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1. Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS)

Author

Mercadante, Sebastiano, Marchetti, Paolo, Cuomo, Arturo, Caraceni, Augusto, Mediati, Rocco Domenico, Mammucari, Massimo, Natoli, Silvia, Lazzari, Marzia, Dauri, Mario, Airoldi, Mario, Azzarello, Giuseppe, Bandera, Mauro, Blasi, Livio, Cartenì, Giacomo, Chiurazzi, Bruno, Costanzo, Benedetta Veruska Pierpaola, Degiovanni, Daniela, Fusco, Flavio, Guardamagna, Vittorio, Iaffaioli, Vincenzo, Liguori, Simeone, Lorusso, Vito, Mameli, Sergio, Mattioli, Rodolfo, Mazzei, Teresita, Menardo, Valentino, Miotti, Danilo, Moroso, Stefano, De Santis, Stefano, Orsetti, Remo, Papa, Alfonso, Ricci, Sergio, Sabato, Alessandro Fabrizio, Scelzi, Elvira, Sofia, Michele, Tonini, Giuseppe, Aielli, Federica, Valle, Alessandro, Caruselli, Amanda, Prestia, Giovanna, Giusti, Raffaele, Costanzi, Andrea, Angelini, Silvia, Iacono, Daniela, Mazzuca, Federica, Carnevale, Alessia, Bonome, Paolo, Nicosia, Luca, Scaringi, Claudia, Montalto, Adelaide, Russo, Gennaro, Forte, Cira Antonietta, Esposito, Gennaro, Bracchi, Paola, Zecca, Ernesto, Campa, Tiziana, Grecchi, Silvia, Pigni, Alessandra, Sammaro, Annunziata, Dodaro, Lucia, Ballerini, Giovanna, Vellucci, Renato, Caldarulo, Clarissa, Palombo, Elisa, Diviza, Marco, Gianfelice, Valentina, Silvestri, Claudia, Finocchi, Simona, Contu, Viviana, Fora, Gianluca, Pedani, Fulvia, Icardi, Massimiliano, Bellini, Elisa, Celano, Alfredo, Berardo, Roberto, Ostellino, Oliviero, Sartori, Kayta, Demartini, Paola, Scroccaro, Raffaella, Boscolo, Giorgia, Sartori, Donata, Rosetti, Francesco, Artioli, Grazia, Borgato, Lucia, Bertoldero, Giovanni, Veronese, Barbara, Vallini, Ilaria, Tuzi, Alessandro, Bolzacchini, Elena, Pinotti, Graziella, Alù, Massimiliano, Usset, Antonella, Arcuri, Carmela, Laudani, Agata, Pepe, Alessio, Scagliarini, Sarah, Sgarlata, Massimiliano Savio Maria, Raimondi, Massimo, Valenti, Salvatore Maria Giovanni, Bucceri, Alberto, Kasa, Alma, Budel, Paola, Caramellino, Anna, Ballarino, Paola, Donelli, Emanuela, Silvestro, Stefania, Tonetti, Rossella, Bozzoni, Samuela, Cocquio, Angela, Romano, Carmela, Nappi, Anna, Silvestro, Lucrezia, De Divitiis, Chiara, Ghidoni, Silvia, Cortinovis, Rosalba, Marchesi, Roberta, Fortis, Michele, Palermo, Loredana, Pisanu, Giovanni Maria, Carboni, Maura, Meloni, Francesca, Barillari, Daniele, Imperatori, Luca, Grilli, Gianni, Laici, Gianluca, Diacciati, Sara, Petreni, Paolo, Marsigli, Federica, Manfreda, Miriam, Ghedini, Silvia, Bruno, Emanuela, Salvini, Emanuele, Gerboni, Davide, Saulle, Serena, Carella, Roberta, Pascoletti, Gaetano, Bolzonello, Silvia, Bonotto, Marta, Ellero, Silvia, Fasola, Gianpiero, Ongaro, Elena, Borghesi, Cristina, Germani, Lucia, De Ruvo, Edoardo, Marchetti, Federica, Pasquale, Milena, Masu, Lucia, Tammaro, Dario, Saracco, Elisabetta, Di Dato, Maria Teresa, Ferrara, Maurizio, Pironti, Andrea, Buonavolontà, Pietro, Ginocchi, Laura, Musettini, Gianna, Antonuzzo, Andrea, Caparello, Chiara, Lucchesi, Maurizio, Farnesi, Azzurra, Zampieri, Mari, Pisciotta, Manuela, Fioroni, Iacopo, Ratta, Raffaele, Cursano, Maria Concetta, Santini, Daniele, Potestà, Cinzia, Gallo, Gloria, Saber, Benhaz, MELOTTI, RITA MARIA, SAMOLSKY DEKEL, BOAZ GEDALIAHU, Mercadante, Sebastiano, Marchetti, Paolo, Cuomo, Arturo, Caraceni, Augusto, Mediati, Rocco Domenico, Mammucari, Massimo, Natoli, Silvia, Lazzari, Marzia, Dauri, Mario, Airoldi, Mario, Azzarello, Giuseppe, Bandera, Mauro, Blasi, Livio, Cartenì, Giacomo, Chiurazzi, Bruno, Costanzo, Benedetta Veruska Pierpaola, Degiovanni, Daniela, Fusco, Flavio, Guardamagna, Vittorio, Iaffaioli, Vincenzo, Liguori, Simeone, Lorusso, Vito, Mameli, Sergio, Mattioli, Rodolfo, Mazzei, Teresita, Melotti, Rita Maria, Menardo, Valentino, Miotti, Danilo, Moroso, Stefano, De Santis, Stefano, Orsetti, Remo, Papa, Alfonso, Ricci, Sergio, Sabato, Alessandro Fabrizio, Scelzi, Elvira, Sofia, Michele, Tonini, Giuseppe, Aielli, Federica, Valle, Alessandro, Caruselli, Amanda, Prestia, Giovanna, Giusti, Raffaele, Costanzi, Andrea, Angelini, Silvia, Iacono, Daniela, Mazzuca, Federica, Carnevale, Alessia, Bonome, Paolo, Nicosia, Luca, Scaringi, Claudia, Montalto, Adelaide, Russo, Gennaro, Forte, Cira Antonietta, Esposito, Gennaro, Bracchi, Paola, Zecca, Ernesto, Campa, Tiziana, Grecchi, Silvia, Pigni, Alessandra, Sammaro, Annunziata, Dodaro, Lucia, Ballerini, Giovanna, Vellucci, Renato, Caldarulo, Clarissa, Palombo, Elisa, Diviza, Marco, Gianfelice, Valentina, Silvestri, Claudia, Finocchi, Simona, Contu, Viviana, Fora, Gianluca, Pedani, Fulvia, Icardi, Massimiliano, Bellini, Elisa, Celano, Alfredo, Berardo, Roberto, Ostellino, Oliviero, Sartori, Kayta, Demartini, Paola, Scroccaro, Raffaella, Boscolo, Giorgia, Sartori, Donata, Rosetti, Francesco, Artioli, Grazia, Borgato, Lucia, Bertoldero, Giovanni, Veronese, Barbara, Vallini, Ilaria, Tuzi, Alessandro, Bolzacchini, Elena, Pinotti, Graziella, Alù, Massimiliano, Usset, Antonella, Arcuri, Carmela, Laudani, Agata, Pepe, Alessio, Scagliarini, Sarah, Sgarlata, Massimiliano Savio Maria, Raimondi, Massimo, Valenti, Salvatore Maria Giovanni, Bucceri, Alberto, Kasa, Alma, Budel, Paola, Caramellino, Anna, Ballarino, Paola, Donelli, Emanuela, Silvestro, Stefania, Tonetti, Rossella, Bozzoni, Samuela, Cocquio, Angela, Romano, Carmela, Nappi, Anna, Silvestro, Lucrezia, De Divitiis, Chiara, Ghidoni, Silvia, Cortinovis, Rosalba, Marchesi, Roberta, Fortis, Michele, Palermo, Loredana, Pisanu, Giovanni Maria, Carboni, Maura, Meloni, Francesca, Barillari, Daniele, Imperatori, Luca, Grilli, Gianni, Laici, Gianluca, Diacciati, Sara, Petreni, Paolo, Samolsky Dekel, Boaz, Marsigli, Federica, Manfreda, Miriam, Ghedini, Silvia, Bruno, Emanuela, Salvini, Emanuele, Gerboni, Davide, Saulle, Serena, Carella, Roberta, Pascoletti, Gaetano, Bolzonello, Silvia, Bonotto, Marta, Ellero, Silvia, Fasola, Gianpiero, Ongaro, Elena, Borghesi, Cristina, Germani, Lucia, De Ruvo, Edoardo, Marchetti, Federica, Pasquale, Milena, Masu, Lucia, Tammaro, Dario, Saracco, Elisabetta, Di Dato, Maria Teresa, Ferrara, Maurizio, Pironti, Andrea, Buonavolontà, Pietro, Ginocchi, Laura, Musettini, Gianna, Antonuzzo, Andrea, Caparello, Chiara, Lucchesi, Maurizio, Farnesi, Azzurra, Zampieri, Mari, Pisciotta, Manuela, Fioroni, Iacopo, Ratta, Raffaele, Cursano, Maria Concetta, Santini, Daniele, Potestà, Cinzia, Gallo, Gloria, and Saber, Benhaz

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/06 - Oncologia Medica, Pain assessment, Breakthrough pain, Cancer pain, Rapid-onset opioid, Settore MED/41 - Anestesiologia, 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, Rating scale, Surveys and Questionnaires, Internal medicine, Epidemiology, medicine, Humans, Pain Management, Pharmacology (medical), Stage (cooking), Aged, Pain Measurement, Original Research, Medicine(all), business.industry, Medicine (all), General Medicine, Middle Aged, Rheumatology, Analgesics, Opioid, Italy, Opioid, Patient Satisfaction, 030220 oncology & carcinogenesis, Physical therapy, Female, business, Algorithms, 030217 neurology & neurosurgery, medicine.drug
Abstract

Introduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here. Methods: Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity. Results: Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids. Conclusions: These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients’ satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients. Funding: Molteni Farmaceutici, Italy.

Published
2017

3. Modeling the Prognostic Impact of Circulating Tumor Cells Enumeration in Metastatic Breast Cancer for Clinical Trial Design Simulation

Author

Lorenzo Gerratana, Jean-Yves Pierga, James M Reuben, Andrew A Davis, Firas H Wehbe, Luc Dirix, Tanja Fehm, Franco Nolé, Rafael Gisbert-Criado, Dimitrios Mavroudis, Salvatore Grisanti, Jose A Garcia-Saenz, Justin Stebbing, Carlos Caldas, Paola Gazzaniga, Luis Manso, Rita Zamarchi, Marta Bonotto, Angela Fernandez de Lascoiti, Leticia De Mattos-Arruda, Michail Ignatiadis, Maria-Teresa Sandri, Daniele Generali, Carmine De Angelis, Sarah-Jane Dawson, Wolfgang Janni, Vicente Carañana, Sabine Riethdorf, Erich-Franz Solomayer, Fabio Puglisi, Mario Giuliano, Klaus Pantel, François-Clément Bidard, Massimo Cristofanilli, Gerratana, Lorenzo, Pierga, Jean-Yve, Reuben, James M, Davis, Andrew A, Wehbe, Firas H, Dirix, Luc, Fehm, Tanja, Nolé, Franco, Gisbert-Criado, Rafael, Mavroudis, Dimitrio, Grisanti, Salvatore, Garcia-Saenz, Jose A, Stebbing, Justin, Caldas, Carlo, Gazzaniga, Paola, Manso, Lui, Zamarchi, Rita, Bonotto, Marta, Fernandez de Lascoiti, Angela, De Mattos-Arruda, Leticia, Ignatiadis, Michail, Sandri, Maria-Teresa, Generali, Daniele, De Angelis, Carmine, Dawson, Sarah-Jane, Janni, Wolfgang, Carañana, Vicente, Riethdorf, Sabine, Solomayer, Erich-Franz, Puglisi, Fabio, Giuliano, Mario, Pantel, Klau, Bidard, François-Clément, Cristofanilli, Massimo, Institut Català de la Salut, [Gerratana L] Department of Medical Oncology, Centro di Riferimento Oncologico (CRO), IRCCS, Aviano (PN), Italy. [Pierga JY] Department of Medical Oncology, Institut Curie, Paris & Saint-Cloud, Paris University, Paris, France. [Reuben JM] Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. [Davis AA] Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Department of Medicine, Division of Oncology, Washington University School of Medicine in St. Louis, MO, USA. [Wehbe FH] Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. [Dirix L] Translational Cancer Research Unit, GZA Hospitals Sint-Augustinus, Antwerp, Belgium. [De Mattos-Arruda L] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Cancer Research, Mama - Càncer - Prognosi, K-nearest neighbor, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Neoplasms::Neoplastic Processes::Neoplasm Metastasis::Neoplastic Cells, Circulating [DISEASES], biomarker, clinical trial model, liquid biopsy, machine learning, Breast Neoplasms, Information Science::Computing Methodologies::Computer Simulation [INFORMATION SCIENCE], Simulació per ordinador, Ciencias de la información::metodologías computacionales::simulación por ordenador [CIENCIA DE LA INFORMACIÓN], Biomarkers, Tumor, Humans, Computer Simulation, Retrospective Studies, neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], Clinical Trials as Topic, Liver Neoplasms, Neoplastic Cells, Circulating, Prognosis, Oncology, neoplasias::procesos neoplásicos::metástasis neoplásica::células neoplásicas circulantes [ENFERMEDADES], Cèl·lules canceroses, Female
Abstract

Biomarker; Liquid biopsy; Machine learning Biomarcadores; Biopsia líquida; Aprendizaje automático Biomarcadors; Biòpsia líquida; Aprenentatge automàtic Despite the strong prognostic stratification of circulating tumor cells (CTCs) enumeration in metastatic breast cancer (MBC), current clinical trials usually do not include a baseline CTCs in their design. This study aimed to generate a classifier for CTCs prognostic simulation in existing datasets for hypothesis generation in patients with MBC. A K-nearest neighbor machine learning algorithm was trained on a pooled dataset comprising 2436 individual MBC patients from the European Pooled Analysis Consortium and the MD Anderson Cancer Center to identify patients likely to have CTCs ≥ 5/7 mL blood (StageIVaggressive vs StageIVindolent). The model had a 65.1% accuracy and its prognostic impact resulted in a hazard ratio (HR) of 1.89 (Simulatedaggressive vs SimulatedindolentP < .001), similar to patients with actual CTCs enumeration (HR 2.76; P < .001). The classifier’s performance was then tested on an independent retrospective database comprising 446 consecutive hormone receptor (HR)-positive HER2-negative MBC patients. The model further stratified clinical subgroups usually considered prognostically homogeneous such as patients with bone-only or liver metastases. Bone-only disease classified as Simulatedaggressive had a significantly worse overall survival (OS; P < .0001), while patients with liver metastases classified as Simulatedindolent had a significantly better prognosis (P < .0001). Consistent results were observed for patients who had undergone CTCs enumeration in the pooled population. The differential prognostic impact of endocrine- (ET) and chemotherapy (CT) was explored across the simulated subgroups. No significant differences were observed between ET and CT in the overall population, both in terms of progression-free survival (PFS) and OS. In contrast, a statistically significant difference, favoring CT over ET was observed among Simulatedaggressive patients (HR: 0.62; P = .030 and HR: 0.60; P = .037, respectively, for PFS and OS). The study was supported by Lynn Sage Cancer Research Foundation and the the CRO Aviano 5x1000 2014 per la Ricerca Sanitaria, Cancer Specific Intramural Grant. The funding sources had no role in the study design, data collection, data analysis, interpretation, or writing of the manuscript.

Published
2022

4. 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
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5. Chemotherapy versus endocrine therapy as first-line treatment in patients with luminal-like HER2-negative metastatic breast cancer: A propensity score analysis

Author

Grazia Arpino, Fabio Puglisi, Marta Bonotto, Massimo Di Maio, Gianpiero Fasola, Lorenzo Gerratana, S. Moroso, Mauro Mansutti, Sabino De Placido, Donatella Iacono, Monica Milano, Carmine De Angelis, Marika Cinausero, Brigida Stanzione, Alessandro Marco Minisini, Piera Gargiulo, Bonotto, Marta, Gerratana, Lorenzo, Di Maio, Massimo, DE ANGELIS, Carmine, Cinausero, Marika, Moroso, Stefano, Milano, Monica, Stanzione, Brigida, Gargiulo, Piera, Iacono, Donatella, Minisini, Alessandro Marco, Mansutti, Mauro, Fasola, Gianpiero, DE PLACIDO, Sabino, Arpino, Grazia, and Puglisi, Fabio

Subjects
0301 basic medicine, Oncology, Multivariate analysis, Receptor, ErbB-2, medicine.medical_treatment, Hormone antagonist, Antineoplastic Agent, Metastatic breast neoplasms, 0302 clinical medicine, Retrospective Studie, Age Factor, Metastatic breast neoplasm, Neoplasm Metastasis, Treatment outcome, Multivariate Analysi, Chemotherapy, Decision making, Drug therapy, education.field_of_study, Age Factors, General Medicine, Middle Aged, Metastatic breast cancer, Neoplasm Metastasi, 030220 oncology & carcinogenesis, Female, Breast Neoplasm, Human, medicine.medical_specialty, Population, Antineoplastic Agents, Breast Neoplasms, Disease-Free Survival, 03 medical and health sciences, Hormone Antagonists, Pharmacotherapy, Internal medicine, medicine, Humans, Propensity Score, education, Aged, Retrospective Studies, business.industry, Retrospective cohort study, medicine.disease, Surgery, Hormone Antagonist, 030104 developmental biology, Multivariate Analysis, Propensity score matching, business
Abstract

Background According to current guidelines, endocrine therapy (ET) is recommended as first-line treatment of luminal-like metastatic breast cancer (MBC), whereas chemotherapy (CT) should be considered in presence of life-threatening disease. In daily practice, CT is often used outside of this clinical circumstance. Factors influencing first-line choice and the relative impact on outcome are unknown. Methods A consecutive series of luminal-like HER2-negative MBC patients treated from 2004 to 2014 was analyzed to test the association of disease- and patient-related factors with the choice of first-line treatment (ET vs. CT). A propensity score method was used to estimate impact of first-line strategy on outcome. Results Of 604 consecutive luminal-like MBC patients identified, 158 cases were excluded due to unknown or positive HER2-status. Among 446 HER2-negative cases, 171 (38%) received first-line CT. On multivariate analysis, the only factors significantly associated with lower CT use were old age (OR 0.25, 95%C.I. 0.13–0.49) or presence of bone metastases only (OR 0.26, 95%C.I. 0.13–0.53). In propensity score matched population, no differences were observed between CT and ET as first-line treatment either in terms of overall survival (37.5 months and 33.4 months respectively, log-rank test, P = 0.62) or progression-free survival (13.3 months and 9.9 months respectively, log-rank test, P = 0.92). Conclusions High percentage of patients with luminal-like MBC received CT as first-line therapy in real-life. The choice was mainly driven by age and site of metastases. With the limitations of a non-randomized comparison, no differences on patients' outcome were observed depending on the first-line strategy.

Published
2017
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6. Luminal-like HER2-negative stage IA breast cancer: a multicenter retrospective study on long-term outcome with propensity score analysis

Author

Mario Giuliano, Lorenzo Gerratana, Ferdinando Riccardi, Carmine De Angelis, Marta Bonotto, Massimo Di Maio, Giuseppe Ciancia, Francesco Schettini, Sabino De Placido, Marika Cinausero, Fabio Puglisi, Anna Crispo, Michelino De Laurentiis, Grazia Arpino, Donatella Iacono, De Angelis, Carmine, Di Maio, Massimo, Crispo, Anna, Giuliano, Mario, Schettini, Francesco, Bonotto, Marta, Gerratana, Lorenzo, Iacono, Donatella, Cinausero, Marika, Riccardi, Ferdinando, Ciancia, Giuseppe, De Laurentiis, Michelino, Puglisi, Fabio, De Placido, Sabino, and Arpino, Grazia

Subjects
Oncology, medicine.medical_specialty, Propensity score, medicine.medical_treatment, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Internal medicine, medicine, Adjuvant therapy, Chemotherapy, 030212 general & internal medicine, Stage (cooking), Hormone therapy, Cancer staging, Univariate analysis, business.industry, Retrospective cohort study, medicine.disease, Luminal-like, 030220 oncology & carcinogenesis, Propensity score matching, business, Research Paper
Abstract

The benefit of adding chemotherapy (CT) to adjuvant hormone therapy (HT) in stage IA luminal-like HER2-negative breast cancer (BC) is unclear. We retrospectively evaluated predictive factors and clinical outcome of 1,222 patients from 4 oncologic centers. Three hundred and eighty patients received CT and HT (CT-cohort) and 842 received HT alone (HT-cohort). Disease-free survival (DFS) and overall survival (OS) were evaluated with univariate and multivariate analyses. We also applied the propensity score methodology. Compared with the HT-cohort, patients in the CT-cohort were more likely to be younger, have larger tumors of a higher histological grade that were Ki67-positive, and lower estrogen and progesterone receptor expression. At univariate analysis, a higher histological grade and Ki67 were significantly associated to a lower DFS. At multivariable analysis, only histological grade was predictive of DFS. The CT-cohort had a worse outcome than the HT-cohort in terms of DFS and OS, but differences disappeared when matched according to propensity score. In summary, patients with stage IA luminal-like BC had an excellent prognosis, however relapse and mortality were higher in the CT-cohort than in the HT-cohort. Longer use of adjuvant HT or other therapeutic strategies may be needed to improve outcome.

Published
2017

7. Immunotherapy for colorectal cancer: where are we heading?

Author

Elisa De Carlo, Francesca Negri, Marta Bonotto, Valentina Fanotto, Marco Puzzoni, Mariaelena Casagrande, Debora Basile, Elena Ongaro, Fotios Loupakis, Monica Cattaneo, Oronzo Brunetti, Mario Scartozzi, Lorenzo Calvetti, Nicola Silvestris, Marco Russano, Nadia Cardarelli, Federica Urbano, Giuseppe Aprile, Silvio Garattini, Nicoletta Pella, Andrea Casadei Gardini, Daniele Santini, Basile, Debora, Garattini, Silvio Ken, Bonotto, Marta, Ongaro, Elena, Casagrande, Mariaelena, Cattaneo, Monica, Fanotto, Valentina, De Carlo, Elisa, Loupakis, Fotio, Urbano, Federica, Negri, Francesca V., Pella, Nicoletta, Russano, Marco, Brunetti, Oronzo, Scartozzi, Mario, Santini, Daniele, Silvestris, Nicola, Casadei Gardini, Andrea, Puzzoni, Marco, Calvetti, Lorenzo, Cardarelli, Nadia, and Aprile, Giuseppe

Subjects
0301 basic medicine, Oncology, atezolizumab, PD-L1, medicine.medical_specialty, Colorectal cancer, medicine.medical_treatment, T-Lymphocytes, Clinical Biochemistry, Antineoplastic Agents, colorectal cancer, Pembrolizumab, Mesenchymal Stem Cell Transplantation, 03 medical and health sciences, 0302 clinical medicine, Immune system, Atezolizumab, Internal medicine, Drug Discovery, medicine, Tumor Microenvironment, Humans, CTLA-4 Antigen, MSI, Pharmacology, biology, business.industry, Drug Discovery3003 Pharmaceutical Science, Antibodies, Monoclonal, Mesenchymal Stem Cells, Immunotherapy, medicine.disease, Prognosis, Clinical trial, 030104 developmental biology, 030220 oncology & carcinogenesis, Immunology, Cancer cell, pembrolizumab, biology.protein, immunotherapy, Drug Therapy, Combination, business, Colorectal Neoplasms
Abstract

Introduction: In the last few years, significant advances in molecular biology have provided new therapeutic options for colorectal cancer (CRC). The development of new drugs that target the immune response to cancer cells seems very promising and has already been established for other tumor types. In particular, the use of immune checkpoint inhibitors seems to be an encouraging immunotherapeutic strategy. Areas covered: In this review, the authors provide an update of the current evidence related to this topic, though most immunotherapies are still in early-phase clinical trials for CRC. To understand the key role of immunotherapy in CRC, the authors discuss the delicate balance between immune-stimulating and immune-suppressive networks that occur in the tumor microenvironment. Expert opinion: Modulation of the immune system through checkpoint inhibition is an emerging approach in CRC therapy. Nevertheless, selection criteria that could enable the identification of patients who may benefit from these agents are necessary. Furthermore, potential prognostic and predictive immune biomarkers based on immune and molecular classifications have been proposed. As expected, additional studies are required to develop biomarkers, effective therapeutic strategies and novel combinations to overcome immune escape resistance and enhance effector response.

Published
2017

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