-hospital outcome of these patients. Methods In the setting of the STROKOVID study including patients with acute ischemic stroke consecutively admitted to the ten hub hospitals in Lombardy, Italy, between March 8 and April 30, 2020, we compared clinical features of patients with confirmed infection and non-infected patients by logistic regression models and survival analysis. Then, we trained and tested a random forest (RF) binary classifier for the prediction of in-hospital death among patients with COVID-19. Results Among 1013 patients, 160 (15.8%) had SARS-CoV-2 infection. Male sex (OR 1.53; 95% CI 1.06–2.27) and atrial fibrillation (OR 1.60; 95% CI 1.05–2.43) were independently associated with COVID-19 status. Patients with COVID-19 had increased stroke severity at admission [median NIHSS score, 9 (25th to75th percentile, 13) vs 6 (25th to75th percentile, 9)] and increased risk of in-hospital death (38.1% deaths vs 7.2%; HR 3.30; 95% CI 2.17–5.02). The RF model based on six clinical and laboratory parameters exhibited high cross-validated classification accuracy (0.86) and precision (0.87), good recall (0.72) and F1-score (0.79) in predicting in-hospital death. Conclusions Ischemic strokes in COVID-19 patients have distinctive risk factor profile and etiology, increased clinical severity and higher in-hospital mortality rate compared to non-COVID-19 patients. A simple model based on clinical and routine laboratory parameters may be useful in identifying ischemic stroke patients with SARS-CoV-2 infection who are unlikely to survive the acute phase.

Published
2021

24. Histological patterns and intra-tumor heterogeneity as prognostication tools in high grade serous ovarian cancers

Author

Renzo Barbazza, Serena Bonin, L. Bortot, Giorgio Stanta, Eros Azzalini, Fabio Puglisi, Vincenzo Canzonieri, Michele Bartoletti, Giorgio Giorda, Azzalini, Ero, Barbazza, Renzo, Stanta, Giorgio, Giorda, Giorgio, Bortot, Lucia, Bartoletti, Michele, Puglisi, Fabio, Canzonieri, Vincenzo, and Bonin, Serena

Subjects
Oncology, Cohort Studies, Retrospective Studie, Ovarian carcinoma, 80 and over, Medicine, Aged, 80 and over, Ovarian Neoplasms, BRCA1 Protein, Obstetrics and Gynecology, Middle Aged, Debulking, Prognosis, Immunohistochemistry, Progression-Free Survival, Survival Rate, Cystadenocarcinoma, Serou, Serous fluid, Female, SET, Human, Adult, Morphology, medicine.medical_specialty, Psammoma body, Prognosi, Cystadenocarcinoma, Architectural pattern, Shannon diversity index, Internal medicine, Humans, HGSOC, Progression-free survival, Aged, Neoplasm Staging, Retrospective Studies, Classic, business.industry, Tumor-infiltrating lymphocytes, Malignant Ovarian Neoplasm, Ovarian Neoplasm, Serous, medicine.disease, Cystadenocarcinoma, Serous, Heterogeneity, Cohort Studie, business, Ovarian cancer
Abstract

Objective High grade serous ovarian carcinoma (HGSOC) is the most common type of malignant ovarian neoplasm and the main cause of ovarian cancer related deaths worldwide. Although novel biomarkers such as homologous recombination deficiency testing have been implemented into the clinical decision-making algorithm since diagnosis, morphological classification and immunohistochemistry analysis are essential for diagnostic purpose. This study aims at identifying histologic and clinical features that can be predictive of patients' prognosis. Methods Morphological and architectural characterization including SET (Solid-Endometroid-Transitional)/Classic features was carried out in a cohort of 234 patients analyzing 695 slides. From each slide tumor infiltrating lymphocyte (TILs), the presence of necrosis, the number of mitoses, the presence of psammoma bodies, giant cells and atypical mitoses were recorded. Morphological heterogeneity was quantified by the Shannon's diversity index (SDI) considering the percentage of each architectural pattern per patient's slide. Results The frequency of architectural patterns and morphological variables varied with respect of the surgical strategy (primary debulking surgery vs interval surgery after neoadjuvant chemotherapy). HGSOCs exhibiting SET features had a longer overall as well as progression free survival. Among SET features, pseudo-endometrioid and transitional like patterns had the best outcome, while it was heterogenous for solid pattern, that had better outcome for BRCA 1 negative and less heterogeneous tumors. In patients submitted to neoadjuvant chemotherapy a higher intratumor heterogeneity as defined by SDI was a negative independent prognostic factor. Conclusions A comprehensive histological examination considering architectural patterns and their heterogeneity can help in prognostication of HGSOCs.

Published
2021

25. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

26. Find the flame: Predictive biomarkers for immunotherapy in melanoma

Author

Fabio Puglisi, Iris Zalaudek, S. Buriolla, Serena Bonin, Mattia Garutti, Maria Antonietta Pizzichetta, E. Bertoli, Garutti, M., Bonin, S., Buriolla, S., Bertoli, E., Pizzichetta, M. A., Zalaudek, I., and Puglisi, F.

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Context (language use), Pembrolizumab, Review, Biomarkers, Checkpoint inhibitors, CTLA-4, Immunotherapy, Melanoma, Meta-analysis, Nivolumab, PD-1, PDL-1, lcsh:RC254-282, meta-analysi, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, melanoma, medicine, Predictive biomarker, nivolumab, business.industry, biomarkers, immunotherapy, checkpoint inhibitors, pembrolizumab, meta-analysis, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, checkpoint inhibitor, 030104 developmental biology, 030220 oncology & carcinogenesis, biomarker, business
Abstract

Simple Summary Immunotherapy has revolutionized the therapeutic landscape of melanoma. However, the absence of clinically validated predictive biomarkers is one of the major causes of unpredictable efficacy of immunotherapy. Indeed, the availability of predictive biomarkers could allow a better stratification of patients, suggesting which type of drugs should be used in a certain clinical context and guiding clinicians in escalating or de-escalating therapy. However, the difficulty in obtaining clinically useful predictive biomarkers reflects the deep complexity of tumor biology. Herein, we review the available literature to depict the most useful or promising biological biomarker able to predict immunotherapy response in melanoma. We also make a meta-analysis regarding PDL1 expression in melanoma and immune checkpoint response. Abstract Immunotherapy has revolutionized the therapeutic landscape of melanoma. In particular, checkpoint inhibition has shown to increase long-term outcome, and, in some cases, it can be virtually curative. However, the absence of clinically validated predictive biomarkers is one of the major causes of unpredictable efficacy of immunotherapy. Indeed, the availability of predictive biomarkers could allow a better stratification of patients, suggesting which type of drugs should be used in a certain clinical context and guiding clinicians in escalating or de-escalating therapy. However, the difficulty in obtaining clinically useful predictive biomarkers reflects the deep complexity of tumor biology. Biomarkers can be classified as tumor-intrinsic biomarkers, microenvironment biomarkers, and systemic biomarkers. Herein we review the available literature to classify and describe predictive biomarkers for checkpoint inhibition in melanoma with the aim of helping clinicians in the decision-making process. We also performed a meta-analysis on the predictive value of PDL-1.

Published
2021

27. A multicenter epidemiological study on second malignancy in non-syndromic pheochromocytoma/paraganglioma patients in Italy

Author

Luigi Petramala, Tonino Ercolino, Valentina Morelli, Marialuisa Appetecchia, Antongiulio Faggiano, Francesca Schiavi, P. Razzore, Uberta Verga, Anna Pia, Barbara Altieri, Francesca Brignardello, Massimo Terzolo, Antonio Concistrè, Antonio Stigliano, Soraya Puglisi, Micaela Pellegrino, Mario Maggi, Michaela Luconi, Giuseppe Opocher, Paola Berchialla, Massimo Mannelli, Emanuela Arvat, Mauro Maccario, Mirko Parasiliti-Caprino, Giuseppina De Filpo, Jacopo Burrello, Roberta Modica, Letizia Canu, Stefania Zovato, Alfonso Massimiliano Ferrara, Maura Arosio, Giuseppe Reimondo, Claudio Letizia, Elena Rapizzi, Canu, Letizia, Puglisi, Soraya, Berchialla, Paola, DE FILPO, Giuseppina, Brignardello, Francesca, Schiavi, Francesca, Ferrara, ALFONSO MASSIMILIANO, Zovato, Stefania, Luconi, Michaela, Anna, Pia, Appetecchia, Marialuisa, Arvat, Emanuela, Letizia, Claudio, Maccario, Mauro, Parasiliti-Caprino, Mirko, Altieri, Barbara, Faggiano, Antongiulio, Modica, Roberta, Morelli, Valentina, Arosio, Maura, Verga, Uberta, Pellegrino, Micaela, Petramala, Luigi, Concistrè, Antonio, Razzore, Paola, Ercolino, Tonino, Rapizzi, Elena, Maggi, Mario, Stigliano, Antonio, Burrello, Jacopo, Terzolo, Massimo, Opocher, Giuseppe, Mannelli, Massimo, and Matteo REIMONDO, Giuseppe

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Population, genetic analysis, Malignancy, Mortality surveillance, Article, Pheochromocytoma, paraganglioma, Breast cancer, Paraganglioma, Internal medicine, medicine, ddc:610, education, Thyroid cancer, RC254-282, epidemiology, mortality surveillance, pheochromocytoma, education.field_of_study, business.industry, Incidence (epidemiology), Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, mortality, Standardized mortality ratio, surveillance, business
Abstract

No studies have carried out an extensive analysis of the possible association between non-syndromic pheochromocytomas and paragangliomas (PPGLs) and other malignancies. To assess the risk of additional malignancy in PPGL, we retrospectively evaluated 741 patients with PPGLs followed-up in twelve referral centers in Italy. Incidence of second malignant tumors was compared between this cohort and Italian patients with two subsequent malignancies. Among our patients, 95 (12.8%) developed a second malignant tumor, which were mainly prostate, colorectal and lung/bronchial cancers in males, breast cancer, differentiated thyroid cancer and melanoma in females. The standardized incidence ratio was 9.59 (95% CI 5.46–15.71) in males and 13.21 (95% CI 7.52–21.63) in females. At multivariable analysis, the risk of developing a second malignant tumor increased with age at diagnosis (HR 2.50, 95% CI 1.15–5.44, p = 0.021 for 50–59 vs. &lt, 50-year category, HR 3.46, 95% CI 1.67–7.15, p &lt, 0.001 for &gt, 60- vs. &lt, 50-year). In patients with available genetic evaluation, a positive genetic test was inversely associated with the risk of developing a second tumor (HR 0.25, 95% CI 0.10–0.63, p = 0.003). In conclusion, PPGLs patients have higher incidence of additional malignant tumors compared to the general population who had a first malignancy, which could have an impact on the surveillance strategy.

Published
2021

28. EPV036/#142 European network for gynaecological oncological trial (ENGOT)-CX11/gynecologic oncology group (GOG) 3047/keynote-A18: phase 3 trial of pembrolizumab plus chemoradiotherapy in high-risk locally advanced cervical cancer

Author

Linda R. Duska, Y. Xiang, M Puglisi, Benoit You, M-R Christiaens, A Oaknin, D Lorusso, Robert L. Coleman, J Sehouli, Leslie M Randall, M Mirza, C Marth, Cagatay Taskiran, David Cibula, Sandro Pignata, Angélica Nogueira-Rodrigues, K Yamada, N Colombo, Jacob Korach, and Kosei Hasegawa

Subjects
Cervical cancer, Oncology, medicine.medical_specialty, business.industry, Internal medicine, Locally advanced, Medicine, Pembrolizumab, Gynecologic oncology, business, medicine.disease, Chemoradiotherapy
Published
2021

29. Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists on Renin-Angiotensin-Aldosterone System

Author

Alessandro Rossini, Massimo Terzolo, Francesca Dughera, Roberta Poli, Anna Pia, Soraya Puglisi, and Giuseppe Reimondo

Subjects
Blood Glucose, Glycosuria, cardiovascular risk, medicine.medical_specialty, diabetes mellitus type 2, Mini Review, Endocrinology, Diabetes and Metabolism, glucagon-like peptide-1 receptor agonist, aldosterone, cardiovascular disease, diabetic kidney disease, renin, sodium-glucose cotransporter-2 inhibitor, Plasma renin activity, Glucagon-Like Peptide-1 Receptor, Diseases of the endocrine glands. Clinical endocrinology, Natriuresis, Renin-Angiotensin System, chemistry.chemical_compound, Endocrinology, Internal medicine, Renin–angiotensin system, medicine, Humans, Sodium-Glucose Transporter 2 Inhibitors, Glucagon-like peptide 1 receptor, Aldosterone, Reabsorption, business.industry, RC648-665, Angiotensin II, chemistry, medicine.symptom, business
Abstract

Sodium-glucose cotransporters inhibitors (SGLT2-i) and GLP-1 receptor agonists (GLP1-RA) are glucose-lowering drugs that are proved to reduce the cardiovascular (CV) risk in type 2 diabetes mellitus (T2DM). In this process, the renin-angiotensin-aldosterone system (RAAS) is assumed to play a role. The inhibition of SGLT2 improves hyperglycemia hampering urinary reabsorption of glucose and inducing glycosuria. This “hybrid” diuretic effect, which couples natriuresis with osmotic diuresis, potentially leads to systemic RAAS activation. However, the association between SGLT2-i and systemic RAAS activation is not straightforward. Available data indicate that SGLT2-i cause plasma renin activity (PRA) increase in the early phase of treatment, while PRA and aldosterone levels remain unchanged in chronic treated patients. Furthermore, emerging studies provide evidence that SGLT2-i might have an interfering effect on aldosterone/renin ratio (ARR) in patients with T2DM, due to their diuretic and sympathoinhibition effects. The cardio- and reno-protective effects of GLP-1-RA are at least in part related to the interaction with RAAS. In particular, GLP1-RA counteract the action of angiotensin II (ANG II) inhibiting its synthesis, increasing the inactivation of its circulating form and contrasting its action on target tissue like glomerular endothelial cells and cardiomyocytes. Furthermore, GLP1-RA stimulate natriuresis inhibiting Na+/H+ exchanger NHE-3, which is conversely activated by ANG II. Moreover, GLP1 infusion acutely reduces circulating aldosterone, but this effect does not seem to be chronically maintained in patients treated with GLP1-RA. In conclusion, both SGLT2-i and GLP1-RA seem to have several effects on RAAS, though additional studies are needed to clarify this relationship.

Published
2021

30. 261 ENGOT-cx11/GOG 3047/KEYNOTE-A18: phase 3 randomized study of pembrolizumab + chemoradiotherapy for high-risk locally advanced cervical cancer

Author

K Yamada, Jacob Korach, Mirza, M-R Christiaens, Cagatay Taskiran, Sandro Pignata, Domenica Lorusso, Christian Marth, Leslie M Randall, N Colombo, Jalid Sehouli, David Cibula, Robert L. Coleman, Angélica Nogueira-Rodrigues, A Oaknin, Benoit You, Linda R. Duska, Y. Xiang, M Puglisi, and Kosei Hasegawa

Subjects
Oncology, Cervical cancer, medicine.medical_specialty, business.industry, medicine.medical_treatment, Brachytherapy, Pembrolizumab, medicine.disease, law.invention, Radiation therapy, Randomized controlled trial, Response Evaluation Criteria in Solid Tumors, law, Internal medicine, medicine, External beam radiotherapy, business, Chemoradiotherapy
Abstract

Introduction/Background* High-risk locally advanced cervical cancer has a poor prognosis, and more than half of patients recur in 2 years. External beam radiotherapy (EBRT) with concurrent chemotherapy followed by brachytherapy is the standard of care for locally advanced cervical cancer. The immunostimulatory activity of the PD-1 inhibitor pembrolizumab may be enhanced by concurrent chemoradiotherapy (CCRT). After the KEYNOTE-158 study, in which pembrolizumab showed durable antitumor activity, pembrolizumab monotherapy was approved for patients with PD-L1–positive recurrent or metastatic cervical cancer who progressed during or after chemotherapy. ENGOT-cx11/GOG 3047/KEYNOTE-A18 (NCT04221945) is a phase 3, randomized, placebo-controlled study evaluating pembrolizumab with CCRT for the treatment of high-risk, locally advanced cervical cancer. Methodology Approximately 980 patients with high-risk (International Federation of Gynecology and Obstetrics 2014 stage IB2-IIB with node-positive disease or stage III-IVA), locally advanced, histologically confirmed cervical cancer who have not received systemic therapy, immunotherapy, definitive surgery, or radiation will be randomized 1:1 to receive either 5 cycles of pembrolizumab 200 mg every 3 weeks (Q3W) + CCRT followed by 15 cycles of pembrolizumab 400 mg Q6W or 5 cycles of placebo Q3W + CCRT followed by 15 cycles of placebo Q6W. CCRT includes 5 cycles (optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT followed by brachytherapy. Randomization is stratified by planned EBRT type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), cancer stage at screening (stage IB2-IIB vs III-IVA), and planned total radiotherapy dose. Treatment will continue until the patient has received 20 cycles of pembrolizumab (5 cycles 200 mg Q3W, 15 cycles 400 mg Q6W) vs placebo (~2 years) or until disease progression, unacceptable toxicity, or withdrawal. Primary endpoints are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 by investigator and overall survival (OS). Secondary endpoints include PFS by blinded independent central review, PFS at 2 years, OS at 3 years, complete response at 12 weeks, objective response rate, PFS and OS by PD-L1 status, quality of life, and safety. Enrolment began May 2020 and is planned for 193 sites in 30 countries. Klikněte nebo klepněte sem a zadejte text.

Published
2021

31. Lactic Acid Bacteria Strains Differently Modulate Gut Microbiota and Metabolic and Immunological Parameters in High-Fat Diet-Fed Mice

Author

Paola Gauffin-Cano, Emanuel Fabersani, Matías Russo, Antonela Marquez, Roxana Beatriz Medina, Romina Ross, Edoardo Puglisi, Sebastián Torres, and Cecilia Alejandra Fontana

Subjects
lactobacilli, medicine.medical_specialty, adipocytes, Endocrinology, Diabetes and Metabolism, Adipose tissue, Gut flora, law.invention, chemistry.chemical_compound, Probiotic, Immune system, law, Lactobacillus, Adipocyte, Internal medicine, medicine, TX341-641, Nutrition, Original Research, Nutrition and Dietetics, gut microbiota, biology, Nutrition. Foods and food supply, Leptin, biology.organism_classification, macrophages, Endocrinology, chemistry, Settore AGR/16 - MICROBIOLOGIA AGRARIA, high-fat diet-fed mice, probiotic, Ex vivo, Food Science
Abstract

Background: Dietary strategies, including the use of probiotics as preventive agents that modulate the gut microbiota and regulate the function of adipose tissue, are suitable tools for the prevention or amelioration of obesity and its comorbidities. We aimed to evaluate the effect of lactic acid bacteria (LAB) with different adipo- and immuno-modulatory capacities on metabolic and immunological parameters and intestinal composition microbiota in high-fat-diet-induced in mice fed a high-fat dietMethods: Balb/c weaning male mice were fed a standard (SD) or high-fat diet (HFD) with or without supplementation with Limosilactobacillus fermentum CRL1446 (CRL1446), Lactococcus lactis CRL1434 (CRL1434), or Lacticaseibacillus casei CRL431 (CRL431) for 45 days. Biochemical and immunological parameters, white-adipose tissue histology, gut microbiota composition, and ex vivo cellular functionality (adipocytes and macrophages) were evaluated in SD and HFD mice.Results: CRL1446 and CRL1434 administration, unlike CRL431, induced significant changes in the body and adipose tissue weights and the size of adipocytes. Also, these strains caused a decrease in plasmatic glucose, cholesterol, triglycerides, leptin, TNF-α, IL-6 levels, and an increase of IL-10. The CRL1446 and CRL1434 obese adipocyte in ex vivo functionality assays showed, after LPS stimulus, a reduction in leptin secretion compared to obese control, while with CRL431, no change was observed. In macrophages from obese mice fed with CRL1446 and CRL1434, after LPS stimulus, lower levels of MCP-1, TNF-α, IL-6 compared to obese control were observed. In contrast, CRL431 did not induce modification of cytokine values. Regarding gut microbiota, all strain administration caused a decrease in Firmicutes/Bacteroidetes index and diversity. As well as, related to genus results, all strains increased, mainly the genera Alistipes, Dorea, Barnesiella, and Clostridium XIVa. CRL1446 induced a higher increase in the Lactobacillus genus during the study period.Conclusions: The tested probiotic strains differentially modulated the intestinal microbiota and metabolic/immunological parameters in high-fat-diet-induced obese mice. These results suggest that CRL1446 and CRL1434 strains could be used as adjuvant probiotics strains for nutritional treatment to obesity and overweight. At the same time, the CRL431 strain could be more beneficial in pathologies that require regulation of the immune system.

Published
2021

32. Treatment With Baricitinib for Patients With COVID-19 Infections: A Case-Series Study

Author

Luca Donati, M. Terzitta, Venerino Poletti, Claudia Ravaglia, Francesco Landi, Stefano Oldani, Siro Simoncelli, Corrado Ghirotti, Sara Piciucchi, Lara Bertolovic, Serena Bensai, Cristiano Colinelli, Gianfranco Ravaglia, and Silvia Puglisi

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Baricitinib, Internal medicine, medicine, business, Case series
Published
2021

33. A Multidisciplinary Multicenter Study Evaluating Risk Factors, Prevalence and Characteristics of Post-COvid-19 Interstitial Lung Syndrome (PCOILS)

Author

Edoardo Cavigli, Nicola Sverzellati, Valentina Luzzi, Venerino Poletti, Marco Confalonieri, Sara Tomassetti, Diletta Cozzi, Adele Torricella, Catherine Klersy, Antonella Caminati, Leonardo Gori, Silvia Puglisi, Stefania Ferraro, Giulia Biadene, Elena Bargagli, Sergio Harari, Teresita Aloe, Emanuela Barisione, Tiberio Oggionni, Raffaele Scala, Federica Meloni, Sara Piciucchi, Claudia Ravaglia, Vittorio Miele, Martina Bonifazi, and Stefano Gasparini

Subjects
medicine.medical_specialty, Lung, medicine.anatomical_structure, Coronavirus disease 2019 (COVID-19), Multicenter study, Multidisciplinary approach, business.industry, Internal medicine, medicine, business
Published
2021

34. Myocardial infarction with non-obstructive coronary arteries (MINOCA): Intracoronary imaging-based diagnosis and management

Author

Sebastiano Puglisi, Vincenzo Sucato, Gabriella Testa, Salvatore Evola, Alfredo R. Galassi, Giuseppina Novo, Sucato V, Testa G, Puglisi S, Evola S, Galassi AR, and Novo G

Subjects
medicine.medical_specialty, Myocarditis, Myocardial Infarction, Context (language use), Coronary Artery Disease, 030204 cardiovascular system & hematology, Coronary Angiography, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Myocardial infarction with non-obstructive coronary arterie, Risk Factors, Internal medicine, Intravascular ultrasound, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, medicine.diagnostic_test, Optical coherence tomography, business.industry, Takotsubo syndrome, Intracoronary imaging, medicine.disease, Coronary Vessels, Plaque, Atherosclerotic, Pulmonary embolism, Coronary arteries, medicine.anatomical_structure, Angiography, Cardiology, Cardiology and Cardiovascular Medicine, business
Abstract

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is defined by clinical evidence of myocardial infarction (MI) with normal or near-normal coronary arteries on angiography. This condition is present in about 5% to 25% of patients presenting with acute coronary syndromes. MINOCA is a working diagnosis. Current guidelines and consensus recommend identification of underlying causes of MINOCA in order to optimize treatment, improve prognosis, and promote prevention of recurrent myocardial infarction. An accurate evaluation of patient history, symptoms and use of invasive and non-invasive imaging should lead to identification of epicardial or microvascular causes of MINOCA and differentiation from non-ischemic myocardial injury due to both cardiac (e.g. myocarditis) and non-cardiac disease (e.g. pulmonary embolism). In this review, we highlight the role of coronary imaging in differential diagnosis of patients presenting with MINOCA. Intravascular ultrasound and optical coherence tomography are well known technologies used in different settings from acute to chronic coronary syndromes. In MINOCA patients, coronary imaging could help to identify pathological alterations of the epicardial vessels that are not visible by coronary angiography such as plaque disruption, coronary dissection, coronary thromboembolism, coronary spasm, and coronary artery disease in patients presenting with takotsubo syndrome. In future, the widespread use of these technologies, in the right clinical context, could lead to optimization and personalization of treatment, and to better prognosis of patients presenting with MINOCA.

Published
2020

35. EFFECT: A randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Antonella Brunello, Silvana Leo, Emanuela Magnolfi, Sabino De Placido, Raffaella Palumbo, Alessandro Marco Minisini, Elena Rota Caremoli, Elena Zafarana, Sara Donati, Emanuela Risi, Anna Rachelle Mislang, Giuseppe Mottino, Luca Boni, Dimitri Becheri, Rossana Berardi, Mirco Pistelli, Fabio Puglisi, Amelia McCartney, Rebecca Pedersini, Laura Biganzoli, Veronica Parolin, Simon Spazzapan, Giuseppina Sanna, Saverio Cinieri, Marco Colleoni, Laura Orlando, Biganzoli, Laura, Cinieri, Saverio, Berardi, Rossana, Pedersini, Rebecca, Mccartney, Amelia, Minisini, Alessandro Marco, Caremoli, Elena Rota, Spazzapan, Simon, Magnolfi, Emanuela, Brunello, Antonella, Risi, Emanuela, Palumbo, Raffaella, Leo, Silvana, Colleoni, Marco, Donati, Sara, De Placido, Sabino, Orlando, Laura, Pistelli, Mirco, Parolin, Veronica, Mislang, Anna, Becheri, Dimitri, Puglisi, Fabio, Sanna, Giuseppina, Zafarana, Elena, Boni, Luca, and Mottino, Giuseppe

Subjects
Phases of clinical research, law.invention, Efficacy, 0302 clinical medicine, Breast cancer, Randomized controlled trial, law, Functional decline, Clinical endpoint, Age Factor, Older adult, Aged, 80 and over, Age Factors, Prognosis, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Survival Rate, 030220 oncology & carcinogenesis, Older adults, Metastatic, Female, Breast Neoplasm, Research Article, Human, medicine.medical_specialty, Paclitaxel, Prognosi, Breast Neoplasms, Nab-paclitaxel, lcsh:RC254-282, 03 medical and health sciences, Albumins, Internal medicine, medicine, Humans, Neoplasm Invasiveness, Progression-free survival, Adverse effect, Survival rate, Aged, Neoplasm Staging, Neoplasm Invasivene, Dose-Response Relationship, Drug, Toxicity, business.industry, Albumin, medicine.disease, Antineoplastic Agents, Phytogenic, business
Abstract

Background Limited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population. Methods EFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m2 (arm A) or 125 mg/m2 (arm B) on days 1, 8, and 15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death. In each arm, the null hypothesis that the median EFS would be ≤ 7 months was tested against a one-sided alternative according to the Brookmeyer Crowley test. Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety. Results After a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9–8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2–9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2–3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2–3 arm A vs B, 19% and 38%, respectively). Conclusion Pre-specified outcomes were similar in both treatment arms. However, 100 mg/m2 was significantly better tolerated with fewer neurotoxicity-related events, representing a more feasible dose to be recommended for older patients with advanced disease. Trial registration EudraCT, 2012-002707-18. Registered on June 4, 2012. NIH ClinicalTrials.gov, NCT02783222. Retrospectively registered on May 26, 2016.

Published
2020

36. Role of bruton’s tyrosine kinase in stage III colorectal cancer

Author

Claudio Belluco, Debora Basile, Tiziana Perin, Angela Buonadonna, Marialuisa Lavitrano, Silvio Ken Garattini, Maria Grazia Cerrito, Gianmaria Miolo, Lorenzo Gerratana, Emanuela Grassilli, G. Bertola, Vincenzo Canzonieri, Renato Cannizzaro, Antonino De Paoli, Fabio Puglisi, Basile, D., Gerratana, L., Buonadonna, A., Garattini, S. K., Perin, T., Grassilli, E., Miolo, G., Cerrito, M. G., Belluco, C., Bertola, G., De Paoli, A., Cannizzaro, R., Lavitrano, M., Puglisi, F., Canzonieri, V., Basile, D, Gerratana, L, Buonadonna, A, Garattini, S, Perin, T, Grassilli, E, Miolo, G, Cerrito, M, Belluco, C, Bertola, G, De Paoli, A, Cannizzaro, R, Lavitrano, M, Puglisi, F, and Canzonieri, V

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Colorectal cancer, lcsh:RC254-282, Article, 03 medical and health sciences, 0302 clinical medicine, Bruton’s tyrosine kinase, Internal medicine, medicine, Bruton's tyrosine kinase, Stage (cooking), BTK, Colon cancer, Univariate analysis, biology, business.industry, Proportional hazards model, Cancer, Retrospective cohort study, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, 030104 developmental biology, 030220 oncology & carcinogenesis, biology.protein, colon cancer, Immunohistochemistry, business
Abstract

Background: Bruton&rsquo, s tyrosine kinase (BTK) is involved in the immune response and its deficiency impairs B cell maturation. We evaluated the expression of a novel BTK isoform, p65BTK, in colorectal cancer (CRC), to identify its impact on survival. Materials and Methods: This retrospective study evaluated 87 consecutive stage III CRC patients treated at the National Cancer Institute of Aviano (1999&ndash, 2017). Multiple specimens were collected and analyzed for staining intensity and percentage of tumor cells positive for p65BTK. Prognostic impact was tested by univariate Cox regression analysis. Results: After a median follow-up of 82.59 months, median disease-free survival (DFS) and overall survival (OS) were 11.67 months and 31.33 months, respectively. Interestingly, 10% of patients did not express p65BTK. For the immunohistochemistry IHC intensity 1, the best cutoff point was 1% of p65BTK positivity, for IHC intensity 2, it was 50%, and for IHC intensity 3, it was 80%. Through univariate analysis, patients with highly expressed p65BTK (IHC intensity 3 and &ge, 80%) were shown to have the worst prognosis in terms of DFS (HR: 6.23, p = 0.005, 95% C.I. 1.75&ndash, 22.79) and OS (HR: 2.54, p = 0.025, 95% C.I. 1.12&ndash, 5.76). Conclusions: p65BTK is frequently expressed in CRC and, if highly expressed, is an unfavourable prognostic factor. However, further confirmation is needed and its potential targeting needs to be studied.

Published
2019

37. Safety and efficacy of non-steroidal anti-inflammatory drugs to reduce ileus after colorectal surgery

Author

Chapman, Sj, Clerc, D, Blanco‐colino, R, Otto, A, Nepogodiev, D, Pagano, G, Schaeff, V, Soares, A, Zaffaroni, G, Žebrák, R, Hodson, J, Glasbey, Jc, Pata, P, Pellino, G, Sgrò, A, Elst, T, Van Straten, S, Knowles, Ch, Borakati, A, Bath, Mf, Yasin, Ih, Mclean, K, Arthur, T, Kovacevic, M, Delibegovic, S, Karamanliev, M, Swamad, M, Paramasivam, R, Martensen, A, Larsen, Hm, Rädeker, L, Frey, Pe, Kechagias, A, Venara, A, Duchalais, E, Ioannidis, A, Pata, F, Pasquali, S, Simioni, A, Farina, V, Podda, M, Lorenzon, L, Jakubauskas, M, Elst, Tr, Chu, M, Fagan, Pvb, Wells, Ci, Alagoa João, A, Juloski, J, Ciubotaru, C, Popescu, S, Yanishev, A, Lee, S, Ozkan, Bb, Yagız Sen, A, Aktas, Mk, Baki, Be, Yüksek, B, Kamarajah, S, Khaw, Ra, Mills, E, Goodson, R, Thakral, N, Ablett, Ad, Adra, M, Kwek, I, Khan, Sm, Quinn, P, Manley, Lr, Badran, A, Ramjeeawon, A, Campbell, A, Tan, Hl, Rye, Ds, Rajaraman, N, Norman, Jg, Vutipongsatorn, K, Solomou, G, Akhbari, M, Ali, A, Murray, V, Baker, Dm, Brandao, Bd, Stainer, B, Thavayogan, R, Jones, D, Onafowokan, Oo, Gharooni, A, Dabab, N, Carlton‐carew, S, Kungwengwe, G, Gabriel, M, Sewart, E, Shortland, Tc, Lawday, S, Pockney, P, Dawson, A, Brumfitt, Cd, Stewart, P, Ng, B, Luong, Jk, Ivanov, V, Borisova, A, Neykov, V, Kunčarová, K, Kološová, B, Antonova, T, Farkašová, M, Harbjerg, Jl, Brandsborg, S, Brinck, S, Kjaer, Md, Mark‐christensen, A, Unbehaun, Kp, Dalsgaard, P, Lycke, Kd, Lenaoures, P, Brigand, C, Dumange, E, Gout, M, Moehwald, C, Prem, M, Alhalabi, O, Sliwinski, S, Krupp, J, Gablenz, E, Schmitzer, L, Kopp, A, Steinle, J, Gsenger, J, Pohl, Lj, Riccardi, M, Christodoulou, Im, Konstantinidis, M, Machairas, N, Zoikas, A, Balalis, D, Manatakis, Dk, Aguilera, Ml, Marano, L, Fleres, F, Lovisetto, F, Sasia, D, Segalini, E, Pata, G, Lucchi, A, Sagnotta, A, Campagnaro, T, Petrelli, F, Gallo, G, Papandrea, M, Testa, V, Sinibaldi, G, Di Candido, F, Colombo, F, Perrone, G, Aresu, S, Biancafarina, A, Canonico, G, Pagnanelli, M, Curletti, G, Bini, R, Manzoni Garberini, A, Impellizzeri, H, Cillara, N, Tutino, R, Picciariello, A, Coletta, D, Savino, G, Ferrara, F, Tamini, N, Talamo, G, Parini, D, Giamundo, P, lo Conte, A, Ripetti, V, Pesce, A, Menduni, N, Giudicissi, R, Goldin, E, Rega, D, Belli, A, Andriola, V, Gordini, L, Foppa, C, Piccolo, G, Birindelli, A, Ferrari, C, Ballarini, Z, Tirelli, F, Milone, M, De Rosa, M, Pipitone Federico, Ns, Molteni, B, Tilocca, Pl, Sancini, G, Piozzi, Gn, Lauretta, A, Poillucci, G, Mulas, S, Simcikas, D, Portelli, L, Wijnbergen, Jwm, Dinger, Tl, Doesschate, Sfh, Dalen, Ashm, Bos, Dd, Hansmann, M, Medina Feliz, J, Kuiper, Sz, Abdulrahman, Z, Pruijssers, Sr, Farik, S, Elliott, Bm, Geneta, Vp, Wilton, S, Kandelaki, H, Peng, Sl, Campbell, S, Lim, Yk, Yassaie, Ss, Murray, M, Haran, C, Tan, J, Castro, J, Laranjeira, A, Catarino, S, Neves‐marques, C, Correia, Jg, Vieira, Bn, Quintela, Ac, Serra, Ml, Maciel, J, Cunha, M, Aparício, Dj, Neves, J, Azevedo, J, Romano, M, Eiró, F, Romano, J, Monteiro, C, Claro, M, Almeida, Mr, Peyroteo, M, Machado, Nd, Capote, H, Ferreira, M, Sousa, X, Devesa, H, Cavadas, D, Guerreiro, I, Costa, M, Salman, M, English, C, Mohammed, N, Litvin, A, Ćuk, Vv, Mészárosová, K, Jaich, R, De Lima, H, Brooks, S, Marx, M, Nshalati Salvation, M, Blaser, B, Piazza, G, Gagliardi, B, Serin, H, Yurdaor, Ss, Arslan, E, Kopac, O, Uyanik, A, Ozmen, Bb, Tiftik, E, Aksoy, B, Yalcinkaya, A, Ozoglu, F, Kocer, Md, Bilicen, G, Cinar, En, Uslu, Ö, Kaya, Y, Wong, J, Farhan‐alanie, Mmh, Suresh, G, Asif, A, Finch, Bj, Bhahirathan, Y, Herron, J, Yi Tew, Z, Obukofe, R, Russell, C, Suchett‐kay, I, Netke, T, Williams, L, Kisiel, A, Liu, Fy, Claireaux, H, James, P, Mondal, A, Kalderon, R, Nadama, Hh, Al‐saraff, Z, Tam, Jph, Powell‐chandler, A, Wood, F, Gorgievska, Rebecca, Ragavoodoo, A, Thakrar, C, Rojoa, D, Palmer, C, Davidson, K, Giacci, L, Hale, J, Gan, Fw, Makin‐taylor, R, Hey, Cy, Toh, C, Findlay, Jm, Griffiths, N, Ganesananthan, S, Jasionowska, S, Poustie, M, Wong, C, Turner, T, Pyc, W, Sloper, W, Warner, C, Coey, J, Mason, D, Sait, S, Kowal, M, Owen, M, Saiyed, A, Ashworth, I, Akbari, K, Curran, M, Martin, P, Parker, D, Kwok, K, Lye, C, Ghaly, M, Sammour, T, Lewis, D, Mundasad, R, Wilkes, A, Ctercteko, G, Maslyankov, S, Dimov, R, Iliev, S, Dimitrov, D, Marek, F, Örhalmi, J, Skalický, P, Skalický, T, Chrz, K, Christensen, P, Worsøe, J, Kristensen, Es, Emmertsen, Kj, Loeve, Us, Mihaljevic, Al, Herrle, F, Konstantinidis, Km, Korkolis, D, Karanikas, I, Vincenti, L, Anania, G, Borghi, F, Agresta, F, Maretto, I, Parisi, A, Bucci, L, De Palma, G, Guglielmi, A, Cucinotta, E, La Torre, F, Cianchi, F, Guerrieri, M, Trompetto, M, Persiani, R, Micheletto, G, Cantafio, S, Ronconi, M, Bisagni, Pag, De Prizio, M, Franceschi, A, Galleano, R, Cavallini, M, Brescia, A, D'Ambra, L, Benevento, A, Niolu, P, Calgaro, M, Colangelo, E, Grottola, T, Altomare, Df, Puleo, S, Salamone, G, Pietrabissa, A, Poggioli, G, Erdas, E, Ottonello, R, Tonini, V, Selvaggi, F, Sammarco, G, Ceccarelli, G., De Nisco, C, Surgo, D, Taglietti, L., Ozolins, A, Sivinš, A, Poskus, T, Psaila, J, Bemelman, Wa, Graat, Lj, Langenhoff, B, Wijnhoven, Bpl, Ven, Ahw, Poelman, M, Stassen, Lps, Slooter, G, Acherman, Yiz, Hoff, C, Gerhards, Mf, Stommel, Mwj, Hazebroek, Ej, Geloven, Aaw, Schasfoort, Ra, Leeuwen, Bl, Tuynman, Jb, Tilburg, Mwa, Boerma, Eg, Sharma, P, Jenkins, B, Bissett, Ip, Herd, A, Gordon, A, Vernon, D, Omundsen, M, Ly, J, Reddy, A, Bonnet, G, Harmston, C, Morales, M, Francisco, V, Costa, S, Manso, A, Amorim, E, Pereira, J, Cardoso, J, Ourô, S, Caratão, M, Nascimento, C, Ribeiro da Silva, B, Taranu, V, Dias, R, Mendes, J, Allen, M, Silva, A, Carlos, S, Barbosa, E, Carneiro, C, Ramos, L, Lencastre, L, Martins, R, Silva‐vaz, P, Ridgway, Pf, Mcnamara, Da, Cahill, R, Hogan, A, Larkin, J, O'Connell, Pr, Negoi, I, Abelevich, A, Ćuk, Vm, Vician, M, Ede, C, Sardiwalla, I, Mulira, S, Montwedi, D, Oyomno, M, Hübner, M, Petermann, D, Sauvain, Mo, Ozben, V, Geçim, Ie, Disçi, E, Rencuzogullari, A, Kurt, A, Bisgin, T, Pehlivan, M, Isik, A, Onur, E, Leventoglu, S, Haksal, Mc, Erturk, Ms, Keskin, M, Guner, A, Tutcu Sahin, S, Ozbalci, Gs, Pergel, A, Albayrak, D, Bruce, D, Fearnhead, N, Arthur, J, Harron, M, Beattie, G, Titu, L, Saunders, M, Phillips, J, Dindyal, S, Cresswell, B, Gercek, Y, Lee, J, Linn, T, Faulkner, G, Lockwood, S, Rees, J, Charalabopoulos, A, Campbell, B, Kontovounisios, C, Amarnath, T, Johnson, M, Epanomeritakis, E, Vigs, S, Nastro, P, Gilliam, A, Smolarek, S, Wilson, T, Orbell, J, Mcintyre, R, Agarwal, T, Hainsworth, P, Patel, P, Vijay, J, Liu, B, Dhruva Rao, P, Roxburgh, C, Vipond, M, Youssef, H, Thorn, C, Schizas, A, Denley, S, Bowley, D, Das, K, Cuming, T, Saha, A, Chung, L, Pitt, J, Davis, P, Jones, O, Taylor, M, Bhargava, A, Haji, A, Watson, N, Bloom, I, Singh, B, Norwood, M, Gurjar, S, Stylianides, N, Mirza, S, Evans, M, Williams, G, Patil, P, Hernon, J, Finch, G, Green, S, Chapple, K, Fafemi, O, Warusavitarne, J, Samee, A, Carden, C, Ong, L, Verma, K, Joseph, A, Rawat, N, Pinkney, T, Oke, O, Glen, P, Maxwell‐armstrong, C, Oliphant, R, Garner, J, Moug, Sj, Middleton, S, Lund, Jn, Smart, Nj, Osborn, G, Moore, T, Raymond, T, Hany, Ts, Clarke, R, Khera, G, Brady, R, Sellahewa, C, Mason, C, Torrance, A, Lasithiotakis, K, Knight, J, Pullybank, A, Ainsworth, P, Reid, F, Ramwell, A, Maslekar, S, George, R, Skull, A, Holtham, S, Muhammad, K, Lal, R, Varcada, M, Smith, Fm, Howlader, M, Defriend, D, Kirk, S, Richards, T, Evans, C, Borg, C, Telford, K, Sarfraz, N, Busby, K, Hollingshead, J, Speake, D, Pawa, N, West, D, Chadwick, M, Komolafe, O, Richardson, S, Thornton, M, Goede, A, Osborne, C, Bandyopadhyay, D, Foong, J, Lee, Yj, Liebenberg, P, Mijalkov, D, Wells, A, Bull, N, Ajmera, A, Warburton, T, Morgan, S, Mahmoud, A, Schachtel, M, Mikhail, B, Fomin, I, Mekaeil, B, Taylor, N, Stevenson, C, Drane, A, Pahalawatta, U, Lai, Lt, Debiasio, A, Jun, Hjs, Hengpoonthana, R, Mendis, Dm, Robb, Pm, Lee, Hj, Wyche, Aab, Davis, Lt, Chrimes, A, Agarwal, A, Zhao, J, Williams, S, Jayalath, Jmsn, Khor, S, Muddasani, T, Childs, S, Ridgway, S, Blefari, Nda, Tam, H, Puchalski, N, Ngai, C, Mackenzie, J, Johnson, N, Holmes, M, Zuzek, R, Saluja, T, Gould, T, Goh, Yk, Selvaraj, T, Beh, Yz, Dudi‐venkata, Nn, Horne, D, Borrow, Jl, Campbell, C, Cousins, G, Jackson, L, Maheepala, K, Zhao, S, Holden, E, Tutt, L, Thompson, B, Collins, H, Louie, F, Buckland, B, Smith, D, Chong, C, Chua, Th, Nayak, C, Redmond, J, Tan, Rr, Gramlick, M, Teh, Js, Sy, Ng, Britten‐jones, P, Mohd Rosli, R, Pham, Hdv, Jegathees, T, Coulter‐nile, Smcj, Gosselink, Mp, Wang, Yl, Maciaszek, M, Chrapko, Ps, Nair, A, Thirugnanasundralingam, V, Muir, K, Salibasic, M, Pavlov, V, Paycheva, T, Lyulenina, E, Kolev, N, Nguen, D, Mitkov, Y, Mitkov, E, Vladova, P, Dimitrov, V, Hussain, M, Gabarski, A, Ivanov, T, Yotsov, T, Ilieva, I, Akisheva, A, Shoshkova, M, Nawaz, E, Feradova, H, Mladenov, T, Jozaf, V, Klail, T, Pös, M, Adel, A, Sotona, O, Bartoš, M, Amjad, T, Malý, O, Berec, S, Hanušová, M, Hurný, M, Riško, J, Ludvik, M, Stercz, M, Treskoň, R, Pospíšil, M, Hlaváčová, L, Tomanová, D, Chodora, S, Houdek, O, Novický, R, Sobotková, K, Cha, S, šuta Kimle, K, Jirankova, K, Bujda, M, Paclík, A, Trap, A, Jürgens‐lahnstein, J, Storm, M, Damgaard, I, Olawi, F, Ehlem, F, Raos, M, Kristensen, Fp, Bønnerup, K, Amiri, S, Enevoldsen, M, Højgaard Pedersen, J, Jepsen, Bn, Hillgaard, Tk, Erichsen, Sb, Nielsen, Cv, Madsen, Cp, Bjerke, J, Skejø, Cd, Aabling, Rr, Sørensen, Js, Turunen, A, Katunin, J, Niskakangas, M, Vignaud, T, Frey, S, Ricolleau, C, Chanut, F, Magnin, J, Seiboldt, T, Beck, L, Zamzow, K, Betge, F, Poncelet, A, Truant, M, Hauschild, H, Neugebauer, N, Schöning, L, Simon, S CS, Galata, C, Karampinis, I, Thäwel, T, Seckler, Am, Kerem, C, Durdevic, S, Antonakopoulos, F, Mathioulaki, A, Chrysoheris, P, Athanasopoulos, Pg, Kalles, V, Spyrou, I, Barkolias, C, Paspala, A, Papaconstantinou, D, Spartalis, E, Arkadopoulos, N, Prodromidou, A, Garoufalia, Z, Mendez, D, 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Leathes J., Philip Rajathasan T., Jeddy H., Kyaw H.A., Wong N., Karelia S., Clements J.M., Rainey M., Joshi N., Rahman A., Gallagher M., Rebuffa N., Abdelgalil R., Siaw Yen Lai R., Laurence N., Thomas S., Green C., Frostick R., Khera R., Povey M., Wong H.L., McCusker C., Hlukha L., Pike G., Kamel F., Thakkar R., Donaldson C., Sequeira Campos M., Armitage M.N., Hussain A.S., Hardy B., Hassan Serry M.Y., Bradbury M., Osunronbi T., Tam L.Y.C., Khanan Kaabneh A., Lawther J., Fisher P., Tribedi T., Moosa A., Ramdin A., Goble M., Downs E., Wheldon L., Baggus E., Mandal A., Nayeem A., Ahmed S., Fradley W., Wilson C., Gallagher S., Criswell T., Ward J., Mukkavilli A., Stubbs B., Fordyce W., Suchdev N., Wei Lim S., Sookramanien S.R., Chan A., Bointas G., Paul M., Ward K.L., Bagnall M., Pherwani S.A., Wang K., Mitchell L., Heyworth J., Ayyar S., Polson R., Mackenzie E., Doyle N., Habib Z., Zardab M., Sartaj F., Farooq H., Tabibi M., Drury D.J., James S.J., Barnett R., Teasdale A.B., Richardson 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al-Ausi M., Jovaisaite A., Shah S.M., Khalid N., Gutmann D., Davison S., Alame Y.J., Syed L., Owen W.J., Ahsan S.D., Anthony-Uzoeto U., Macleod Hall C., Zheng S., Wynter K., James C., Sapre D., Ghosh R., Baird J., Cockburn L., Blackwood O., Simpson W., Jeong S., Bishop S., Bate R., Hobson C., Adam A.H., Redclift C., Do J., Adeleye O., Poli F., Batterham A., Brown S., Parekh J.N., Clay W., Pieri K., Jackson A., Saxena A., Gurung B., Oyebola T., O'Brien F., Djeugam B., Gardezi S., Ul-Hasan S., Martin-Hernandez M.P., Sisley M., Modi S., Antakia R., Elbayouk A., Soh Y.J., Mather J., Yusuf Z., Al-Sarraf Z., Naja M., Rassool S.B., Convill J., Nikookam Y., Warsame A., Pace C., Kiandee M., Ridwan R., Carey C., Hirri F., McMillan M.J.A., Ling J.J., Pendelbury L., Kerimzade K., Tang A., Howard E.O., Humayun S., Wadsworth O.J., Tan K., Abdelhameed F., Haglund C., Radnaeva I., Hu N., Rambhatla S., Waldron D., Madahar P., Malik S., Meney L.C., Ibrahim I., Kang C.K., Chiu J.Z.J., Livie V., Ibrahim 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S., Rajaraman, N., Norman, J. G., Vutipongsatorn, K., Solomou, G., Akhbari, M., Ali, A., Murray, V., Baker, D. M., Brandao, B. D., Stainer, B., Thavayogan, R., Jones, D., Onafowokan, O. O., Gharooni, A., Dabab, N., Carlton-Carew, S., Kungwengwe, G., Gabriel, M., Sewart, E., Shortland, T. C., Lawday, S., Pockney, P., Dawson, A., Brumfitt, C. D., Stewart, P., Ng, B., Luong, J. K., Ivanov, V., Borisova, A., Neykov, V., Kuncarova, K., Kolosova, B., Antonova, T., Farkasova, M., Harbjerg, J. L., Brandsborg, S., Brinck, S., Kjaer, M. D., Mark-Christensen, A., Unbehaun, K. P., Dalsgaard, P., Lycke, K. D., Lenaoures, P., Brigand, C., Dumange, E., Gout, M., Moehwald, C., Prem, M., Alhalabi, O., Sliwinski, S., Krupp, J., Gablenz, E., Schmitzer, L., Kopp, A., Steinle, J., Gsenger, J., Pohl, L. J., Riccardi, M., Christodoulou, I. M., Konstantinidis, M., Machairas, N., Zoikas, A., Balalis, D., Manatakis, D. K., Aguilera, M. L., Marano, L., Fleres, F., Lovisetto, F., Sasia, D., Segalini, E., Pata, G., Lucchi, A., Sagnotta, A., Campagnaro, T., Petrelli, F., Gallo, G., Papandrea, M., Testa, V., Sinibaldi, G., Di Candido, F., Colombo, F., Perrone, G., Aresu, S., Biancafarina, A., Canonico, G., Pagnanelli, M., Curletti, G., Bini, R., de Manzoni Garberini, A., Impellizzeri, H., Cillara, N., Tutino, R., Picciariello, A., Coletta, D., Savino, G., Ferrara, F., Tamini, N., Talamo, G., Parini, D., Giamundo, P., lo Conte, A., Ripetti, V., Pesce, A., Menduni, N., Giudicissi, R., Goldin, E., Rega, D., Belli, A., Andriola, V., Gordini, L., Foppa, C., Piccolo, G., Birindelli, A., Ferrari, C., Ballarini, Z., Tirelli, F., Milone, M., De Rosa, M., Pipitone Federico, N. S., Molteni, B., Tilocca, P. L., Sancini, G., Piozzi, G. N., Lauretta, A., Poillucci, G., Mulas, S., Simcikas, D., Portelli, L., van Wijnbergen, J. W. M., Dinger, T. L., ten Doesschate, S. F. H., van Dalen, A. S. H. M., van den Bos, D. D., Hansmann, M., Medina Feliz, J., Kuiper, S. Z., Abdulrahman, Z., Pruijssers, S. R., Farik, S., Elliott, B. M., Geneta, V. P., Wilton, S., Kandelaki, H., Peng, S. L., Campbell, S., Lim, Y. K., Yassaie, S. S., Murray, M., Haran, C., Tan, J., Castro, J., Laranjeira, A., Catarino, S., Neves-Marques, C., Correia, J. G., Vieira, B. N., Quintela, A. C., Serra, M. L., Maciel, J., Cunha, M., Aparicio, D. J., Neves, J., Azevedo, J., Romano, M., Eiro, F., Romano, J., Monteiro, C., Claro, M., Almeida, M. R., Peyroteo, M., Machado, N. D., Capote, H., Ferreira, M., Sousa, X., Devesa, H., Cavadas, D., Guerreiro, I., Costa, M., Salman, M., English, C., Mohammed, N., Litvin, A., Cuk, V. V., Meszarosova, K., Jaich, R., De Lima, H., Brooks, S., Marx, M., Nshalati Salvation, M., Blaser, B., Piazza, G., Gagliardi, B., Serin, H., Yurdaor, S. S., Arslan, E., Kopac, O., Uyanik, A., Ozmen, B. B., Tiftik, E., Aksoy, B., Yalcinkaya, A., Ozoglu, F., Kocer, M. D., Bilicen, G., Cinar, E. N., Uslu, O., Kaya, Y., Wong, J., Farhan-Alanie, M. M. H., Suresh, G., Asif, A., Finch, B. J., Bhahirathan, Y., Herron, J., Yi Tew, Z., Obukofe, R., Russell, C., Suchett-Kay, I., Netke, T., Williams, L., Kisiel, A., Liu, F. Y., Claireaux, H., James, P., Mondal, A., Kalderon, R., Nadama, H. H., Al-Saraff, Z., Tam, J. P. H., Powell-Chandler, A., Wood, F., Gorgievska, R., Ragavoodoo, A., Thakrar, C., Rojoa, D., Palmer, C., Davidson, K., Giacci, L., Hale, J., Gan, F. W., Makin-Taylor, R., Hey, C. Y., Toh, C., Findlay, J. 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G., De Prizio, M., Franceschi, A., Galleano, R., Cavallini, M., Brescia, A., D'Ambra, L., Benevento, A., Niolu, P., Calgaro, M., Colangelo, E., Grottola, T., Altomare, D. F., Puleo, S., Salamone, G., Pietrabissa, A., Poggioli, G., Erdas, E., Ottonello, R., Tonini, V., Selvaggi, F., Sammarco, G., Ceccarelli, G., De Nisco, C., Surgo, D., Taglietti, L., Ozolins, A., Sivins, A., Poskus, T., Psaila, J., Bemelman, W. A., Graat, L. J., Langenhoff, B., Wijnhoven, B. P. L., van de Ven, A. H. W., Poelman, M., Stassen, L. P. S., Slooter, G., Acherman, Y. I. Z., Hoff, C., Gerhards, M. F., Stommel, M. W. J., Hazebroek, E. J., van Geloven, A. A. W., Schasfoort, R. A., van Leeuwen, B. L., Tuynman, J. B., van Tilburg, M. W. A., Boerma, E. G., Sharma, P., Jenkins, B., Bissett, I. P., Herd, A., Gordon, A., Vernon, D., Omundsen, M., Ly, J., Reddy, A., Bonnet, G., Harmston, C., Morales, M., Francis, A. 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S., Pergel, A., Albayrak, D., Bruce, D., Fearnhead, N., Arthur, J., Harron, M., Beattie, G., Titu, L., Saunders, M., Phillips, J., Dindyal, S., Cresswell, B., Gercek, Y., Lee, J., Linn, T., Faulkner, G., Lockwood, S., Rees, J., Charalabopoulos, A., Campbell, B., Kontovounisios, C., Amarnath, T., Johnson, M., Epanomeritakis, E., Vigs, S., Nastro, P., Gilliam, A., Smolarek, S., Wilson, T., Orbell, J., Mcintyre, R., Agarwal, A., Hainsworth, P., Patel, P., Vijay, J., Liu, B., Dhruva Rao, P., Roxburgh, C., Vipond, M., Youssef, H., Thorn, C., Schizas, A., Denley, S., Bowley, D., Das, K., Cuming, T., Saha, A., Chung, L., Pitt, J., Davis, P., Jones, O., Taylor, M., Bhargava, A., Haji, A., Watson, N., Bloom, I., Singh, B., Norwood, M., Gurjar, S., Stylianides, N., Mirza, S., Evans, M., Williams, G., Patil, P., Hernon, J., Finch, G., Green, S., Chapple, K., Fafemi, O., Warusavitarne, J., Samee, A., Carden, C., Ong, L., Verma, K., Joseph, A., Rawat, N., Pinkney, T., Oke, O., Glen, P., Maxwell-Armstrong, C., Oliphant, R., Garner, J., Moug, S. 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T., Chrimes, A., Zhao, J., Williams, S., Jayalath, J. M. S. N., Khor, S., Muddasani, T., Childs, S., Ridgway, S., Blefari, N. D. A., Tam, H., Puchalski, N., Ngai, C., Mackenzie, J., Johnson, N., Holmes, M., Zuzek, R., Saluja, T., Gould, T., Goh, Y. K., Selvaraj, T., Beh, Y. Z., Dudi-Venkata, N. N., Horne, D., Borrow, J. L., Campbell, C., Cousins, G., Jackson, L., Maheepala, K., Zhao, S., Holden, E., Tutt, L., Thompson, B., Collins, H., Louie, F., Buckland, B., Smith, D., Chong, C., Chua, T. H., Nayak, C., Redmond, J., Tan, R. R., Gramlick, M., Teh, J. S., Ng, S. Y., Britten-Jones, P., Mohd Rosli, R., Pham, H. D. V., Jegathees, T., Coulter-Nile, S. M. C. J., Gosselink, M. P., Wang, Y. L., Maciaszek, M., Chrapko, P. S., Nair, A., Thirugnanasundralingam, V., Muir, K., Salibasic, M., Pavlov, V., Paycheva, T., Lyulenina, E., Kolev, N., Nguen, D., Mitkov, Y., Mitkov, E., Vladova, P., Dimitrov, V., Hussain, M., Gabarski, A., Ivanov, T., Yotsov, T., Ilieva, I., Akisheva, A., Shoshkova, M., Nawaz, E., Feradova, H., Mladenov, T., Jozaf, V., Klail, T., Pos, M., Adel, A., Sotona, O., Bartos, M., Amjad, T., Maly, O., Berec, S., Hanusova, M., Hurny, M., Risko, J., Ludvik, M., Stercz, M., Treskon, R., Pospisil, M., Hlavacova, L., Tomanova, D., Chodora, S., Houdek, O., Novicky, R., Sobotkova, K., Cha, S., suta Kimle, K., Jirankova, K., Bujda, M., Paclik, A., Trap, A., Jurgens-Lahnstein, J., Storm, M., Damgaard, I., Olawi, F., Ehlem, F., Raos, M., Kristensen, F. P., Bonnerup, K., Amiri, S., Enevoldsen, M., Hojgaard Pedersen, J., Jepsen, B. N., Hillgaard, T. K., Erichsen, S. B., Nielsen, C. V., Madsen, C. P., Bjerke, J., Skejo, C. D., Aabling, R. R., Sorensen, J. S., Turunen, A., Katunin, J., Niskakangas, M., Vignaud, T., Frey, S., Ricolleau, C., Chanut, F., Magnin, J., Seiboldt, T., Beck, L., Zamzow, K., Betge, F., Poncelet, A., Truant, M., Hauschild, H., Neugebauer, N., Schoning, L., Simon, S. C. S., Galata, C., Karampinis, I., Thawel, T., Seckler, A. M., Kerem, C., Durdevic, S., Antonakopoulos, F., Mathioulaki, A., Chrysoheris, P., Athanasopoulos, P. G., Kalles, V., Spyrou, I., Barkolias, C., Paspala, A., Papaconstantinou, D., Spartalis, E., Arkadopoulos, N., Prodromidou, A., Garoufalia, Z., Mendez, D., Rosales, J., Flores, M., Garcia, M., Garcia, A., Noriega, Z., Torselli, D., Rodriguez, J., Lafranceschina, S., Artioli, E., Giaccari, S., Nevoso, V., Schimera, A., Marino, S., Geretto, P., Pellegrino, L., Borghi, B., Marano, A., Corino, C., Cannata, G., Giuffrida, M. C., Landra, F., Ongaro, D., Baronio, G., Raimondo, S., Casiraghi, S., Salvadori, R., Finotti, E., Ciccioli, E., Galgano, A., Zuin, M., Bettella, A., Barina, A., Vendramin, E., Palano, G., Schiavone, D., Di Cintio, A., Gemini, A., Trastulli, S., De Luca, M., Desiderio, J., Gubbiotti, F., Cigognini, M., Maffioli, A., Colombo, S., Bondurri, A., Sampietro, G., Foschi, D., Manigrasso, M., Danzi, M., Amato, R., Anastasio, L., Mastella, F., Basile, R., Peltrini, R., Marra, E., Luglio, G., Giglio, M., Anoldo, P., Vertaldi, S., Grimaldi, L., Tammaro, N., Pedrazzani, C., Turri, G., Lazzarini, E., Conti, C., Vulcano, I., Bertilone, E., Pintabona, G., Viscosi, F., Cerasari, S., Galiffa, G., Lapolla, P., Del Basso, C., Cirillo, B., De Toma, G., Fazzi, K., Bini, S., Coratti, F., Montanelli, P., Grandi, S., Nelli, T., Ben Khaled, N., Cammelli, F., Ferrini, E., Billo, M. E., Marrosu, A. G., Scognamillo, F., Pala, C., Attene, F., Carboni, L., Ruggiu, M. W., Gabbas, G., Marziali, I., Mazzocato, S., Vergari, R., Piazzai, F., Kubolli, I., Aggiusti, A., Paolucci, A., Ortenzi, M., Olivieri, M., Belluco, C., Antona, A. D., Basso, S., Morino, M., Mistrangelo, M., Clerico, G., De Santi, G., Bitonti, M. F., Frattalone, M., Fico, V., Santullo, F., Belia, F., Spinelli, A., Marco, M., Bevilacqua, M., Tringali, D., Bevilacqua, E., Panizzo, V., La Manna, V., Migliore, G., Aversano, A., Fares Bucci, A., Marino, F., Carbone, F., Incollingo, P., Romano, F. M., Zalla, T., Baraghini, M., Romoli, L., Calussi, M., Vellei, S., Genzano, C., Feroci, F., Vita, M., Barberis, A., Serra, D., Grassia, M., Romelli, M., Ruggiero, S., Percassi, A., Magri Piccinini, A., Monti, M., Magnoli, M., Romano, S., Gaetano, P., Pilotta, F., Baldassarre, L., Bonati, E., Saba, A., Moretto, G., Bacchion, M., Casaril, A., Inama, M., Creciun, M., Stella, M., Gobatti, D., Angelini, M., Andolfi, E., Miranda, E., Scricciolo, M., Provenza, G., Cavallina, G., Frezza, B., Fontani, A., Malatesti, R., Pellicano, G. A., Anania, M., Pulighe, F., Cruccu, A., Murru, M. L., Massaiu, C., Balestra, F., Pazzona, M., Giannella, A., Santangelo, M., Frangella, F., Magagnano, D., Liberatore, P., Brenna, R., Giani, A., Tirotta, F., Famularo, S., Angrisani, M., Ceresoli, M., Rondelli, F., Angelucci, G. P., Scaramuzzo, R., Larcinese, A., Fioriti, C., Picone, E., Nardi, M., Castagnoli, G., Bartoli, A., Bellochi, R., Spaziani, A., Conti, D., Poponesi, V., Trippetti, M., Amicucci, S., Tazza, G., Procacci, P., Giovannini, F., Basile, E., Caristo, G., De Nardi, P., Rosati, R., Marcocci, G., Vignali, A., Malerba, M., Percivale, A., Ghazouani, O., Reggiani, L., Spirito, C., Moschetta, G., Cosmi, F., Romeo, G., Gasparrini, M., Sucameli, F., Gennai, A., Moggia, E., Bianchi, C., Bonfante, P., Macina, S., Feleppa, C., Imperatore, M., Tenconi, S. M., Rausei, S., Maioli, D., Marchionini, V., Sparta, C., Mura, F. A., Barmina, M., Lorettu, A., Rettaroli, C., Mastino, G., Ruggiu, G. V., Mura, G. A., Perrone, B. A., De Angelis, M., Mereu, A., Adamo, V., Bianco, C., Ricciardiello, M., Campanaro, C., Panaccio, P., Esposito, L. 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G., Galvao, D., Mora, A., Bettencourt, R., Costa, F., Gil, I., Morgado, J., Monica, I., Oliveira, S., Ribeiro, H., Guimaraes, N., Duarte, M., Miranda, J., Martins, S. F., Parreira, R., Faustino, A., Medeiros, N., Castro, R., Soares, B., Resendes, M., Almeida, P., Cruz, A., Vaz Pinto, G., Sousa, D., Costa Santos, D., Silva, F., Fialho, G., Reia, M., Pratas, N., Costa, C., Costa, J., Morais, S., Machado, A., Horta, V., Rocha-Melo, M., Patricio, J., Pereira, M., Lima, R., Cinza, A. M., Oliveira, J., Velez, C., Borges, F., Simoes, J., Botelho, P., Cismasiu, B., Alves, D., Dias, B., Goncalves, J. P., Valente, P., Freire, L., Saraiva, R., Moreira, M., Fragoso, M., Guimaraes, J., Cruz, G., Ribeiro, J., Borges da Ponte, I., Almeida, S., Martins, A. R., Louro, T., Morgado, M., Ferreira, A. S., Alves, M., Oliveira, N., Lerias, R., Estalagem, I., Botelho, C., Bartolo, J., Fidalgo Antunes, C., Cabral, F., Brito Silva, F., Dias Matos, A., Santos, M., Cunha, R., Sousa, M., Canotilho, R., Correia, A. M., Martins, P. C., Jardim, J. A. M., Domingos, S. P., Baiao, J. M., Rocha, B. S., Lopes, N. M. R. O., Jordao, D. M., Angelo, M. D., Caroco, T., Gomes, J. R., Monteiro, R. G., Varghese, S., Boyle, E., Aljohmani, L., Alexander, J., Graziadei, V., Mccaughey, C., Jain, A., Ramanayake, H., Sabnani, R., Colon, L. F., Bansal, N., Stephens, I., Tan, R., Sharma, S., Doherty, G., Fenn, S., Mulhare, E., Walsh, M., Leavey, C., Costigan, O., Griffin, S., Dockry, E., Khogali, E., Aly, A. K., Mcphedran, R., O'Gorman, D., Vermeulen, D., Dervan, L., Kang, S. J., Dixon, O., Morrissey, E., Compton, M., Pentony, A. R., Piong, C. L., Nossier, R., Hanna, J., Sabir, K., Eow, S. Y., Ladak, N., Boersma, D., Kamath, P. J., Soh, T. B. W., Dyer, A. H., Chee, S. Y., Tan, I. X. H., Kelliher, A., Adeusi, L., Howarth, N., Mccawley, N., O'Neill, A., Jones, M. R., Saleh, R., Singh, A., Senaratne, R., Kakodkar, P., Subramanian, I., Al-Salihi, A., Vyas, V., Vedadi, A., Popescu, S. S., Piras, K., Ciubotaru, C. I., Romanova, E., Ponomarev, N., Savchenko, A., Luzan, R., Lutovinova, E., Gavrilina, A., Barkovskaya, A., Kudelkina, N., Topchubaev, D., Radulovic, R., Milosevic, K., Bojicic, J., Gencic, M., Jankovic, U., Zubowicz, M., Suchan, P. K., Gerstmeier, J., Brazitikou, E., Fytrou, E., Celik, M., Dubovsky, M., Schmalenbeck, J., Sautter, S. C., Ceyran, H., Fitchat, N., Mathebula, S., Chauke, J., Mculu, W., Ngwenya, Z., Withey, K., Piperidis, A., Toyi, Y., Nicolaides, A., Jaffer, T., Sparke, A., Van Staden, N., Mcduling, C. R., Claassen, L., Kruger, C., Weyers, J., Lecler, J., Mignon, G., Vanoni, A., Henkens, A., Jarrar, G., Odovic, M., Willemin, M., Milliet, O., Hahnloser, D., Demartines, N., Teixeira, H., Pittet, O., Haller, M. 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M., Foulkes, A., Jones, N., Pillai, S., Khoury, G., Powell, T., Maleyko, I., Sangheli, A., Ransome, M., Isse, M., Aromolaran, O., Bholah, H., Anbarasan, J., Rehman, S., Hu, E., Timms, S., Reynolds, W., Hotchkies, A., Misra, V., Theocharidou, L., Malik, T., Janmohamed, I., Carhart, B., Khan, A., Hullait, R., Rylance, A., Butt, S., Leathes, J., Philip Rajathasan, T., Jeddy, H., Kyaw, H. A., Wong, N., Karelia, S., Clements, J. M., Rainey, M., Joshi, N., Rahman, A., Gallagher, M., Rebuffa, N., Abdelgalil, R., Siaw Yen Lai, R., Laurence, N., Thomas, S., Green, C., Frostick, R., Khera, R., Povey, M., Wong, H. L., Mccusker, C., Hlukha, L., Pike, G., Kamel, F., Thakkar, R., Donaldson, C., Sequeira Campos, M., Armitage, M. N., Hussain, A. S., Hardy, B., Hassan Serry, M. Y., Bradbury, M., Osunronbi, T., Tam, L. Y. C., Khanan Kaabneh, A., Lawther, J., Fisher, P., Tribedi, T., Moosa, A., Ramdin, A., Goble, M., Downs, E., Wheldon, L., Baggus, E., Mandal, A., Nayeem, A., Ahmed, S., Fradley, W., Wilson, C., Gallagher, S., Criswell, T., Ward, J., Mukkavilli, A., Stubbs, B., Fordyce, W., Suchdev, N., Wei Lim, S., Sookramanien, S. R., Chan, A., Bointas, G., Paul, M., Ward, K. L., Bagnall, M., Pherwani, S. A., Wang, K., Mitchell, L., Heyworth, J., Ayyar, S., Polson, R., Mackenzie, E., Doyle, N., Habib, Z., Zardab, M., Sartaj, F., Farooq, H., Tabibi, M., Drury, D. J., James, S. J., Barnett, R., Teasdale, A. B., Richardson, E. T. J., Thomas, D. A., Williams, R. L., Najabat-Lattif, H. F., Cahya, E., Lou, G., Coyle, M., Homyer, K., Zhu, L. Y., Woods, M., Chang, J., O'Callaghan, H., Suchett-Kaye, I., Mihailidis, T. H., Alawattegama, H., Seite, E., Barrett, A., Riordan, E., Lam, W., Dowdeswell, M., Mulvenna, C., Awokoya, O., Gurowich, L., Dhera, K., Hayat, S., Tincknell, L., Spazzapan, M., Teeling, F., Sysum, K., Latter, J., Latter, M., Khan, S., Guruswamy, M., Beedham, W., Brazier, E., Elghobashy, M., Bajaj, M., Mann, H., Etel, E., Woodmass, M., Hayden, H., Ali, Y., Husain, S., Arnold, A., Pedersen, A. C., Cunha, P., Ahmed, M., Al Zawawi, S., Kudva, V., Theodoropoulou, K., Miscampbell, M., Robinson, A. V., Johnston, J., Dharni, A., Lamb, S., Westerman, T., Evans, E., Campbell, L., Gillespie, M., Cheong, C. M., Kulathevanayagam, K., Varghese, A., Ike, S. I., Chu, T. S. M., Baljer, B., Mogg, J. A. W., Rai, P., Claireaux, H. A., Williams, M., Smillie, R., Goetz, J., Appleby, E., Fadipe, T., Vaughan-Burleigh, S., Puri, G., Hussain, P., Flather, R., Cutler, A., Pathak, S., Sheldon, J., Collicott, T., al-Ausi, M., Jovaisaite, A., Shah, S. M., Khalid, N., Gutmann, D., Davison, S., Alame, Y. 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H., Gardner, S., Lim, J., Maden, C., Illahi, M., Xuan Tan, Z., Stahl, R., Stahl, J., Hickman, A., Collett, D., Goolam-Mahomed, Z., Allen, B., Atiyah, A., Ahmad, H., Jones, J., Mcgregor, O., Ogundiya, E., Boulbadaoui, A., Kirnon-Jackman, O., Lim, Q. X., Peckham, H., Yeoh, T., Yong, S. Q., Chen, J. Y., Siva, S., Sam, Z. H., Gilani, M., Goh, Y. N., Muthukumar, M. G., Phillips, S., Tjoakarfa, J., Giri, A., Suresan, S., Thomas, P., Johnson, T. A., Williams, R. I., Rashid, A., Kushairi, A., Rais, A., James, A., Bugelli, M., Chechelnitskaya, Y., Sandhu, N., Tandon, R., Gray, M., Kumar, A., Ciurleo, C., Nyamali, I., Hiremath, S., Sinha, S., Chowdhary, M., Bradley, E., Mctiernan, M., Macdonald, S., Sharkey, S., Mclaughlin, N., Amey, C., Kraria, L., Skan, O., Kind, C., Tupper, P., Van Rhee, C., Honeyman, S. I., Menon, G., Jegatheeswaran, L., Madhavan, A., Warne, M., Malcolm, F. L., Lessware, T., Wilkerson, H. T., Chatterjee-Woolman, S., Yoong, A., Ahmed, W. U. 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L., Trotter, J., Zaidi, A., Thakrar, V., Pulickal, P., Ahmed, H., Parnell, J., Lennock, S., Ford, V., Brignall, R., O'Neill, D., Hanna, R., Kane, R., Nicola, M., Rajput, K., Xiao, Y., Michael, S., Wright, E., Juniper, S., Thompson, E., Hoskyns, L., Kanitkar, A., Ross, C., Unsworth, A., Rshaidat, H., Demarre, K., Chiang, A., Bareh, A., van Dellen, J., Faqihinejad, C., Gadhvi, A., Grant, R., Lewsey, J., Morris, A., Martin, H., Mcclarty, C., Sanyal, S., Alsaif, A., Palkhi, A., Bhopal, S., Vishnu K, S., Papanikolaou, A., Mitra, A., Nur, A., Ali, F., Burford, C., Huq, T., Irwin, E., Matthews, L., Ngu, W. S., Hosfield, T., Muneeb, F., Page, O., Zeb, E., Al-Azzawi, A., Mcintosh, J., Vucicevic, A., Hughes, M., Brooks, L., Fanibi, B., Dixon, M., Njoku, P., Morris, D., Jobson, J., Chowdhury, H., Alawode, D. O. T., Wynell-Mayow, W., Udayachandran, V., Alsoof, D., Ekert, J., Joseph, N., Zulkefley, N., Hunt, G., Wright, O., Soman, S., Jamal, M., Beqiri, S., Borgas, P., Christie, S., Pereira, F., Browne, S., Yiu, J., Dworkin, A., Brayley, J., Palmer, A., Charalambos, M., Jones, C. J., Toner, S., Cowden, R., Lee, L., Nicol, P., Holman, O., Imtiaz, M., Albert, V., Leung, S. P., Erotocritou, M., Stroud, R., Wilkin, R., Thomson, W., Mackee, L., G, N., Bei, Y., Mckenna Favier, S., Ibrahim, A., Kler, A., Reynolds, L., Mohamed, S. H., Majeed, Y., Fakim, B., Jones, A., Liversedge, G., Carrington, Z., Windebank, J., Izzarina, A., Akbani, U., Craven, J., Aldarragi, A., Harding, S., Millward, A., Bedford, M., Gopalan, V., Midgen, A., Khadka, P., Cheng, O., Taneja, S., Manobharath, N., Kok, J. Y., Lim, D. W. E., Buick, T., Boland, M., Piya, S., Devlin, R., Fairfield, C. J., George, R. J., Rahi, M., Zaman, S., Hajiev, S., Ross, T., Crisp, E., Thompson, C., Charalambous, A., Hollywood, J. L., Hammond, R. F. L., Matthews, J., Mendonca, V., Spinty, J., Khan, K., Cheng, J., Glynn, N., Muhammad, U., Khan, M., Anderson, L., Mccormack, K., Mak, J., Patrawala, S., Milinkovic, N., Schofield, R., Chauhan, M., Hartley, L., Hind, J., Nelson, L., Ratnasingham, D., Whitehead, T., Dimitriadis, S., Marshall, K., Flint, E. J., Horner, C., Heybourne, A., Morgan, H., Wickstone, C., Panagiotou, D., O'Connell, E., Dean, K., Iqbal, R., Walsh, L., Yu, N., Rana, N., Massie, E., Ng, J., Jung, M., Lee, Y. D., Harris, M., White, S., Boev, B., Tonchev, P., Prochazka, V., Skalicky, A., Ravn, S., Ojakaar, A., Dorr-Harim, C., Koutserimpas, C., Giraudo, G., Armellini, A., Ruzzenente, A., Mazzeo, C., De Padua, C., Realis Luc, A., Maroli, A., Giani, I., Cufari, M. E., Vitali, M., Gusai, G. P., Quattromani, R., Virgilio, E., Berti, S., Di Mola, F. F., Papagni, V., Tuminello, F., Vittori, L., Longheu, A., Loche, G. A., Braccio, B., De Luca, E., Resta, G., Ancans, G., Tamosiunas, A., Petrulionis, M., Andrejevic, P., Stellingwerf, M. E., Abdulrahman, N., van de Pas, K. G. H., Thomas, G., Brandsma, A. M., Davids, J., Rottier, S. J., de Roy van Zuidewijn, D., Hawkins, R., Ong, H. I., Li, Y., Desmond, B., Winstanley, J., Martins, M., Americano, M., Frade, S., Senhorinho, R., Peixoto, R., Alves-Vale, C., Lamas, M., O'Connor, D. B., Hoo, M., Gopaul, A., Scanlon, K., O'Dwyer, N., Jovanovic, M., Panyko, A., Van Vuuren, S., Curchod, P., Gaspar, S., Imadalou, L., Mutlu, D., Akyol, C., Uygur, F. A., Eray, I. C., Biyiklioglu, O., Cetin, M. F., Isik, A. E., Karip, B., Dogan, H., Sarigul, L., Tunc, E., Aydin, T., Bodur, S., Karabulut, K., Al-hadithi, A., To, N., Lau, I. S. F., Smith, E., Mahapatra, S., Mcauliffe, O., Imam, L., Akram, B., Hossaini, S., Davies, R., Ko, M., Collins, J., Pandya, A., Reilly, S., Archer, J., Auty, C., Roche, C. D., Livie, J., Chaudhry, F. A., Ntakomyti, E., Diallo, R., Bylinski, T., Wright, J., Masiha, E., Tung, J., Shirazi, B., Neilson, A., Epton, S., Patel, N., Trussell, S., Couldrey, A., Donnelly, C., Eftychiou, S., Surgery, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, Graduate School, APH - Methodology, ACS - Heart failure & arrhythmias, Eurosurg, Collaborative, Ajmera A., Chapman, Sj, Blanco‐colino, R, Žebrák, R, Glasbey, Jc, Sgrò, A, Elst, T, Knowles, Ch, Bath, Mf, Yasin, Ih, Larsen, Hm, Rädeker, L, Frey, Pe, Elst, Tr, Fagan, Pvb, Wells, Ci, Alagoa João, A, Ozkan, Bb, Yagız Sen, A, Aktas, Mk, Baki, Be, Yüksek, B, Khaw, Ra, Ablett, Ad, Khan, Sm, Manley, Lr, Tan, Hl, Norman, Jg, Baker, Dm, Brandao, Bd, Onafowokan, Oo, Carlton‐carew, S, Shortland, Tc, Brumfitt, Cd, Luong, Jk, Kunčarová, K, Kološová, B, Farkašová, M, Harbjerg, Jl, Kjaer, Md, Mark‐christensen, A, Unbehaun, Kp, Lycke, Kd, Pohl, Lj, Christodoulou, Im, Manatakis, Dk, Aguilera, Ml, Manzoni Garberini, A, Tilocca, Pl, Piozzi, Gn, Wijnbergen, Jwm, Dinger, Tl, Doesschate, Sfh, Dalen, Ashm, Bos, Dd, Kuiper, Sz, Pruijssers, Sr, Elliott, Bm, Geneta, Vp, Peng, Sl, Lim, Yk, Neves‐marques, C, Correia, Jg, Vieira, Bn, Quintela, Ac, Serra, Ml, Aparício, Dj, Eiró, F, Almeida, Mr, Machado, Nd, Ćuk, Vv, Mészárosová, K, Ozmen, Bb, Kocer, Md, Cinar, En, Uslu, Ö, Farhan‐alanie, Mmh, Finch, Bj, Suchett‐kay, I, Liu, Fy, Nadama, Hh, Al‐saraff, Z, Tam, Jph, Powell‐chandler, A, Gorgievska, Rebecca, Gan, Fw, Makin‐taylor, R, Hey, Cy, Findlay, Jm, Örhalmi, J, Skalický, P, Skalický, T, Worsøe, J, Emmertsen, Kj, Mihaljevic, Al, Konstantinidis, Km, Bisagni, Pag, Altomare, Df, Sivinš, A, Bemelman, Wa, Graat, Lj, Wijnhoven, Bpl, Ven, Ahw, Stassen, Lp, Acherman, Yiz, Gerhards, Mf, Stommel, Mwj, Hazebroek, Ej, Geloven, Aaw, Schasfoort, Ra, Leeuwen, Bl, Tuynman, Jb, Tilburg, Mwa, Boerma, Eg, Bissett, Ip, Francisco, V, Ourô, S, Caratão, M, Silva‐vaz, P, Ridgway, Pf, Mcnamara, Da, O'Connell, Pr, Ćuk, Vm, Hübner, M, Sauvain, Mo, Geçim, Ie, Disçi, E, Haksal, Mc, Agarwal, T, Maxwell‐armstrong, C, Moug, Sj, Lund, Jn, Smart, Nj, Smith, Fm, Lee, Yj, Lai, Lt, Jun, Hj, Mendis, Dm, Robb, Pm, Lee, Hj, Wyche, Aab, Davis, Lt, Jayalath, Jmsn, Blefari, Nda, Goh, Yk, Beh, Yz, Dudi‐venkata, Nn, Borrow, Jl, Chua, Th, Tan, Rr, Ng, Sy, Britten‐jones, P, Pham, Hdv, Coulter‐nile, Smcj, Gosselink, Mp, Wang, Yl, Pös, M, Bartoš, M, Malý, O, Hanušová, M, Hurný, M, Riško, J, Treskoň, R, Pospíšil, M, Hlaváčová, L, Tomanová, D, Novický, R, Sobotková, K, šuta Kimle, K, Paclík, A, Jürgens‐lahnstein, J, Kristensen, Fp, Bønnerup, K, Højgaard Pedersen, J, Jepsen, Bn, Hillgaard, Tk, Erichsen, Sb, Nielsen, Cv, Madsen, Cp, Skejø, Cd, Aabling, Rr, Sørensen, J, Schöning, L, Simon, S CS, Thäwel, T, Seckler, Am, Athanasopoulos, Pg, Giuffrida, Mc, Billo, Me, Marrosu, Ag, Ruggiu, Mw, Antona, Ad, Bitonti, Mf, Romano, Fm, Pellicanò, Ga, Murru, Ml, Angelucci, Gp, Tenconi, Sm, Mura, Fa, Ruggiu, Gv, Mura, Ga, Perrone, Ba, Esposito, Lm, Marcianò, M, Aru, Ac, Figà, F, Truškovs, A, Machatschek, Mj, Wiemann, Am, Müller, Nl, Samalavicius, Ne, Poškus, E, Kryžauskas, M, Poškus, T, Looyen, R, Becker, Maj, Molder, L, Tissen, Ym, Vries, H, Smaalen, Tc, Veen, Oc, Dingemans, Sa, Brink, Lc, Vijgen, Ghej, Voort, Emf, Pool, A, Rest, Klc, Sluijpers, Nrf, Molenaar, Cjl, Gordinou de Gouberville, Mc, Mens, Ma, Hoeks, Em, Praag, Em, Smit, Mpcm, Lely, Sj, Stijns, Rch, Leow, Ty, Ruiter, A, Aarts, Cam, Jonge, J, Alqethami, Hj, Elst, Pc, Tissink, Mw, Grüter, A, Voeten, Dm, Boon, Cl, Franssen, Rjm, Jense, Mtf, Lau, Wk, Adams, Sib, Chen, Sy, Kim, Dh, Mclaughlin, Sjp, Chapman, Da, Mcintosh, Nd, Tewhaiti‐smith, J, Yam, St, Tomé, M, Santos, Tc, Lages, Rr, Sá, Tc, Bernardes, Fm, Cunha, Mf, Veiga, Dn, Loureiro, Ar, Torre, Ap, Paixão, I, Rocha, Af, Jervis, Mj, Paixão, V, Silva, Ag, Galvão, D, Mónica, I, Guimarães, N, Martins, Sf, Rocha‐melo, M, Patrício, J, Cinza, Am, Simões, J, Gonçalves, Jp, Guimarães, J, Martins, Ar, Lérias, R, Bártolo, J, Correia, Am, Martins, Pc, Jardim, Jam, Domingos, Sp, Baião, Jm, Lopes, Nmro, Jordão, Dm, Ângelo, Md, Caroço, T, Gomes, Jr, Monteiro, Rg, Colon, Lf, Dockry, É, Aly, Ak, Kang, Sj, Pentony, Ar, Piong, Cl, Eow, Sy, Kamath, Pj, Soh, Tbw, Dyer, Ah, Chee, Sy, Tan, Ixh, Jones, Mr, Al‐salihi, A, Ciubotaru, Ci, Radulović, R, Miloševic, K, Bojičić, J, Genčić, M, Janković, U, Sucháň, Pk, Dubovský, M, Sautter, Sc, Mcduling, Cr, Haller, Ml, Piotet, Lm, Kurtoglu, Gk, Sel, Ek, Isler, Vc, Demirkaya, Hc, Korkmaz, Hk, Pektas, Am, Güner, B, İşlek, Ec, Tombul, Hb, Boztuğ, Cy, Tınaz, A, Yılmaz, M, Akın, Fa, Başçavuş, M, Seker, Mc, Koçak, Zb, Karapinar, Ye, Köseoglu, E, Agca, Mh, Alim, Ye, Kürklü, Ö, Çalar, Sn, Kavar, Rc, Cevlik, Ad, Turk, Eg, Erdönmez, H, Gürsoy, F, Önsal, U, Özbek, M, Kasar, Pa, Özen, D, Ölmez, M, Sariçiçek, T, Tipi, Ou, Benli, Ge, Bilgili, Ac, Kiraz, In, Aksoy, Ab, Karagöz, E, Tümer, S, Abdulrahman, Smf, Kuyumcu, Of, Afsar, Hb, Guler, Se, Gul, Eb, Dossa, Saa, Mizan, Sr, Sahin, Az, Kilinç, A, Yumurtaci, Ö, Girit, Çagri, Yildirak, Mk, Güldag, A, Söyleyici, B, Aytin, Ye, Akay, Fe, Iskan, Ng, Sunay, Ao, Tie‐gill, T, Delaugere, Lp, Yeo, Yq, Aly, Mh, Dwyer‐hemmings, L, Bin Amran, Am, Kyaw, Ha, Clements, Jm, Wong, Hl, Armitage, Mn, Hassan Serry, My, Tam, Lyc, Sookramanien, Sr, Ward, Kl, Pherwani, Sa, Drury, Dj, James, Sj, Teasdale, Ab, Richardson, Etj, Thomas, Da, Williams, Rl, Najabat‐lattif, Hf, Zhu, Ly, Suchett‐kaye, I, Mihailidis, Th, Pedersen, Ac, Robinson, Av, Cheong, Cm, Ike, Si, Chu, Tsm, Mogg, Jaw, Claireaux, Ha, Vaughan‐burleigh, S, Al‐ausi, M, Shah, Sm, Alame, Yj, Owen, Wj, Ahsan, Sd, Anthony‐uzoeto, U, Adam, Ah, Parekh, Jn, Ul‐hasan, S, Martin‐hernandez, Mp, Soh, Yj, Al‐sarraf, Z, Rassool, Sb, Mcmillan, Mja, Ling, Jj, Howard, Eo, Wadsworth, Oj, Meney, Lc, Kang, Ck, Chiu, Jzj, Tan, Qj, Cross, Gwv, Shah, Dr, Ng, Mpe, Wong, Rtw, Rojoa, Dm, Ruddy, Cm, Hall, Jd, Hassane, Asi, Azhar, Aw, Tan, Tk, Kwak, Sy, Ong, Eh, Goolam‐mahomed, Z, Kirnon‐jackman, O, Lim, Qx, Yong, Sq, Chen, Jy, Sam, Zh, Goh, Yn, Muthukumar, Mg, Johnson, Ta, Williams, Ri, Honeyman, Si, Malcolm, Fl, Wilkerson, Ht, Chatterjee‐woolman, S, Ahmed, Wur, Kwan, Kwl, Sanders‐crook, L, Boh, Zy, English, Wj, Novotny, Sa, Chong, Jt, Lee, De, Embury‐young, Y, Clavé Llavall, A, Pang, Yl, Dellen, J, Al‐azzawi, A, Alawode, Dot, Wynell‐mayow, W, Christodoulou, T, Jones, Cj, Leung, Sp, Mohamed, Sh, Kok, Jy, Lim, Dwe, Fairfield, Cj, George, Rj, Hollywood, Jl, Hammond, Rfl, Flint, Ej, Lee, Yd, Skalický, A, Ojakäär, A, Dörr‐harim, C, Cufari, Me, Gusai, Gp, Di Mola, Ff, Loche, Ga, Stellingwerf, Me, Pas, Kgh, Brandsma, Am, Rottier, Sj, Roy van Zuidewijn, D, Ong, Hi, Alves‐vale, C, O'Connor, Db, Jovanović, M, Uygur, Fa, Eray, Ic, Çetin, Mf, Isik, Ae, Sarıgül, L, Francis, Aa, Al‐hadithi, A, Lau, Isf, Roche, Cd, and Chaudhry, Fa

Subjects
Male, renal failure, Time Factors, medicine.medical_treatment, Adult, Aged, Anti-Inflammatory Agents, Non-Steroidal, Elective Surgical Procedures, Female, Humans, Ileus, Kaplan-Meier Estimate, Middle Aged, Patient Safety, Postoperative Care, Postoperative Complications, Proportional Hazards Models, Prospective Studies, Recovery of Function, Treatment Outcome, Colectomy, Proctectomy, Anti-Inflammatory Agents, colorectal surgery, ileus, non-steroidal anti-inflammatory drugs, NSAIDS, 030230 surgery, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Prospective cohort study, Colorectal, RISK, Hazard ratio, Acute kidney injury, Colorectal surgery, NSAID, 030220 oncology & carcinogenesis, Non-Steroidal, Cohort study, colorectal Surgery, ileus, non-steroidal anti-inflammatory drugs, medicine.medical_specialty, Non‐steroidal anti‐inflammatory drugs. NSAIDs. Postoperative ileus. Colorectal surgery, ACUTE KIDNEY INJURY, anti-inflammatory agents, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, non-steroidal anti-inflammatory drugs - ileus - colorectal surgery, business.industry, medicine.disease, Settore MED/18 - Chirurgia Generale, colorectal cancer, Surgery, business
Abstract

Ileus is common after elective colorectal surgery, and is associated with increased adverse events and prolonged hospital stay. The aim was to assess the role of non-steroidal anti-inflammatory drugs (NSAIDs) for reducing ileus after surgery.A prospective multicentre cohort study was delivered by an international, student- and trainee-led collaborative group. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The primary outcome was time to gastrointestinal recovery, measured using a composite measure of bowel function and tolerance to oral intake. The impact of NSAIDs was explored using Cox regression analyses, including the results of a centre-specific survey of compliance to enhanced recovery principles. Secondary safety outcomes included anastomotic leak rate and acute kidney injury.A total of 4164 patients were included, with a median age of 68 (i.q.r. 57-75) years (54·9 per cent men). Some 1153 (27·7 per cent) received NSAIDs on postoperative days 1-3, of whom 1061 (92·0 per cent) received non-selective cyclo-oxygenase inhibitors. After adjustment for baseline differences, the mean time to gastrointestinal recovery did not differ significantly between patients who received NSAIDs and those who did not (4·6 versus 4·8 days; hazard ratio 1·04, 95 per cent c.i. 0·96 to 1·12; P = 0·360). There were no significant differences in anastomotic leak rate (5·4 versus 4·6 per cent; P = 0·349) or acute kidney injury (14·3 versus 13·8 per cent; P = 0·666) between the groups. Significantly fewer patients receiving NSAIDs required strong opioid analgesia (35·3 versus 56·7 per cent; P 0·001).NSAIDs did not reduce the time for gastrointestinal recovery after colorectal surgery, but they were safe and associated with reduced postoperative opioid requirement.El ileo es frecuente tras cirugía colorrectal electiva y se asocia con un incremento de los eventos adversos y de la duración de la estancia hospitalaria. El objetivo fue evaluar el papel de los fármacos antiinflamatorios no esteroideos (non-steroidal anti-inflammatory drugs, NSAIDs) para reducir el ileo tras la cirugía. MÉTODOS: Estudio de cohortes prospectivo y multicéntrico efecuado por un grupo colaborativo dirigido por estudiantes y cirujanos en formación. Se incluyeron pacientes adultos sometidos a cirugía colorectal electiva entre enero y abril 2018. El resultado primario fue el tiempo hasta la recuperaciòn gastrointestinal, medido por una variable compuesta de función intestinal y tolerancia a la alimentación oral. El impacto de los NSAIDs se exploró utilizando un análisis de regresión de Cox, que incluía los resultados de una encuesta específica dirigida a los centros sobre la adherencia a los principios de la recuperación intensificada. Los resultados secundarios de seguridad incluyeron la dehiscencia anastomótica y la insuficiencia renal aguda.Se incluyeron 4.164 pacientes con una mediana de edad de 68 años (rango intercuartílico: 57-75; 54,9% varones). Un total de 1.153 (27,7%) pacientes fueron tratados con NSAIDs en los días postoperarorios 1-3, de los cuales 1.061 (92,0%) recibieron inhibidores no selectivos de la ciclooxigenasa. Tras los ajustes por las diferencias basales, el tiempo medio hasta la recuperación gastrointestinal no difería significativamente entre pacientes que recibieron o no recibieron NSAIDs (4,6 versus 4,8 días; cociente de riesgos instantáneos, hazard ratio, HR 1,04, i.c. del 95%: 0,96-1,12, P = 0,360). No hubo diferencias significativas en la tasa de dehiscencias anastomóticas (5,4% versus 4,6%; P = 0,349) o insuficiencia renal aguda (14,3% versus 13,8%; P = 0,666) entre los grupos. Sin embargo, significativamente menos pacientes de los que recibieron NSAIDs precisaron una analgesia intensa con opioides (35,3% versus 56,7%; P 0,001). CONCLUSIÓN: La administración de NSAIDs no redujo el tiempo hasta la recuperación gastrointestinal tras cirugía colorrectal, pero fueron seguros y se asociaron con una reducción en la necesidad de opioides postoperarorios.

Published
2019

38. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis

Author

Massimo Cristofanilli, Manuela Milani, Lucia Del Mastro, Grazia Arpino, Antonio Giordano, Aleix Prat, Mario Giuliano, Michelino De Laurentiis, Barbara Pistilli, Thomas Bachelot, Guglielmo Thomas, Sabino De Placido, Carla Rognoni, Pietro De Placido, Daniele Generali, Sergio Venturini, Fabio Puglisi, Guy Jerusalem, Francesco Schettini, Giuliano, M., Schettini, F., Rognoni, C., Milani, M., Jerusalem, G., Bachelot, T., De Laurentiis, M., Thomas, G., De Placido, P., Arpino, G., De Placido, S., Cristofanilli, M., Giordano, A., Puglisi, F., Pistilli, B., Prat, A., Del Mastro, L., Venturini, S., Generali, D., Giuliano, Mario, Schettini, Francesco, Rognoni, Carla, Milani, Manuela, Jerusalem, Guy, Bachelot, Thoma, De Laurentiis, Michelino, Thomas, Guglielmo, De Placido, Pietro, Arpino, Grazia, De Placido, Sabino, Cristofanilli, Massimo, Giordano, Antonio, Puglisi, Fabio, Pistilli, Barbara, Prat, Aleix, Del Mastro, Lucia, Venturini, Sergio, Generali, Daniele, Bachelot, LUC HENRI JEAN MARIE, DE PLACIDO, Pietro, and Generali, Ada

Subjects
0301 basic medicine, Oncology, Pyridines, Receptor, ErbB-2, medicine.medical_treatment, Network Meta-Analysis, Aminopyridines, postmenopausal women, chemotherapy, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Exemestane, endocrine treatment, metastatic breast cancer, HER2-negative, Antineoplastic Combined Chemotherapy Protocols, Fulvestrant, Randomized Controlled Trials as Topic, Letrozole, Chemotherapy regimen, Progression-Free Survival, Bevacizumab, Postmenopause, Receptors, Estrogen, Settore SECS-S/01 - STATISTICA, 030220 oncology & carcinogenesis, Female, Receptors, Progesterone, medicine.drug, medicine.medical_specialty, Antineoplastic Agents, Hormonal, Paclitaxel, Anastrozole, Breast Neoplasms, Palbociclib, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Internal medicine, medicine, Humans, Everolimus, business.industry, Androstadienes, Regimen, 030104 developmental biology, Clinical Trials, Phase III as Topic, chemistry, Purines, Benzimidazoles, Hormone therapy, business
Abstract

Summary Background Although international guidelines support the administration of hormone therapies with or without targeted therapies in postmenopausal women with hormone-receptor-positive, HER2-negative metastatic breast cancer, upfront use of chemotherapy remains common even in the absence of visceral crisis. Because first-line or second-line treatments, or both, based on chemotherapy and on hormone therapy have been scarcely investigated in head-to-head randomised controlled trials, we aimed to compare these two different approaches. Methods We did a systematic review and network meta-analysis with a systematic literature search on PubMed, Embase, Cochrane Central Register of Clinical Trials, Web of Science, and online archives of the most relevant international oncology conferences. We included all phase 2 and 3 randomised controlled trials investigating chemotherapy with or without targeted therapies and hormone therapies with or without targeted therapies as first-line or second-line treatments, or both, in postmenopausal women with hormone-receptor-positive, HER2-negative metastatic breast cancer, published between Jan 1, 2000, and Dec 31, 2017. Additional recently published randomised controlled trials relevant to the topic were also subsequently added. No language restrictions were adopted for our search. A Bayesian network meta-analysis was done to compare hazard ratios (HRs) for progression-free survival (the primary outcome), and to compare odds ratios (ORs) for the proportion of patients achieving an overall response (the secondary outcome). All treatments were compared to anastrozole and to palbociclib plus letrozole. This study is registered in the Open Science Framework online public database, registration DOI 10.17605/OSF.IO/496VR. Findings We identified 2689 published results and 140 studies (comprising 50 029 patients) were included in the analysis. Palbociclib plus letrozole (HR 0·42; 95% credible interval [CrI] 0·25–0·70), ribociclib plus letrozole (0·43; 0·24–0·77), abemaciclib plus anastrozole or letrozole (0·42; 0·23–0·76), palbociclib plus fulvestrant (0·37; 0·23–0·59), ribociclib plus fulvestrant (0·48; 0·31–0·74), abemaciclib plus fulvestrant (0·44; 0·28–0·70), everolimus plus exemestane (0·42; 0·28–0·67), and, in patients with a PIK3CA mutation, alpelisib plus fulvestrant (0·39; 0·22–0·66), and several chemotherapy-based regimens, including anthracycline and taxane-containing regimens, were associated with better progression-free survival than was anastrozole alone. No chemotherapy or hormone therapy regimen was significantly better than palbociclib plus letrozole for progression-free survival. Paclitaxel plus bevacizumab was the only clinically relevant regimen that was significantly better than palbociclib plus letrozole in terms of the proportion of patients achieving an overall response (OR 8·95; 95% CrI 1·03–76·92). Interpretation In the first-line or second-line setting, CDK4/6 inhibitors plus hormone therapies are better than standard hormone therapies in terms of progression-free survival. Moreover, no chemotherapy regimen with or without targeted therapy is significantly better than CDK4/6 inhibitors plus hormone therapies in terms of progression-free survival. Our data support treatment guideline recommendations involving the new combinations of hormone therapies plus targeted therapies as first-line or second-line treatments, or in both settings, in women with hormone-receptor-positive, HER2-negative metastatic breast cancer. Funding None.

Published
2019

39. Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial

Author

Lucia Del Mastro, Matteo Lambertini, Michelino De Laurentiis, Teresa Gamucci, Marco Bruzzone, Piero Fregatti, Sabino De Placido, Eva Blondeaux, Loredana Miglietta, Francesco Cognetti, Claudia Bighin, Gim investigators, Francesca Poggio, E. Valle, Benedetta Conte, Francesco Boccardo, Cecilia Nisticò, Fabio Puglisi, Barbara Cardinali, Filippo Montemurro, Ornella Garrone, Marcello Ceppi, Conte, B., Bruzzone, M., Lambertini, M., Poggio, F., Bighin, C., Blondeaux, E., De Laurentiis, M., Valle, E., Cognetti, F., Nistico, C., De Placido, S., Garrone, O., Gamucci, T., Montemurro, F., Puglisi, F., Cardinali, B., Fregatti, P., Miglietta, L., Boccardo, F., Ceppi, M., and Del Mastro, L.

Subjects
0301 basic medicine, Cancer Research, Dose-dense chemotherapy, Receptor, ErbB-2, Luminal subtype, Gastroenterology, Cohort Studies, 0302 clinical medicine, Breast cancer, Antineoplastic Combined Chemotherapy Protocols, Medicine, Hormone receptor-positive, Aged, 80 and over, Hazard ratio, Middle Aged, Prognosis, Immunohistochemistry, Phenotype, Oncology, Receptors, Estrogen, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Cohort, Disease Progression, Female, Receptors, Progesterone, Breast Neoplasm, Epirubicin, medicine.drug, Human, Adult, medicine.medical_specialty, Prognosi, Breast Neoplasms, 03 medical and health sciences, Internal medicine, Adjuvant therapy, Humans, Survival analysis, Cancer staging, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocol, Dose-Response Relationship, Drug, business.industry, medicine.disease, Survival Analysis, 030104 developmental biology, Cohort Studie, business
Abstract

Background: Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes. Methods: Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 < 20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR < 20%. Results: Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4–84.5) and 70.5% (66.5–74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2–94.1) and 85.1% (81.7–87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54–0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40–0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59–1.33]; unadjusted HR for OS 0.83 [95% CI 0.45–1.54]). Conclusions: No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule.

Published
2020

40. Overall survival of CDK4/6-inhibitors-based treatments in clinically relevant subgroups of metastatic breast cancer: systematic review and meta-analysis

Author

Lucia Del Mastro, Pietro De Placido, Sergio Venturini, Fabio Puglisi, Michelino De Laurentis, Guy Jerusalem, Francesco Schettini, Pierfranco Conte, Massimo Cristofanilli, Fabiola Giudici, Grazia Arpino, Dejan Juric, Sabino De Placido, Daniele Generali, Antonio Llombart-Cussac, Mario Giuliano, Lajos Pusztai, Ida Paris, Aleix Prat, Angelo Di Leo, Schettini, F., Giudici, F., Giuliano, M., Cristofanilli, M., Arpino, G., Del Mastro, L., Puglisi, F., De Placido, S., Paris, I., De Placido, P., Venturini, S., De Laurentis, M., Conte, P., Juric, D., Llombart-Cussac, A., Pusztai, L., Prat, A., Jerusalem, G., Di Leo, A., and Generali, D.

Subjects
Oncology, Cancer Research, Pyridines, medicine.medical_treatment, metastatic breast cancer treatment, Menopausal status, endocrine sensitiveness, CDK4/6-Inhibitor, metastatic breast cancer treatments, Review, Piperazines, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, Menopausal statu, Medicine, Neoplasm Metastasis, subgroup analysis, Randomized Controlled Trials as Topic, 0303 health sciences, CDK4/6-inhibitors, Metastatic breast cancer, Chemotherapy regimen, endocrine sensitivene, Settore SECS-S/01 - STATISTICA, 030220 oncology & carcinogenesis, Meta-analysis, Letrozole, Female, metastatic breast cancer, medicine.medical_specialty, overall survival, Subgroup analysis, Breast Neoplasms, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Internal medicine, Humans, Progression-free survival, Protein Kinase Inhibitors, 030304 developmental biology, hormone therapy, business.industry, hormone receptors, Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6, medicine.disease, Clinical trial, Clinical Trials, Phase III as Topic, Hormone therapy, business
Abstract

Background Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors + endocrine therapy (ET) prolonged progression-free survival as first- or second-line therapy for hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer prognosis. Given the recent publication of overall survival (OS) data for the 3 CDK4/6-inhibitors, we performed a meta-analysis to identify a more precise and reliable benefit from such treatments in specific clinical subgroups. Methods We conducted a systematic literature search to select all available phase II or III randomized clinical trials of CDK4/6-inhibitors + ET reporting OS data in first- or second-line therapy of HR+/HER2-negative pre- or postmenopausal metastatic breast cancer. A random effect model was applied for the analyses. Heterogeneity was assessed with I2statistic. Subgroup analysis was performed to explore the effect of study-level factors. The project was registered in the Open Science Framework database (doi: 10.17605/OSF.IO/TNZQP). Results Six studies were included in our analyses (3421 patients). A clear OS benefit was observed in patients without (hazard ratio [HR] = 0.68, 95% confidence interval [CI] = 0.54 to 0.85, I2 = 0.0%) and with visceral involvement (HR = 0.76, 95% CI = 0.65 to 0.89, I2 = 0.0%), with at least 3 metastatic sites (HR = 0.75, 95% CI = 0.60 to 0.94, I2 = 11.6%), in an endocrine-resistant (HR = 0.79, 95% CI = 0.67 to 0.93, I2 = 0.0%) and sensitive subset (HR = 0.73, 95% CI = 0.61 to 0.88, I2 = 0.0%), for younger than 65 years (HR = 0.80, 95% CI = 0.67 to 0.95, I2 = 0.0%) and 65 years or older (HR = 0.71, 95% CI = 0.53 to 0.95, I2 = 44.4%), in postmenopausal (HR = 0.76, 95% CI = 0.67 to 0.86, I2 = 0.0%) and pre- or perimenopausal setting (HR = 0.76, 95% CI = 0.60 to 0.96, I2 = 0.0%) as well as in chemotherapy-naïve patients (HR = 0.72, 95% CI = 0.55 to 0.93, I2 = 0.0%). Conclusions CDK4/6-inhibitors + ET combinations compared with ET alone improve OS independent of age, menopausal status, endocrine sensitiveness, and visceral involvement and should be preferred as upfront therapy instead of endocrine monotherapy.

Published
2020

41. Overview of epstein–barr-virus-associated gastric cancer correlated with prognostic classification and development of therapeutic options

Author

Gianmaria Miolo, Valli De Re, Ombretta Repetto, Stefania Zanussi, Lara Alessandrini, Mariangela De Zorzi, Vincenzo Canzonieri, Renato Cannizzaro, Fabio Puglisi, Agostino Steffan, Claudio Belluco, Giulia Brisotto, Laura Caggiari, De Re, V., Brisotto, G., Repetto, O., De Zorzi, M., Caggiari, L., Zanussi, S., Alessandrini, L., Canzonieri, V., Miolo, G., Puglisi, F., Belluco, C., Steffan, A., and Cannizzaro, R.

Subjects
0301 basic medicine, Oncology, Herpesvirus 4, Human, medicine.medical_specialty, Carcinogenesis, Review, Disease, Epstein–Barr, medicine.disease_cause, Catalysis, Virus, lcsh:Chemistry, Inorganic Chemistry, Pathogenesis, 03 medical and health sciences, 0302 clinical medicine, Immune system, Stomach Neoplasms, Internal medicine, Genotype, medicine, Animals, Humans, Physical and Theoretical Chemistry, lcsh:QH301-705.5, Molecular Biology, Spectroscopy, Carcinogenesi, business.industry, Organic Chemistry, General Medicine, Cell Transformation, Viral, Phenotype, Epstein–Barr virus, Computer Science Applications, 030104 developmental biology, lcsh:Biology (General), lcsh:QD1-999, 030220 oncology & carcinogenesis, Host-Pathogen Interactions, Gastric cancer, Targeted drugs, business
Abstract

Gastric cancer (GC) is a deadly disease with poor prognosis that is characterized by heterogeneity. New classifications based on histologic features, genotypes, and molecular phenotypes, for example, the Cancer Genome Atlas subtypes and those by the Asian Cancer Research Group, help understand the carcinogenic differences in GC and have led to the identification of an Epstein–Barr virus (EBV)-related GC subtype (EBVaGC), providing new indications for tailored treatment and prognostic factors. This article provides a review of the features of EBVaGC and an update on the latest insights from EBV-related research with a particular focus on the strict interaction between EBV infection and the gastric tumor environment, including the host immune response. This information may help increase our knowledge of EBVaGC pathogenesis and the mechanisms that sustain the immune response of patients since this mechanism has been demonstrated to offer a survival advantage in a proportion of patients with GC.

Published
2020

42. Decreased in-hospital mortality in patients with COVID-19 pneumonia

Author

Riccardo Puglisi, Rosalba Lembo, Giovanni Landoni, Annalisa Ruggeri, Alberto Zangrillo, Fabio Ciceri, Ciceri, Fabio, Ruggeri, Annalisa, Lembo, Rosalba, Puglisi, Riccardo, Landoni, Giovanni, and Zangrillo, Alberto

Subjects
0301 basic medicine, ARDS, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, 030106 microbiology, 030231 tropical medicine, Acute respiratory distress, Microbiology, Asymptomatic, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Air Pollution, Internal medicine, medicine, Humans, In patient, Hospital Mortality, Pandemics, In hospital mortality, SARS-CoV-2, business.industry, Mortality rate, Public Health, Environmental and Occupational Health, COVID-19, General Medicine, medicine.disease, mortality, Pneumonia, Infectious Diseases, age, Parasitology, medicine.symptom, Coronavirus Infections, business
Abstract

Clinical manifestations of COVID-19 may range from asymptomatic to severe interstitial pneumonia with acute respiratory distress syndrome (ARDS) and death. COVID-19 mortality rates vary greatly [1]...

Published
2020

43. Type IV Laryngotracheoesophageal Cleft Associated with Type III Esophageal Atresia in 1p36 Deletions Containing the RERE Gene: Is There a Causal Role for the Genetic Alteration?

Author

Maria Lapi, Maria Piccione, Federico Matina, Martina Busè, Giovanni Battista Mura, Gloria Pelizzo, Valeria Calcaterra, Giuseppe Re, Aurora Puglisi, Pelizzo, Gloria, Puglisi, Aurora, Lapi, Maria, Piccione, Maria, Matina, Federico, Busè, Martina, Mura, Giovanni Battista, and Calcaterra, Valeria

Subjects
0301 basic medicine, medicine.medical_specialty, Type IV Laryngotracheoesophageal Cleft, Type III Esophageal Atresia, 1p36 Deletions, RERE Gene, medicine.medical_treatment, Anastomosis, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Thoracotomy, Esophagus, 030223 otorhinolaryngology, Epigenomics, business.industry, lcsh:RJ1-570, lcsh:Pediatrics, General Medicine, medicine.disease, Phenotype, 030104 developmental biology, medicine.anatomical_structure, Atresia, Failure to thrive, medicine.symptom, business, Haploinsufficiency
Abstract

The causes of embryological developmental anomalies leading to laryngotracheoesophageal clefts (LTECs) are not known, but are proposed to be multifactorial, including genetic and environmental factors. Haploinsufficiency of the RERE gene might contribute to different phenotypes seen in individuals with 1p36 deletions. We describe a neonate of an obese mother, diagnosed with type IV LTEC and type III esophageal atresia (EA), in which a 1p36 deletion including the RERE gene was detected. On the second day of life, a right thoracotomy and extrapleural esophagus atresia repair were attempted. One week later, a right cervical approach was performed to separate the cervical esophagus from the trachea. Three months later, a thoracic termino-terminal anastomosis of the esophagus was performed. An anterior fundoplication was required at 8 months of age due to severe gastroesophageal reflux and failure to thrive. A causal role of 1p36 deletions including the RERE gene in the malformation is proposed. Moreover, additional parental factors must be considered. Future studies are mandatory to elucidate genomic and epigenomic susceptibility factors that underlie these congenital malformations. A multiteam approach is a crucial factor in the successful management of affected patients.

Published
2018

44. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial

Author

I. Migliaccio, Antonio Bernardo, Chiara Biagioni, Giuseppe Curigliano, Carmen Criscitiello, Marc Buyse, Carlo Tondini, Giovanni Sanna, Luca Boni, Saverio Cinieri, Emanuela Risi, Fabio Puglisi, Marta Pestrin, Erica Moretti, K. D’Hollander, Amelia McCartney, Laura Biganzoli, Alessandro Marco Minisini, Luca Malorni, Angelo Martignetti, Grazia Arpino, A. Di Leo, Malorni, L, Curigliano, G, Minisini, A M, Cinieri, S, Tondini, C A, D'Hollander, K, Arpino, G, Bernardo, A, Martignetti, A, Criscitiello, C, Puglisi, F, Pestrin, M, Sanna, G, Moretti, E, Risi, E, Biagioni, C, Mccartney, A, Boni, L, Buyse, M, Migliaccio, I, Biganzoli, L, and Di Leo, A

Subjects
Adult, 0301 basic medicine, Oncology, medicine.medical_specialty, Combination therapy, Pyridines, Receptor, ErbB-2, Breast Neoplasms, Palbociclib, Piperazines, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Progression-free survival, Aged, Aged, 80 and over, business.industry, Estrogen Antagonists, Cancer, Original Articles, Hematology, Middle Aged, medicine.disease, Survival Analysis, Metastatic breast cancer, Progression-Free Survival, Clinical trial, 030104 developmental biology, Receptors, Estrogen, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Disease Progression, Female, business
Abstract

Background The activity of palbociclib as a single agent in advanced breast cancer has not been extensively studied, with the only available clinical data limited to heavily pretreated patients. Preclinical data suggests palbociclib may partially reverse endocrine resistance, though this hypothesis has not been evaluated in previous clinical studies. This phase II, open-label, multicenter study examined the activity of palbociclib monotherapy, as well as palbociclib given in combination with the same endocrine therapy (ET) that was received prior to disease progression, in postmenopausal women with moderately pretreated, estrogen receptor-positive, HER2 negative advanced breast cancer. Patients and methods Eligible women with advanced disease which had progressed on one or two prior ETs were randomized 1 : 1 to receive either palbociclib alone, or palbociclib in combination with the ET as previously received. Primary end point was clinical benefit rate (CBR); secondary end points included progression-free survival (PFS). Results Between October 2012 and July 2016, a total of 115 patients were randomized. The CBR was 54% [95% confidence interval (CI): 41.5–63.7] for combination therapy, and 60% (95% CI: 47.8–72.9) for monotherapy. Median PFS was 10.8 months (95% CI: 5.6–12.7) for combination therapy, and 6.5 months (95% CI: 5.4–8.5) for monotherapy [hazard ratio (HR) 0.69; 95% CI: 0.4–1.1, exploratory P-value = 0.12]. Exploratory analyses revealed the PFS advantage for combination therapy was seen in the subgroup of patients who received prior ET for >6 months (HR 0.53; 95% CI: 0.3–0.9, exploratory P-value = 0.02), but not in those who received prior ET for ≤6 months. Conclusion Palbociclib has clinical activity as a single agent in women with moderately pretreated, oestrogen receptor-positive, HER2-negative advanced breast cancer. Palbociclib may have potential to reverse endocrine resistance in patients with a history of previous durable response to ET. Clinical trial information NCT02549430

Published
2018

45. Human epidermal growth factor receptor 2 dual blockade with trastuzumab and pertuzumab in real life: Italian clinical practice versus the CLEOPATRA trial results

Author

Michelino De Laurentiis, Dario Bruzzese, Roberta Caputo, Ferdinando Riccardi, Andrea Michelotti, Mariavittoria Locci, Vito Lorusso, Fabio Puglisi, Marta Bonotto, Claudia von Arx, Mariangela Ciccarese, Francesco Schettini, Domenico Bilancia, Sabino De Placido, Grazia Arpino, Daniela Cianniello, Alessandra Fabi, Giuseppe Buono, Bianca Maria Veneziani, Mario Giuliano, De Placido, Sabino, Giuliano, Mario, Schettini, Francesco, VON ARX, Claudia, Buono, Giuseppe, Riccardi, Ferdinando, Cianniello, Daniela, Caputo, Roberta, Puglisi, Fabio, Bonotto, Marta, Fabi, Alessandra, Bilancia, Domenico, Ciccarese, Mariangela, Lorusso, Vito, Michelotti, Andrea, Bruzzese, Dario, Veneziani, Bianca Maria, Locci, Mariavittoria, De Laurentiis, Michelino, and Arpino, Grazia

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, Docetaxel, Clinical practice, law.invention, Breast cancer, 0302 clinical medicine, Randomized controlled trial, Trastuzumab, law, Observational study, Antineoplastic Combined Chemotherapy Protocols, Medicine, skin and connective tissue diseases, Randomized Controlled Trials as Topic, Aged, 80 and over, education.field_of_study, General Medicine, Middle Aged, HER2, Paclitaxel, Pertuzumab, Real life, Surgery, Metastatic breast cancer, Treatment Outcome, Italy, 030220 oncology & carcinogenesis, Female, Taxoids, medicine.drug, Adult, Bridged-Ring Compounds, medicine.medical_specialty, Population, Breast Neoplasms, Antibodies, Monoclonal, Humanized, Disease-Free Survival, Young Adult, 03 medical and health sciences, Internal medicine, Humans, education, Aged, Retrospective Studies, Taxane, business.industry, Retrospective cohort study, medicine.disease, 030104 developmental biology, business
Abstract

Objectives Given their inclusion and exclusion criteria, randomized clinical trials (RCT) might not include a population that truly mirrors real life (RL). This raises concerns about the applicability of RCT results in clinical practice. We evaluated the efficacy of anti-HER2 treatment with pertuzumab combined with trastuzumab and a taxane as first-line treatment for HER2-positive metastatic breast cancer in a RL setting, and compared the safety results obtained in our population versus the experimental cohort of the CLEOPATRA RCT, which led to the approval of this therapy. Materials and methods Patients treated with trastuzumab, pertuzumab and a taxane were enrolled in this retrospective study. We compared the tumor features and the patients' characteristics of the RL cohort to those of the CLEOPATRA cohort. We also compared the median progression-free survival (PFS) in the RL population versus specific patients' subgroups. Results RL patients were more frequently HR-positive, less likely to have visceral metastases (P

Published
2018

46. Sarcina Ventriculi infection: a rare but fearsome event. A Systematic Review of the Literature

Author

Giacomo Taddei, Massimo Chiarugi, Enrico Cicuttin, A Puglisi, Clara Ugolini, Iosè Di Stefano, Silvia Strambi, Dario Tartaglia, Camilla Cremonini, Alessio Mazzoni, Fulvio Basolo, and Federico Coccolini

Subjects
Microbiology (medical), medicine.medical_specialty, Sarcina, Perforation (oil well), MEDLINE, Stomach Diseases, Infectious and parasitic diseases, RC109-216, Urine, Internal medicine, Biopsy, medicine, Humans, Sarcina ventriculi, Literature Review, Clostridium, Gastrointestinal tract, medicine.diagnostic_test, biology, business.industry, General Medicine, Middle Aged, biology.organism_classification, Anti-Bacterial Agents, Infectious Diseases, Gastritis, Sarcina Ventriculi, Female, medicine.symptom, business
Abstract

Objectives This study is aimed to report a case of SV-related gastritis and the results of a systematic review of SV infections in the literature. Methods Following a case presentation, we systematically searched different databases (MEDLINE, PubMed, Scopus, Web of Science, EMBASE) for the items “sarcina,” “ventriculi,” “clostridium” with AND/OR. Results A total of 55 articles reporting 65 cases of Sarcina Ventriculi were found. Thus, 66 patients, including our case, were reviewed. Median age was 51 years (IQR: 0-87 years). Females accounted for 51% of cases. 68% of patients had one or more comorbidities. SV was isolated in the gastrointestinal tract (88%), respiratory (5%), urine (4%), and bloodstream (3%) systems. Upper endoscopy was performed in 52 patients (79%). Biopsies were obtained in all 52 cases, and resulted normal in 23%. Surgery was warranted in 15 patients (23%), and specific antimicrobial therapy was delivered in 34 (52%) patients. Mortality was 14%. At follow-up, 88% of patients showed complete eradication of the SV infection. Conclusions Upper gastrointestinal biopsy positive for SV should prompt an evaluation of the clinical conditions, being the risk of gastric perforation not negligible. Antibiotic therapy may eradicate the infection and prevent complications. Emergency surgery is required in case of source control.

Published
2021

47. NAFLD-Related Hepatocarcinoma: The Malignant Side of Metabolic Syndrome

Author

Michela Guardascione, Rossana Roncato, L. Palmero, A. Michelotti, Elena Ongaro, Luisa Foltran, Fabio Puglisi, Marco de Scordilli, and Mario Masala

Subjects
Oncology, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, QH301-705.5, Disease, Review, digestive system, metabolic syndrome, Non-alcoholic Fatty Liver Disease, Internal medicine, NAFLD, insulin resistance, medicine, Humans, HCC, Biology (General), Inflammation, business.industry, Fatty liver, Liver Neoplasms, NASH, Cancer, nutritional and metabolic diseases, General Medicine, hepatocellular carcinoma, medicine.disease, digestive system diseases, Clinical trial, Hepatocellular carcinoma, Disease Progression, Steatohepatitis, Metabolic syndrome, business
Abstract

Hepatocellular carcinoma (HCC) is the seventh most common cancer worldwide and the second leading cause of cancer-related mortality. HCC typically arises within a cirrhotic liver, but in about 20% of cases occurs in absence of cirrhosis. Among non-cirrhotic risk factors, non-alcoholic fatty liver disease (NAFLD) currently represents the most important emerging cause of HCC in developed countries. It has been estimated that annual incidence of HCC among patients with non-cirrhotic NAFLD is approximately 0.1–1.3 per 1000 patients/year and ranges from 0.5% to 2.6% among patients with non-alcoholic steatohepatitis (NASH) cirrhosis. However, only a few clinical trials enrolling HCC patients actually distinguished NAFLD/NASH-related cases from other non-cirrhotic causes and therefore evidence is still lacking in this subset of patients. This review aims to describe the biology underpinning NAFLD development, to investigate the main molecular pathways involved in its progression to NASH and HCC and to describe how different pathogenetic mechanisms underlying the onset of HCC can have an impact in clinical practice. We hereby also provide an overview of current HCC treatment options, with a particular focus on the available data on NAFLD-related cases in practice-changing clinical trials.

Published
2021

48. Chronic Isolation Stress Affects Central Neuroendocrine Signaling Leading to a Metabolically Active Microenvironment in a Mouse Model of Breast Cancer

Author

Sara Capoccia, Francesca Cirulli, Barbara Collacchi, Giada Pontecorvi, Rossella Puglisi, Carla Raggi, Maria Teresa D'Urso, Elena Ortona, Eleonora Aricò, Serena Cecchetti, Alessandra Berry, and Paola Sestili

Subjects
0301 basic medicine, medicine.medical_specialty, mouse model, Cognitive Neuroscience, social isolation stress, Adipokine, Neurosciences. Biological psychiatry. Neuropsychiatry, leptin, Energy homeostasis, NPY/AgRP, 03 medical and health sciences, Behavioral Neuroscience, chemistry.chemical_compound, breast cancer, 0302 clinical medicine, Corticosterone, Neurotrophic factors, Internal medicine, Brown adipose tissue, medicine, Original Research, Adiponectin, business.industry, HPA axis, Leptin, brown adipose tissue, Neuropeptide Y receptor, 030104 developmental biology, Neuropsychology and Physiological Psychology, medicine.anatomical_structure, Endocrinology, chemistry, depression, business, 030217 neurology & neurosurgery, RC321-571
Abstract

Social isolation is a powerful stressor capable of affecting brain plasticity and function. In the case of breast cancer, previous data indicate that stressful experiences may contribute to a worse prognosis, activating neuroendocrine and metabolism pathways, although the mechanisms underlying these effects are still poorly understood. In this study, we tested the hypothesis that chronic isolation stress (IS) may boost hypothalamic–pituitary–adrenal (HPA) axis activity, leading to changes in the hypothalamic expression of genes modulating both mood and metabolism in an animal model of breast cancer. This centrally activated signaling cascade would, in turn, affect the mammary gland microenvironment specifically targeting fat metabolism, leading to accelerated tumor onset. MMTVNeuTg female mice (a model of breast cancer developing mammary hyperplasia at 5 months of age) were either group-housed (GH) or subjected to IS from weaning until 5 months of age. At this time, half of these subjects underwent acute restraint stress to assess corticosterone (CORT) levels, while the remaining subjects were characterized for their emotional profile in the forced swimming and saccharin preference tests. At the end of the procedures, all the mice were sacrificed to assess hypothalamic expression levels of Brain-derived neurotrophic factor (Bdnf), Neuropeptide Y (NpY), Agouti-Related Peptide (AgRP), and Serum/Glucocorticoid-Regulated Protein Kinase 1 (SgK1). Leptin and adiponectin expression levels, as well as the presence of brown adipose tissue (BAT), were assessed in mammary fat pads. The IS mice showed higher CORT levels following acute stress and decreased expression of NpY, AgRP, and SgK1, associated with greater behavioral despair in the forced swimming test. Furthermore, they were characterized by increased consumption of saccharin in a preference test, suggesting an enhanced hedonic profile. The IS mice also showed an earlier onset of breast lumps (assessed by palpation) accompanied by elevated levels of adipokines (leptin and adiponectin) and BAT in the mammary fat pads. Overall, these data point to IS as a pervasive stressor that is able to specifically target neuronal circuits, mastered by the hypothalamus, modulating mood, stress reactivity and energy homeostasis. The activation of such IS-driven machinery may hold main implications for the onset and maintenance of pro-tumorigenic environments.

Published
2021

49. Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Author

Dirk Klingbiel, Thomas Bachelot, David Miles, Shani Paluch-Shimon, Eva Ciruelos, J-L Merot, Andreas Schneeweiss, M. Campone, Y. du Toit, Hassan Errihani, Andrew M Wardley, Fabio Puglisi, I. Bondarenko, Zbigniew Nowecki, T. Peretz-Yablonski, and V. Revelant

Subjects
Oncology, medicine.medical_specialty, Taxane, First line therapy, business.industry, Trastuzumab, Internal medicine, medicine, Pertuzumab, medicine.disease, business, Metastatic breast cancer, medicine.drug
Published
2021

50. Mitotane: new facts for an old drug

Author

Soraya Puglisi, Vittoria Basile, Massimo Terzolo, Paola Perotti, and Anna Calabrese

Subjects
0301 basic medicine, Drug, Oncology, medicine.medical_specialty, Chemotherapy, business.industry, Endocrinology, Diabetes and Metabolism, media_common.quotation_subject, medicine.medical_treatment, 030209 endocrinology & metabolism, Disease, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Internal medicine, Medicine, Adrenocortical carcinoma, Endocrine effects, Mitotane, Radical surgery, business, Adjuvant, media_common, medicine.drug
Abstract

Adrenocortical carcinoma (ACC) is an aggressive cancer with poor long-term survival. Apart from radical surgery, there is a reduced range of therapeutic possibilities, and mitotane remains the cornerstone of the treatment in the adjuvant and palliative setting. Although many decades after its introduction in clinical practice, there are still many uncertainties surrounding the applied use and the actual benefit of this old drug. Recent adrenocortical carcinoma guidelines suggest adjuvant mitotane for patients at high risk of recurrence and chemotherapy plus mitotane for metastatic disease; moreover, the use of mitotane monotherapy has been proposed in a subset of patients. When using mitotane, physicians have to consider and manage its potential toxicity and endocrine effects that need a complex supporting therapy.

Published
2019

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