112 results on '"Balduzzi, S"'
Search Results
2. Predictive Role Of Body Composition Parameters In Operable Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
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Omarini C, Palumbo P, Pecchi A, Draisci S, Balduzzi S, Nasso C, Barbolini M, Isca C, Bocconi A, Moscetti L, Galetti S, Tazzioli G, Torricelli P, Cascinu S, and Piacentini F
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bmi ,fat tissue ,sarcopenia ,pathological complete response ,breast cancer ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Claudia Omarini,1 Patrizia Palumbo,2 Annarita Pecchi,3 Stefano Draisci,3 Sara Balduzzi,4 Cecilia Nasso,1 Monica Barbolini,1 Chrystel Isca,1 Alessandro Bocconi,1 Luca Moscetti,1 Silvia Galetti,5 Giovanni Tazzioli,6 Pietro Torricelli,3 Stefano Cascinu,1 Federico Piacentini1 1Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 2Division of Clinical Nutrition and Metabolism, Department of Specialist Medicines, University Hospital of Modena, Modena, Italy; 3Department of Radiology, University Hospital of Modena, Modena, Italy; 4Statistics Unit, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 5Division of Clinical Nutrition and Metabolism, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 6Department of General Surgery and Surgical Specialities, University Hospital of Modena, Modena, ItalyCorrespondence: Claudia OmariniDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Via Del Pozzo 71, Modena 41122, ItalyTel +39 059 4222845Email claudia.omarini@gmail.comBackground: Fat tissue is strongly involved in BC tumorigenesis inducing insulin resistance, chronic inflammation and hormonal changes. Computed tomography (CT) imaging instead of body mass index (BMI) gives a reliable measure of skeletal muscle mass and body fat distribution. The impact of body composition parameters (BCPs) on chemosensitivity is still debated. We examined the associations between BCPs and tumor response to neoadjuvant chemotherapy (NC) in patients treated for operable breast cancer (BC).Methods: A retrospective review of BC patients treated with NC in Modena Cancer Center between 2005 and 2017 was performed. BCPs, such as subcutaneous fat area (SFA), visceral fat area (VFA), lumbar skeletal muscle index (LSMI) and liver-to-spleen (L/S) ratio were calculated by Advance workstation (General Electric), software ADW server 3.2 or 4.7. BMI and BCPs were correlated with pathological complete response (pCR) and survival outcomes.Results: 407 patients were included in the study: 55% with BMI < 25 and 45% with BMI ≥ 25. 137 of them had pre-treatment CT scan imagines. Overweight was significantly associated with postmenopausal status and older age. Hormonal receptor positive BC was more frequent in overweight patients (p
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- 2019
3. Association of tumor-infiltrating lymphocytes with distant disease-free survival in the ShortHER randomized adjuvant trial for patients with early HER2+ breast cancer
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Dieci, M.V., Conte, P., Bisagni, G., Brandes, A.A., Frassoldati, A., Cavanna, L., Musolino, A., Giotta, F., Rimanti, A., Garrone, O., Bertone, E., Cagossi, K., Sarti, S., Ferro, A., Piacentini, F., Maiorana, A., Orvieto, E., Sanders, M., Miglietta, F., Balduzzi, S., D’Amico, R., and Guarneri, V.
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- 2019
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4. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study
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Conte, P., Frassoldati, A., Bisagni, G., Brandes, A.A., Donadio, M., Garrone, O., Piacentini, F., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Molino, A., Musolino, A., Ferro, A., Maltoni, R., Danese, S., Zamagni, C., Rimanti, A., Cagossi, K., Russo, A., Pronzato, P., Giovanardi, F., Moretti, G., Lombardo, L., Schirone, A., Beano, A., Amaducci, L., Bajardi, E.A., Vicini, R., Balduzzi, S., D’Amico, R., and Guarneri, V.
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- 2018
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5. LBA31 Neoadjuvant nivolumab plus relatlimab (anti-LAG3) in locally advanced MMR-deficient colon cancers: The NICHE-3 study
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Verschoor, Y.L., primary, van den Berg, J., additional, Balduzzi, S., additional, van Blijderveen, J.C., additional, Oosterling, S., additional, Burger, P., additional, Aukema, T., additional, Vogten, T., additional, Dokter, S., additional, Beets-Tan, R., additional, Lent, A.V., additional, Beets, G., additional, van Leerdam, M., additional, Haanen, J.B.A.G., additional, and Chalabi, M., additional
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- 2023
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6. Induction therapy with ipilimumab and nivolumab followed by consolidative chemoradiation as organ-sparing treatment in urothelial bladder cancer: study protocol of the INDIBLADE trial
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Stockem, C.F., primary, Mellema, J.J.J., additional, van Rhijn, B.W.G., additional, Boellaard, T.N., additional, van Montfoort, M.L., additional, Balduzzi, S., additional, Boormans, J.L., additional, Franckena, M., additional, Meijer, R.P., additional, Robbrecht, D.G.J., additional, Suelmann, B.B.M., additional, Schaake, E.E., additional, and van der Heijden, M.S., additional
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- 2023
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7. Induction therapy with ipilimumab and nivolumab followed by consolidative chemoradiation as organ-sparing treatment in urothelial bladder cancer:study protocol of the INDIBLADE trial
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Stockem, C. F., Mellema, J. J.J., van Rhijn, B. W.G., Boellaard, T. N., van Montfoort, M. L., Balduzzi, S., Boormans, J. L., Franckena, M., Meijer, R. P., Robbrecht, D. G.J., Suelmann, B. B.M., Schaake, E. E., van der Heijden, M. S., Stockem, C. F., Mellema, J. J.J., van Rhijn, B. W.G., Boellaard, T. N., van Montfoort, M. L., Balduzzi, S., Boormans, J. L., Franckena, M., Meijer, R. P., Robbrecht, D. G.J., Suelmann, B. B.M., Schaake, E. E., and van der Heijden, M. S.
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Introduction: Studies that assessed the efficacy of pre-operative immune checkpoint blockade (ICB) in locally advanced urothelial cancer of the bladder showed encouraging pathological complete response rates, suggesting that a bladder-sparing approach may be a viable option in a subset of patients. Chemoradiation is an alternative for radical cystectomy with similar oncological outcomes, but is still mainly used in selected patients with organ-confined tumors or patients ineligible to undergo radical cystectomy. We propose to sequentially administer ICB and chemoradiation to patients with (locally advanced) muscle-invasive bladder cancer. Methods: The INDIBLADE trial is an investigator-initiated, single-arm, multicenter phase 2 trial. Fifty patients with cT2-4aN0-2M0 urothelial bladder cancer will be treated with ipilimumab 3 mg/kg on day 1, ipilimumab 3 mg/kg plus nivolumab 1 mg/kg on day 22, and nivolumab 3 mg/kg on day 43 followed by chemoradiation. The primary endpoint is the bladder-intact event-free survival (BI-EFS). Events include: local or distant recurrence, salvage cystectomy, death and switch to platinum-based chemotherapy. We will also evaluate the potential of multiparametric magnetic resonance imaging of the bladder to identify non-responders, and we will assess the clearance of circulating tumor DNA as a biomarker for ICB treatment response. Discussion: This is the first trial in which the efficacy of induction combination ICB followed by chemoradiation is being evaluated to provide bladder-preservation in patients with (locally advanced) urothelial bladder cancer. Clinical Trial Registration: The INDIBLADE trial was registered on clinicaltrials.gov on January 21, 2022 (NCT05200988).
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- 2023
8. Induction therapy with ipilimumab and nivolumab followed by consolidative chemoradiation as organ-sparing treatment in urothelial bladder cancer: study protocol of the INDIBLADE trial
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MS Urologische Oncologie, Cancer, MS Medische Oncologie, Stockem, C. F., Mellema, J. J.J., van Rhijn, B. W.G., Boellaard, T. N., van Montfoort, M. L., Balduzzi, S., Boormans, J. L., Franckena, M., Meijer, R. P., Robbrecht, D. G.J., Suelmann, B. B.M., Schaake, E. E., van der Heijden, M. S., MS Urologische Oncologie, Cancer, MS Medische Oncologie, Stockem, C. F., Mellema, J. J.J., van Rhijn, B. W.G., Boellaard, T. N., van Montfoort, M. L., Balduzzi, S., Boormans, J. L., Franckena, M., Meijer, R. P., Robbrecht, D. G.J., Suelmann, B. B.M., Schaake, E. E., and van der Heijden, M. S.
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- 2023
9. The impact of shift work on the psychological and physical health of nurses in a general hospital: a comparison between rotating night shifts and day shifts
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Ferri P, Guadi M, Marcheselli L, Balduzzi S, Magnani D, and Di Lorenzo R
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Shiftwork ,Night work ,Health ,Sleep disorders ,Job satisfaction ,Nurses ,Public aspects of medicine ,RA1-1270 - Abstract
Paola Ferri,1 Matteo Guadi,1 Luigi Marcheselli,1 Sara Balduzzi,1 Daniela Magnani,1 Rosaria Di Lorenzo2 1Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, 2Department of Mental Health, AUSL di Modena, Service of Psychiatric Diagnosis and Treatment, Modena, Italy Background: Shift work is considered necessary to ensure continuity of care in hospitals and residential facilities. In particular, the night shift is one of the most frequent reasons for the disruption of circadian rhythms, causing significant alterations of sleep and biological functions that can affect physical and psychological well-being and negatively impact work performance.Objectives: The aim of this study was to highlight if shift work with nights, as compared with day work only, is associated with risk factors predisposing nurses to poorer health conditions and lower job satisfaction.Methods: This cross-sectional study was conducted from June 1, 2015 to July 31, 2015 in 17 wards of a general hospital and a residential facility of a northern Italian city. This study involved 213 nurses working in rotating night shifts and 65 in day shifts. The instrument used for data collection was the “Standard Shift Work Index,” validated in Italian. Data were statistically analyzed.Results: The response rate was 86%. The nurses engaged in rotating night shifts were statistically significantly younger, more frequently single, and had Bachelors and Masters degrees in nursing. They reported the lowest mean score in the items of job satisfaction, quality and quantity of sleep, with more frequent chronic fatigue, psychological, and cardiovascular symptoms in comparison with the day shift workers, in a statistically significant way.Conclusion: Our results suggest that nurses with rotating night schedule need special attention due to the higher risk for both job dissatisfaction and undesirable health effects. Keywords: shift work, night work, health, sleep disorders, job satisfaction, nurses
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- 2016
10. 1780TiP A phase II clinical study to assess efficacy of induction ipilimumab/nivolumab to spare the bladder in urothelial bladder cancer (INDI-BLADE)
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Stockem, C.F., primary, van Rhijn, B.W.G., additional, Boellaard, T., additional, van Montfoort, M.L., additional, Balduzzi, S., additional, Boormans, J., additional, Franckena, M., additional, Meijer, R., additional, Noteboom, J., additional, Robbrecht, D., additional, Suelmann, B.B., additional, Schaake, E., additional, and van der Heijden, M.S., additional
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- 2022
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11. 1219P Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction (G/GEJ) adenocarcinoma: The PANDA study
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Chalabi, M., primary, Verschoor, Y.L., additional, Van De Haar, J., additional, van den Berg, J., additional, Kodach, L., additional, van Sandick, J., additional, van Dieren, J., additional, Balduzzi, S., additional, Grootscholten, M.C., additional, Veenhof, X., additional, Hartemink, K., additional, Vollebergh, M., additional, Owers, E., additional, Bartels-Rutten, A., additional, den Hartog-Lievaart, P., additional, van Leerdam, M., additional, Schumacher, T.N., additional, Haanen, J.B.A.G., additional, and Voest, E.E., additional
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- 2022
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12. Correspondence on 'EULAR December 2020 viewpoints on SARS-CoV-2 vaccination in patients with RMDs'
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Bugatti, S, Balduzzi, S, De Stefano, L, Manzo, A, Xoxi, B, Bogliolo, L, Monti, S, Delvino, P, Montecucco, C, Bugatti, S., Balduzzi, S., De Stefano, L., Manzo, A., Xoxi, B., Bogliolo, L., Monti, S., Delvino, P., Montecucco, C., Bugatti, S, Balduzzi, S, De Stefano, L, Manzo, A, Xoxi, B, Bogliolo, L, Monti, S, Delvino, P, Montecucco, C, Bugatti, S., Balduzzi, S., De Stefano, L., Manzo, A., Xoxi, B., Bogliolo, L., Monti, S., Delvino, P., and Montecucco, C.
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- 2021
13. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies
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Monti, S, Balduzzi, S, Delvino, P, Bellis, E, Quadrelli, V, Montecucco, C, Monti S., Balduzzi S., Delvino P., Bellis E., Quadrelli V. S., Montecucco C., Monti, S, Balduzzi, S, Delvino, P, Bellis, E, Quadrelli, V, Montecucco, C, Monti S., Balduzzi S., Delvino P., Bellis E., Quadrelli V. S., and Montecucco C.
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- 2020
14. 41O Nine weeks vs 1-year adjuvant trastuzumab: Long term outcomes of the ShortHER randomised trial
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Conte, P.F., primary, Frassoldati, A., additional, Bisagni, G., additional, Brandes, A.A., additional, Donadio, M., additional, Garrone, O., additional, Piacentini, F., additional, Cavanna, L., additional, Giotta, F., additional, Aieta, M., additional, Gebbia, V., additional, Musolino, A., additional, Ferro, A., additional, Danese, S., additional, Zamagni, C., additional, Nanni, O., additional, Dieci, M.V., additional, Vicini, R., additional, Balduzzi, S., additional, and Guarneri, V., additional
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- 2021
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15. Golimumab effectiveness in biologic inadequate responding patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis in real-life from the Italian registry GISEA
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Iannone, F., Favalli, E. G., Caporali, R., D'Angelo, S., Cantatore, F. P., Sarzi-Puttini, P., Foti, Roberta, Conti, Francesco, Carletto, A., Gremese, Elisa, Cauli, A., Ramonda, R., Palermo, A., Epis, O., Priora, M., Bergossi, F., Frediani, B., Salaffi, F., Lopalco, G., Cacciapaglia, F., Marchesoni, A., Biggioggiero, M., Bugatti, S., Balduzzi, S., Carriero, Alessandro, Corrado, A., Bongiovanni, S., Benenati, A., Miranda, F., Fracassi, E., Perra, D., Ferraccioli, Gianfranco, Lapadula, G., Foti R., Conti F., Gremese E. (ORCID:0000-0002-2248-1058), Carriero A., Ferraccioli G. (ORCID:0000-0001-6246-2428), Iannone, F., Favalli, E. G., Caporali, R., D'Angelo, S., Cantatore, F. P., Sarzi-Puttini, P., Foti, Roberta, Conti, Francesco, Carletto, A., Gremese, Elisa, Cauli, A., Ramonda, R., Palermo, A., Epis, O., Priora, M., Bergossi, F., Frediani, B., Salaffi, F., Lopalco, G., Cacciapaglia, F., Marchesoni, A., Biggioggiero, M., Bugatti, S., Balduzzi, S., Carriero, Alessandro, Corrado, A., Bongiovanni, S., Benenati, A., Miranda, F., Fracassi, E., Perra, D., Ferraccioli, Gianfranco, Lapadula, G., Foti R., Conti F., Gremese E. (ORCID:0000-0002-2248-1058), Carriero A., and Ferraccioli G. (ORCID:0000-0001-6246-2428)
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Objective: To evaluate the clinical effectiveness of golimumab in biologic inadequate responder (IR) patients with Rheumatoid arthritis (RA), Spondyloarthritis (SpA), and Psoriatic arthritis (PsA). Methods: We analyzed 1424 patients on golimumab from the GISEA registry. Drug survival was estimated by Kaplan-Meier analysis in biologic-naïve, 1-biologic IR, ≥ 2-biologics IR patients. Hazard ratios (HRs) of discontinuing golimumab at 2 years were assessed by multivariate Cox regression. Patients achieving CDAI based low disease activity (LDA) or BASDAI < 4 were calculated at 6 and 12 months. Results: In RA (n.370), the 2-years survival on golimumab was 61.4% in 1-biologic IR, 51.9% in ≥ 2-biologics IR, and 73.1% in biologic-naive patients (P = 0.002 vs ≥ 2-biologics IR). In SpA (n.502), the survival was similar among 1-biologic IR (80%), ≥ 2-biologics IR (76.5%), and biologic-naive (74.6%) patients (P > 0.05). In PsA (n.552) the survival was 72% in 1-biologic IR, 72.5% in ≥ 2-biologics IR, and 71.8% in naïve-biologic (P > 0.05). Predictors of golimumab discontinuation were monotherapy (HR 1.65) for RA, female gender for SpA (HR 2.48) and PsA (HR 1.57). In RA, patients on CDAI-LDA were lower in 1-biologic IR (40%) or ≥ 2 biologics IR (40%) than in biologic-naïve (60%) group at 6 months (P = 0.02), but no difference was observed at 12 months. In PsA and SpA, the percentage of patients on CDAI-LDA or BASDAI < 4 at 6 months was almost identical across the subgroups. Conclusions: Golimumab had similar effectiveness in biologic-failure and biologic-naïve SpA and PsA, but seems to be less effective in multi-failure RA patients, especially as monotherapy. The best outcomes were seen in male patients.
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- 2021
16. Introduction and methods of the evidence-based guidelines for the diagnosis and management of autism spectrum disorder by the Italian National Institute of Health
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Morgano, G. P., Fulceri, F., Nardocci, F., Barbui, C., Ostuzzi, G., Papola, D., Fatta, L. M., Fauci, A. J., Coclite, D., Napoletano, A., De Crescenzo, F., D'Alo, G. L., Amato, L., Cinquini, M., Iannone, P., Schunemann, H. J., Scattoni, M. L., Arduino, M., Bellosio, C., Biasci, S., Buono, S., Cappa, C., Cordo, C., Di Tommaso, E., Duff, C. M., Felici, C., Massagli, A., Molteni, M., Reali, L., Tancredi, R., Valeri, G., Venturini, L., Zuddas, A., Andreoli, M., Bergamin, C., Bertelli, M., Catania, D., Cavagnola, R., Cirrincione, P., Corti, S., Crognale, M., Faggioli, R., Giogoli, A. M., Grittani, S., Keller, R., Pace, P., Politi, P., Starace, F., Valenti, M., Balduzzi, S., Basile, M., Cruciani, F., D'Amico, R., Davoli, M., Lorenzo, M. G., Minozzi, S., Mitrova, Z., Moschetti, I., Pistotti, V., Saulle, R., and Vecchi, S.
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Adult ,Male ,Evidence-based practice ,Adolescent ,Autism Spectrum Disorder ,Psychological intervention ,Guideline ,Recommendations ,lcsh:Computer applications to medicine. Medical informatics ,03 medical and health sciences ,0302 clinical medicine ,Diagnosis ,medicine ,Humans ,030212 general & internal medicine ,Patient Reported Outcome Measures ,Autism Spectrum disorder ,GRADE approach ,Healthcare decision ,Italian National Institute of health ,Italian national guidelines system ,Treatment ,Grading (education) ,Child ,Medical education ,Evidence-Based Medicine ,Research ,Public Health, Environmental and Occupational Health ,Conflict of interest ,Stakeholder ,Italy ,Quality of Life ,Practice Guidelines as Topic ,General Medicine ,Evidence-based medicine ,medicine.disease ,Autism spectrum disorder ,ComputingMilieux_COMPUTERSANDSOCIETY ,lcsh:R858-859.7 ,Psychology ,030217 neurology & neurosurgery - Abstract
Background Autism Spectrum Disorder (ASD) is a neuro-developmental disorder that affects communication and behavior with a prevalence of approximately 1% worldwide. Health outcomes of interventions for ASD are largely Participant Reported Outcomes (PROs). Specific guidelines can help support the best care for people with ASD to optimize these health outcomes but they have to adhere to standards for their development to be trustworthy. Objective The goal of this article is to describe the new methodological standards of the Italian National Institute of Health and novel aspects of this guideline development process. This article will serve as a reference standard for future guideline development in the Italian setting. Methods We applied the new standards of the Italian National Institute of Health to the two guidelines on diagnosis and management of children/adolescents and adults with ASD, with a focus on the scoping, panel composition, management of conflict of interest, generation and prioritization of research questions, early stakeholders’ involvement, and PROs. Recommendations are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision frameworks. Results Following a public application process, the ISS established two multidisciplinary panels including people with ASD and/or their caregivers. Seventy-nine research questions were identified as potentially relevant for the guideline on children and adolescents with ASD and 31 for the one on adults with ASD. Questions deemed to have the highest priority were selected for inclusion in the guidelines. Other stakeholders valued their early involvement in the process which will largely focus on PROs. The panels then successfully piloted the development of recommendations using the methodological standards and process set by the ISS with a focus on PROs. Conclusions In this article, we describe the development of practice guidelines that focus on PROs for the diagnosis and management of ASD based on novel methods for question prioritization and stakeholder involvement. The recommendations allow for the adoption or adaptation to international settings.
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- 2020
17. Herbal supplements in pregnancy: unexpected results from a multicentre study
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Facchinetti, F., Pedrielli, G., Benoni, G., Joppi, M., Verlato, G., Dante, G., Balduzzi, S., and Cuzzolin, L.
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- 2012
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18. Clinical follow-up predictors of disease pattern change in anti-Jo1 positive anti-synthetase syndrome: Results from a multicenter, international and retrospective study
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Bartoloni, E, Gonzalez-Gay, M, Scire, C, Castaneda, S, Gerli, R, Lopez-Longo, F, Martinez-Barrio, J, Govoni, M, Furini, F, Pina, T, Iannone, F, Giannini, M, Nuno, L, Quartuccio, L, Ortego-Centeno, N, Alunno, A, Specker, C, Montecucco, C, Triantafyllias, K, Balduzzi, S, Sifuentes-Giraldo, W, Paolazzi, G, Bravi, E, Schwarting, A, Pellerito, R, Russo, A, Selmi, C, Saketkoo, L, Fusaro, E, Parisi, S, Pipitone, N, Franceschini, F, Cavazzana, I, Neri, R, Barsotti, S, Codullo, V, Cavagna, L, Bartoloni E., Gonzalez-Gay M. A., Scire CA., Castaneda S., Gerli R., Lopez-Longo F. J., Martinez-Barrio J., Govoni M., Furini F., Pina T., Iannone F., Giannini M., Nuno L., Quartuccio L., Ortego-Centeno N., Alunno A., Specker C., Montecucco C., Triantafyllias K., Balduzzi S., Sifuentes-Giraldo W. A., Paolazzi G., Bravi E., Schwarting A., Pellerito R., Russo A., Selmi C., Saketkoo L. -A., Fusaro E., Parisi S., Pipitone N., Franceschini F., Cavazzana I., Neri R., Barsotti S., Codullo V., Cavagna L., Bartoloni, E, Gonzalez-Gay, M, Scire, C, Castaneda, S, Gerli, R, Lopez-Longo, F, Martinez-Barrio, J, Govoni, M, Furini, F, Pina, T, Iannone, F, Giannini, M, Nuno, L, Quartuccio, L, Ortego-Centeno, N, Alunno, A, Specker, C, Montecucco, C, Triantafyllias, K, Balduzzi, S, Sifuentes-Giraldo, W, Paolazzi, G, Bravi, E, Schwarting, A, Pellerito, R, Russo, A, Selmi, C, Saketkoo, L, Fusaro, E, Parisi, S, Pipitone, N, Franceschini, F, Cavazzana, I, Neri, R, Barsotti, S, Codullo, V, Cavagna, L, Bartoloni E., Gonzalez-Gay M. A., Scire CA., Castaneda S., Gerli R., Lopez-Longo F. J., Martinez-Barrio J., Govoni M., Furini F., Pina T., Iannone F., Giannini M., Nuno L., Quartuccio L., Ortego-Centeno N., Alunno A., Specker C., Montecucco C., Triantafyllias K., Balduzzi S., Sifuentes-Giraldo W. A., Paolazzi G., Bravi E., Schwarting A., Pellerito R., Russo A., Selmi C., Saketkoo L. -A., Fusaro E., Parisi S., Pipitone N., Franceschini F., Cavazzana I., Neri R., Barsotti S., Codullo V., and Cavagna L.
- Abstract
Objective Arthritis, myositis and interstitial lung disease (ILD) constitute the classic clinical triad of anti-synthetase syndrome (ASSD). These patients experience other accompanying features, such as Raynaud's phenomenon, fever or mechanic's hands. Most ASSD patients develop the complete triad during the follow-up. In the present study we aimed to determine whether the subsequent appearance of accompanying features may suggest the development of triad findings lacking at the onset in anti-Jo1 positive ASSD patients. Methods Anti-Jo1 positive patients presenting with incomplete ASSD (no > 2 classic triad features) were assessed. Clinical characteristics and clusters of disease manifestations were retrospectively collected and analyzed in a large international multicenter cohort of ASSD patients. Results 165 patients (123 women) with incomplete ASSD were identified. Ninety-five patients (57.5%) developed new classic triad manifestations after 15 months median (IQR 9–51) and 40 (24%) developed new accompanying features after 19 months median (IQR 6–56) from disease onset. During the follow-up, the ex-novo occurrence of triad features was observed in 32 out of 40 patients (80%) with new accompanying findings and in 63 out of 125 patients (50.5%) without new accompanying findings (p = 0.002). In patients with at least one new accompanying feature the odds ratio for the occurrence of new triad manifestations was 3.94 with respect to patients not developing ex-novo accompanying findings (95% CI 1.68–9.21, p = 0.002). Conclusion Anti-Jo1 ASSD patients with incomplete forms at disease onset are at high risk for the subsequent occurrence of lacking classic triad findings. Although all ASSD patients should be carefully assessed for the occurrence of new triad features, a closer follow-up should be considered in the subgroup of patients developing ex novo accompanying findings. These patients, indeed, have near four-fold increased risk f
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- 2017
19. In early inflammatory polyarthritis more intensive management according to the 2010 ACR/EULAR criteria leads to higher rates of clinical remission: Comparison of two cohorts treated according to different treat to target protocols
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Balduzzi, S, Scire, C, Sakellariou, G, Benaglio, F, Bugatti, S, Montecucco, C, Caporali, R, Balduzzi S., Scire C. A., Sakellariou G., Benaglio F., Bugatti S., Montecucco C., Caporali R., Balduzzi, S, Scire, C, Sakellariou, G, Benaglio, F, Bugatti, S, Montecucco, C, Caporali, R, Balduzzi S., Scire C. A., Sakellariou G., Benaglio F., Bugatti S., Montecucco C., and Caporali R.
- Abstract
Objective The aim of this study was to compare the 12-month probability of remission in early inflammatory arthritis with a milder treatment based on the 1987 criteria or a more intensive protocol based on the 2010 criteria. Methods Patients with rheumatoid arthritis (RA) or undifferentiated arthritis (UA) (2005-2012) were included. Before October 2010, patients fulfilling the 1987 criteria received methotrexate (MTX) and possibly low-dose prednisone, while UA hydroxychloroquine (HCQ) (1987-driven cohort). From October 2010, patients fulfilling the 2010 criteria received higher dose MTX and low-dose prednisone, while UA HCQ (2010-driven cohort). Treatment was increased to achieve DAS28 low disease activity. Clinical remission, defined by DAS28, was evaluated at subsequent visits in the whole population. Hazard ratios (HR) adjusted for age, sex, baseline DAS28, symptoms duration, MTX dose and prednisone were calculated by Cox regression. Results 677 patients were included (468 in 1987-driven cohort, 209 in 2010-driven cohort), with no significant differences in age, gender, autoantibodies and pain. The 2010-driven cohort had significantly fewer tender and swollen joints, lower acute phase reactants, DAS28 and HAQ and achieved more frequently remission even when the analysis was adjusted for all confounders (adjusted HR (95% CI) 1.73 (1.34, 2.22)) and limited to per protocol patients (adjusted HR (95%CI) 1.49 (1.11, 2.02). Conclusion Treating patients with early arthritis according to a more intensive protocol leads to higher remission rate. The results of this study support the use of a strategy led by the 2010 criteria with more intensive treatment strategies in the management of early arthritis.
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- 2017
20. Clinical differences in sarcoidosis patients with and without lymphoma: A single-centre retrospective cohort analysis
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Cerri, S, Fontana, M, Balduzzi, S, Potenza, L, Faverio, P, Luppi, M, D'Amico, R, Spagnolo, P, Clini, E, Luppi, F, Cerri, Stefania, Fontana, Matteo, Balduzzi, Sara, Potenza, Leonardo, Faverio, Paola, Luppi, Mario, D'Amico, Roberto, Spagnolo, Paolo, Clini, Enrico, Luppi, Fabrizio, Cerri, S, Fontana, M, Balduzzi, S, Potenza, L, Faverio, P, Luppi, M, D'Amico, R, Spagnolo, P, Clini, E, Luppi, F, Cerri, Stefania, Fontana, Matteo, Balduzzi, Sara, Potenza, Leonardo, Faverio, Paola, Luppi, Mario, D'Amico, Roberto, Spagnolo, Paolo, Clini, Enrico, and Luppi, Fabrizio
- Published
- 2019
21. Validation of the American Joint Committee on Cancer new prognostic stage groups for HER2-positive breast cancer patients treated with adjuvant chemotherapy and trastuzumab in the prospective ShortHER trial
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Dieci, M.V., primary, Bisagni, G., additional, Brandes, A.A., additional, Frassoldati, A., additional, Donadio, M., additional, Garrone, O., additional, Piacentini, F., additional, Balduzzi, S., additional, Guarneri, V., additional, and Conte, P.F., additional
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- 2019
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22. Effectiveness of support groups to improve the quality of life of people with idiopathic pulmonary fibrosis a pre-post test pilot study
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Magnani, Daniela, Lenoci, D, G, Balduzzi, S, Artioli, G, and Ferri, Paola
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Male ,Self-Help Groups ,Original Article: New Tools for Health Professionals ,quality of life ,support groups ,Humans ,psychological well-being ,Female ,Pilot Projects ,Middle Aged ,idiopathic pulmonary fibrosis ,respiratory tract diseases ,Aged - Abstract
Background and aim of the work: Idiopathic Pulmonary Fibrosis (IPF) is an interstitial lung disease, which progressively leads to severe disability and death. The average survival expectancy, ranges from 3 to 5 years from diagnosis, and the available medicines do not lead to healing. The progression of IPF lead to a decline in forced vital capacity (FVC), dyspnea, cough, continuous sleep interruptions, resulting in increased fatigue and deteriorating quality of life (QOL), progressive limitation of daily life activities and social life, with repercussions on psychological and emotional well-being, aggravated by anxiety, loss of sense of self-confidence and depression. The aim of the study was to evaluate how the support groups influence the psychological well-being of people with IPF and their family members. Methods: A pre-post test pilot study with a single group was conducted in a university hospital in Northern Italy, a centre for diagnosis and treatment of IPF. A support group was conducted by a nurse and entirely dedicated to people with IPF and their family members. Eighteen participants were enrolled in the support group. To measure the changes in psychological well-being was chosen the Psychological General Well-Being Index (PGWBI), which was administered at the time of enrolment to the group and after six months of attendance. Results: Even if the effect is not statistically significant, the paired t-test showed that the participation in a support group conducted by a nurse, could increase psychological well-being in all of its dimensions: anxiety, depression, positivity, self-control, overall health, and vitality. Conclusions: Despite the null association, the increase of psychological well-being, closely related to the quality of life, indicates the need to further studies. In the absence of effective pharmacological treatments for healing, the support groups represent an opportunity for the wellbeing of the IPF patients and their caregivers.
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- 2017
23. 3* Final analysis of the phase III multicentric Italian study Short-HER: 9 weeks vs 1 year adjuvant trastuzumab for HER2+ early breast cancer
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Conte, P, Bisagni, G, Frassoldati, A, Brandes, A, Cavanna, L, Giotta, F, Aieta, M, Gebbia, V, Musolino, A, Garrone, O, Donadio, M, Cavazzini, G, Turletti, A, Zamagni, C, Danese, S, Ferro, A, Piacentini, F, Balduzzi, S, D'Amico, R, and Guarneri, V
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trastuzumab ,breast cancer ,immunologic adjuvants ,pharmaceutical adjuvants ,trastuzumab, immunologic adjuvants, pharmaceutical adjuvants, breast cancer - Published
- 2017
24. 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: Subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio
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Conte, P.F., primary, Guarneri, V., additional, Bisagni, G., additional, Piacentini, F., additional, Brandes, A.A., additional, Cavanna, L., additional, Giotta, F., additional, Aieta, M., additional, Gebbia, V., additional, Frassoldati, A., additional, Musolino, A., additional, Garrone, O., additional, Taverniti, C., additional, Rimanti, A., additional, Sarti, S., additional, Rubino, D., additional, Bologna, A., additional, Vicini, R., additional, Balduzzi, S., additional, and D'Amico, R., additional
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- 2018
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25. Abstract P1-13-02: Withdrawn
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Guarneri, V, primary, Dieci, MV, additional, Bisagni, G, additional, Brandes, AA, additional, Frassoldati, A, additional, Cavanna, L, additional, Musolino, A, additional, Giotta, F, additional, Cavazzini, G, additional, Garrone, O, additional, Bertone, E, additional, Cagossi, K, additional, Nanni, O, additional, Ferro, A, additional, Donadio, M, additional, Aieta, M, additional, Zamagni, C, additional, Piacentini, F, additional, Maiorana, A, additional, Ragazzi, M, additional, Cucchi, MC, additional, Querzoli, P, additional, Orsi, N, additional, Curtarello, M, additional, Urso, L, additional, Amadori, A, additional, Orvieto, E, additional, Vicini, R, additional, Balduzzi, S, additional, D'Amico, R, additional, and Conte, P, additional
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- 2018
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26. Estimate of false-positive breast cancer diagnoses from accuracy studies: A systematic review
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Segnan, N, Minozzi, S, Ponti, A, Bellisario, C, Balduzzi, S, González-Lorenzo, M, Gianola, S, Armaroli, P, Segnan, N, Minozzi, S, Ponti, A, Bellisario, C, Balduzzi, S, González-Lorenzo, M, Gianola, S, and Armaroli, P
- Abstract
Background False-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast. Methods PubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. Outcomes: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool. Results Sixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%-7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%-2.4% (K values 0.83-0.98); at surgical excision, it was 0.67%-1.2% (K values 0.86-0.94). Studies with enriched samples: the MBM range was 1.4%-6.2% (K values 0.57-0.86). Studies of cases selected for second opinion: the MBM range was 0.29%-12.2% (K values 0.48 and 0.50). Conclusions High heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.
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- 2017
27. TIPIZZAZIONE CLINICA DELLA SINDROME ANTISINTETASICA: CONFRONTO TRA PAZIENTI ANTI JO-1 POSITIVI E NEGATIVI
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Codullo, V., Gonzalez Gay, M. A., Neri, R., Barsotti, S., Franceschini, F., Cavazzana, I., Montecucco, C., Caporali, R., Balduzzi, S., Selmi, C. F., Pesci, A., Dei, G., Meloni, F., Batticciotto, A., Emmi, G., Benucci, M., Cimmino, M. A., Doria, A., Ghirardello, A., Quartuccio, L., Paolazzi, G., Pipitone, N., Salaffi, F., Sebastiani, Marco, Manfredi, Andreina Teresa, Govoni, M., Furini, F., Parisi, S., Pellerito, R., Iannone, F., Giannini, M., Bartoloni Bocci, E., Conti, F., Bravi, E., Iuliano, A., Tomietto, P., Scirè, C. A., Castaneda, S., Cosso, C., Selva O’Callaghan, A., Confalonieri, M., and Cavagna, L.
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sindrome antisintetasica - Published
- 2016
28. Final analysis of the phase III multicentric Italian study Short-HER: 9 weeks vs 1 year adjuvant trastuzumab for HER2+ early breast cancer
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Conte, P., primary, Conte, P., additional, Bisagni, G., additional, Frassoldati, A., additional, Brandes, A., additional, Cavanna, L., additional, Giotta, F., additional, Aieta, M., additional, Gebbia, V., additional, Musolino, A., additional, Garrone, O., additional, Donadio, M., additional, Cavazzini, G., additional, Turletti, A., additional, Zamagni, C., additional, Danese, S., additional, Ferro, A., additional, Piacentini, F., additional, Balduzzi, S., additional, D'Amico, R., additional, and Guarneri, V., additional
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- 2017
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29. Antibiotic treatment of severe exacerbations of chronic obstructive pulmonary disease with procalcitonin: a randomized noninferiority trial
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Verduri, A, Luppi, F, D'Amico, R, Balduzzi, S, Vicini, R, Liverani, A, Ruggieri, V, Plebani, M, Barbaro, Mp, Spanevello, A, Canonica, Gw, Papi, A, Fabbri, Lm, Beghè, B, FARM58J2XH Study Group: Fabbri LM, Beghé, B, Franco, F, De Carlo MR, Confalonieri, M, Milani, G, Pozzi, E, Luisetti, M, Cerveri, I, Niniano, R, Marsico, S, Calabrese, C, Olivieri, D, Tzani, P, Torre, O, Braido, F, Salerno, F, Carone, M, Zucchi, L, Menzella, F, Castagnetti, C, Paggiaro, Pl, Vagaggini, B, Costa, F, Contoli, M, Marku, B, Cagnazzo, Mg, Crimi, Nunzio, Mastruzzo, C, Ciccarelli, M, Calabro, S, Balestro, E, Rossi, A, Donazzan, G, Bonazza, L, Zuin, R, Pistolesi, M, and Bigazzi, F.
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Sepsis ,C-Reactive Protein ,Serum procalcitonin - Published
- 2015
30. Non-steroid agents for idiopathic pulmonary fibrosis
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Spagnolo, P, Del Giovane, C, Luppi, F, Cerri, S, Balduzzi, S, Walters, E, D'Amico, R, Richeldi, L, Spagnolo P, Del Giovane C, Luppi F, Cerri S, Balduzzi S, Walters EH, D'Amico R, Richeldi L, Spagnolo, P, Del Giovane, C, Luppi, F, Cerri, S, Balduzzi, S, Walters, E, D'Amico, R, Richeldi, L, Spagnolo P, Del Giovane C, Luppi F, Cerri S, Balduzzi S, Walters EH, D'Amico R, and Richeldi L
- Abstract
BACKGROUND: Idiopathic pulmonary fibrosis is a chronic progressive lung disease with poor outcome and no effective treatment to date. This is an update of a Cochrane Review first published in 2003. OBJECTIVES: To assess the efficacy of non-steroid agents in adults with idiopathic pulmonary fibrosis. SEARCH STRATEGY: We searched the Cochrane Airways Group Register (30 March 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2010), Ovid MEDLINE to March week 5, 2010, EMBASE to week 13, 2010 and PubMed to April 2010, with additional handsearching, including abstracts of international conferences. We also contacted pharmaceutical companies and researchers in the field. SELECTION CRITERIA: Randomised studies comparing non-steroid drugs with placebo or steroids in adults with idiopathic pulmonary fibrosis. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality, extracted data and assessed risk of bias. We contacted pharmaceutical companies to obtain missing information, if any. We combined survival outcomes using Peto odds ratios or hazard ratios (HR). MAIN RESULTS: Fifteen trials involving 10 different drugs were included. Two trials enrolling 1156 patients compared interferon gamma-1beta with placebo: interferon gamma-1beta did not significantly improve survival (HR 0.88, 95% CI 0.47 to 1.64; P = 0.68). Four trials involving 1155 patients compared pirfenidone with placebo. Three trials, conducted in 1046 patients, provided data on progression-free survival: pirfenidone significantly reduced the risk of disease progression by 30% (HR 0.70, 95% CI 0.56 to 0.88, P = 0.002). Data on the effect of pirfenidone on pulmonary function could only be assessed for two studies analysing 314 patients. Forced vital capacity or vital capacity was significantly improved by pirfenidone (mean difference 0.08 L, 95% CI 0.03 to 0.13, P = 0.0006). AUTHORS' CONCLUSIONS: Based on available data, partly still unpublished
- Published
- 2010
31. PET/CT with (11)C-choline for evaluation of prostate cancer patients with biochemical recurrence: meta-analysis and critical review of available data
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Fanti, S., Minozzi, S., Castellucci, P., Balduzzi, S., Herrmann, K., Krause, B.J., Oyen, W.J.G., Chiti, A., Fanti, S., Minozzi, S., Castellucci, P., Balduzzi, S., Herrmann, K., Krause, B.J., Oyen, W.J.G., and Chiti, A.
- Abstract
Item does not contain fulltext, PURPOSE: For the last decade PET and PET/CT with (11)C-choline have been proposed for the evaluation of prostate cancer (PC), but the diagnostic performance of (11)C-choline PET/CT is still a matter of debate. We performed a comprehensive review of the most important clinical application of (11)C-choline PET, restaging of patients with biochemical relapse, following a rigorous methodological approach and including assessment of the risk of bias. We conducted a systematic review and meta-analysis of the literature assessing (11)C-choline PET/CT for its accuracy in the diagnosis and ability to detect the site of recurrence of PC in the restaging of patients with biochemical recurrence after initial treatment with curative intent. METHODS: We performed a comprehensive literature search of PubMed and the Cochrane Library to determine the accuracy for the detection of the site of recurrence (prostate bed recurrences, metastatic spread to locoregional pelvic lymph nodes or distant metastases). Only studies with a reference standard (for prostatic bed histopathology, for histopathology or biopsy of distant metastases or a composite reference standard with clinical follow-up of at least 12 months, correlative imaging and clinical data) were included. RESULTS: Overall 425 studies were retrieved, of which 43 were judged as potentially relevant and 29 with 2,686 participants were finally included. Of these 29 studies, 18 reported results for any relapse, All 18 studies, with a total of 2,126 participants, reported detection rates. The pooled rate was 62 % (95 % CI 53 - 71 %). Of the 18 studies, 12 with 1,270 participants reported useful data to derive sensitivity and specificity. The pooled sensitivity was 89 % (95 % CI 83 - 93 %) and the pooled specificity was 89 % (95 % CI 73 - 96 %). Of 11 studies reporting results for local relapse, 9 with 993 participants reported detection rates. The pooled rate was 27 % (95 % CI 16 - 38 %). Six studies with 491 participants reported sen
- Published
- 2016
32. Safety and efficacy of T-DM1 in HER2 positive metastatic breast cancer patients: a real word experience
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Omarini, C., primary, Medici, G., additional, Guaitoli, G., additional, Iattoni, E., additional, Moscetti, L., additional, Balduzzi, S., additional, Cascinu, S., additional, and Piacentini, F., additional
- Published
- 2016
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33. 191PD_PR - 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: Subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio
- Author
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Conte, P.F., Guarneri, V., Bisagni, G., Piacentini, F., Brandes, A.A., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Frassoldati, A., Musolino, A., Garrone, O., Taverniti, C., Rimanti, A., Sarti, S., Rubino, D., Bologna, A., Vicini, R., Balduzzi, S., and D'Amico, R.
- Published
- 2018
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34. HRCT Patterns Of Usual Interstitial Pneumonia In Rheumatoid Lung
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Tonelli, R, Sverzellati, N, DELLA CASA, G, Spagnolo, P, Cerri, S, Manfredi, A, Sebastiani, M, Cocconcelli, E, DEL GIOVANE, C, Balduzzi, S, Richeldi, L, Torricelli, P, Ferri, C, Luppi, F, TONELLI, ROBERTO, Sverzellati, Nicola, DELLA CASA, GIOVANNI, SPAGNOLO, Paolo, CERRI, Stefania, MANFREDI, Andreina Teresa, SEBASTIANI, Marco, COCCONCELLI, ELISABETTA, DEL GIOVANE, Cinzia, BALDUZZI, Sara, RICHELDI, Luca, TORRICELLI, Pietro, FERRI, Clodoveo, LUPPI, Fabrizio, Tonelli, R, Sverzellati, N, DELLA CASA, G, Spagnolo, P, Cerri, S, Manfredi, A, Sebastiani, M, Cocconcelli, E, DEL GIOVANE, C, Balduzzi, S, Richeldi, L, Torricelli, P, Ferri, C, Luppi, F, TONELLI, ROBERTO, Sverzellati, Nicola, DELLA CASA, GIOVANNI, SPAGNOLO, Paolo, CERRI, Stefania, MANFREDI, Andreina Teresa, SEBASTIANI, Marco, COCCONCELLI, ELISABETTA, DEL GIOVANE, Cinzia, BALDUZZI, Sara, RICHELDI, Luca, TORRICELLI, Pietro, FERRI, Clodoveo, and LUPPI, Fabrizio
- Abstract
RATIONALE. Interstitial lung disease (ILD) is a well-recognized complication of rheumatoid arthritis (RA) and can present with different patterns on high-resolution computed tomography (HRCT) of the chest. It has been recently shown that a definite HRCT usual interstitial pneumonia (UIP) pattern is highly specific and moderately sensitive for a histopathologic UIP pattern. The aims of the present study were: i) to evaluate the prevalence of the UIP pattern on HRCT in patients with RA-ILD, as compared with patients with idiopathic pulmonary fibrosis (IPF) and ii) to assess the level of agreement between two experienced chest radiologists in detecting the UIP pattern in the two groups of patients. METHODS. 30 patients with RA and at least one chest HRCT showing interstitial changes were retrospectively identified from a single-center cohort of RA patients. Fifty-two patients with IPF based on current diagnostic criteria served as diseased controls. For patients who had more than one HRCT the more recent HRCT was selected. Two experienced thoracic radiologists (radiologist A and B) blinded to patient diagnosis scored all HRCT images independently. Radiologic patterns were categorized as definite UIP, possible UIP or inconsistent with UIP according to the most current international guidelines. The prevalence of the different patterns was assessed for both groups and compared by using the chi square test. The concordance between radiologists was determined using the Cohen kappa score. RESULTS. Radiologist A detected 4 definite UIP (13%), 10 possible UIP (33%) and 16 inconsistent with UIP patterns (53%) among patients with RA-ILD and 16 definite UIP (30%), 24 possible UIP (46%) and 12 inconsistent with UIP patterns (23%) among patients with IPF (chi square 0.016). Radiologist B identified 6 definite UIP (20%), 9 possible UIP (30%) and 15 inconsistent with UIP patterns (50%) in the RA-ILD group and 23 definite UIP (44%), 16 possible UIP (30%) and 13 inconsistent with UIP p
- Published
- 2014
35. Prevalence Of Subclinical Liver Fibrosis Among Patients With Idiopathic Pulmonary Fibrosis
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Cocconcelli, E, Cerri, S, Spagnolo, P, Tonelli, R, Ventura, P, Abbati, G, Vegetti, A, Pileri, F, DEL GIOVANE, C, Balduzzi, S, Pietrangelo, A, Richeldi, L, Luppi, F, COCCONCELLI, ELISABETTA, CERRI, Stefania, SPAGNOLO, Paolo, TONELLI, ROBERTO, VENTURA, Paolo, Abbati, Gianluca, VEGETTI, Alberto, PILERI, Francesca, DEL GIOVANE, Cinzia, BALDUZZI, Sara, PIETRANGELO, Antonello, RICHELDI, Luca, LUPPI, Fabrizio, Cocconcelli, E, Cerri, S, Spagnolo, P, Tonelli, R, Ventura, P, Abbati, G, Vegetti, A, Pileri, F, DEL GIOVANE, C, Balduzzi, S, Pietrangelo, A, Richeldi, L, Luppi, F, COCCONCELLI, ELISABETTA, CERRI, Stefania, SPAGNOLO, Paolo, TONELLI, ROBERTO, VENTURA, Paolo, Abbati, Gianluca, VEGETTI, Alberto, PILERI, Francesca, DEL GIOVANE, Cinzia, BALDUZZI, Sara, PIETRANGELO, Antonello, RICHELDI, Luca, and LUPPI, Fabrizio
- Abstract
Rationale Idiopathic pulmonary fibrosis (IPF) is a specific form of progressive fibrosing interstitial pneumonia of unknown cause. Common pathogenic mechanisms with chronic fibrotic disorders involving other organs are likely. Yet, data on the co-existence of subclinical fibrotic disease across multiple organs in patients with IPF are lacking. The present study aimed to investigate the prevalence of subclinical liver fibrosis among patients with IPF. Methods Patients referred to the Center for Rare Lung Disease of the University Hospital of Modena, with a diagnosis of IPF according to recent guidelines and without previous history of liver diseases underwent hepatic transient elastography (FibroScan®), a non-invasive technique measuring liver stiffness, which routinely used for the assessment of hepatic fibrosis in patients with chronic liver diseases. Hepatic fibrotic status is expressed in a scale from 0 (absence of hepatic fibrosis) to 4 (severe liver fibrosis / cirrhosis). Patients with body mass index (BMI) ≥29 (confidence limit of the instrument) were excluded. Patients, in which any degree of hepatic fibrosis was detected, underwent screening for possible secondary causes of liver fibrosis. Results Among 48 IPF patients (34 males, mean age 69 years), 11 (23%) were excluded because of high BMI. In 8 out 37 patients (22%) it was not possible to obtain successful measurements due to the excess of subcutaneous adipose tissue in the chest wall, or narrow intercostal spaces. Thirteen of 37 patients (35%) had abnormal hepatic transient elastography results: 4 patients fell within the range F1-F2 (6.1-7.6 kPa), 6 in F2 (7.4-8.4 kPa), one in F2-F3 (9.5 kPa), 1 in F4 (14.3 kPa) and 1 was identified as probable fibrosis not otherwise classifiable. In all cases, secondary causes of hepatic fibrosis were excluded. Minor impairment of markers of liver injury was found in a minority of patients with liver fibrosis, with AST and ALT values exceeding the threshold value respe
- Published
- 2014
36. 3* - Final analysis of the phase III multicentric Italian study Short-HER: 9 weeks vs 1 year adjuvant trastuzumab for HER2+ early breast cancer
- Author
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Conte, P., Bisagni, G., Frassoldati, A., Brandes, A., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Musolino, A., Garrone, O., Donadio, M., Cavazzini, G., Turletti, A., Zamagni, C., Danese, S., Ferro, A., Piacentini, F., Balduzzi, S., D'Amico, R., and Guarneri, V.
- Published
- 2017
- Full Text
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37. F55 - Safety and efficacy of T-DM1 in HER2 positive metastatic breast cancer patients: a real word experience
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Omarini, C., Medici, G., Guaitoli, G., Iattoni, E., Moscetti, L., Balduzzi, S., Cascinu, S., and Piacentini, F.
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- 2016
- Full Text
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38. Alveolar haemorrhage in ANCA-associated vasculitis: Long-term outcome and mortality predictors
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Francesco Cianci, Francesco Ferro, Viviana Ravagnani, Sara Monti, Angela Padula, Silvia Balduzzi, Alvise Berti, Roberto Caporali, Paolo Stobbione, Marcello Govoni, Silvano Bettio, I. Leccese, M. C. Ditto, Stefano Murgia, Marco Matucci Cerinic, Lorenzo Dagna, Franco Schiavon, Federica Furini, Alessandra Bortoluzzi, Michele Colaci, Silvia Bellando Randone, Bernd Raffeiner, P.P. Sainaghi, Gian Luca Erre, Francesco Carubbi, Dario Roccatello, Milena Bond, Giulia Pazzola, Giuseppe Paolazzi, Mara Felicetti, Carlo Salvarani, Giuseppina Alfieri, Aurora Ianniello, Elena Silvestri, Roberto Padoan, Alessandro Giollo, Luca Quartuccio, Roberto Bortolotti, Claudia Lomater, Simone Parisi, Adriana Cariddi, Enrica Bozzolo, Salvatore D'Angelo, Giacomo Emmi, Salvatore De Vita, Gerardo Di Scala, Miriam Isola, Pietro Leccese, Elisa Gremese, Nicoletta Franzolini, Fabrizio Conti, Paola Faggioli, Quartuccio, L., Bond, M., Isola, M., Monti, S., Felicetti, M., Furini, F., Murgia, S., Berti, A., Silvestri, E., Pazzola, G., Bozzolo, E., Leccese, P., Raffeiner, B., Parisi, S., Leccese, I., Cianci, F., Bettio, S., Sainaghi, P., Ianniello, A., Ravagnani, V., Bellando Randone, S., Faggioli, P., Lomater, C., Stobbione, P., Ferro, F., Colaci, M., Alfieri, G., Carubbi, F., Erre, G. L., Giollo, A., Franzolini, N., Ditto, M. C., Balduzzi, S., Padoan, R., Bortolotti, R., Bortoluzzi, A., Cariddi, A., Padula, A., Di Scala, G., Gremese, E., Conti, F., D'Angelo, S., Matucci Cerinic, M., Dagna, L., Emmi, G., Salvarani, C., Paolazzi, G., Roccatello, D., Govoni, M., Schiavon, F., Caporali, R., and De Vita, S.
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0301 basic medicine ,Vasculitis ,Adult ,Male ,medicine.medical_specialty ,Immunology ,Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis ,Hemorrhage ,NO ,Alveolar haemorrhage ,Mortality ,Outcome ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Immunology and Allergy ,Medicine ,Humans ,Public Health Surveillance ,Cause of death ,Aged ,Retrospective Studies ,030203 arthritis & rheumatology ,Performance status ,business.industry ,Hazard ratio ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Prognosis ,Confidence interval ,Pulmonary Alveoli ,030104 developmental biology ,Respiratory failure ,Italy ,Female ,business ,Cohort study - Abstract
Introduction Alveolar haemorrhage (AH) is considered an important cause of morbidity and early mortality in anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides (AAV). Objectives The aim of this study was to identify predictors of outcome in patients with AH-AAV and to evaluate outcome and causes of death in this subset. Materials and methods A multicenter retrospective study was conducted in 29 Italian Centers. Clinicians were asked to recruit all patients diagnosed with AAV-associated AH during the last 10 years, from 2007 to 2016. Univariate and multivariable analysis were performed. Results One-hundred and six patients were included (median age at onset of 55 years [IQR 42–67]). The majority were ANCA-positive (PR3 57.1%, MPO 33.7%) and 72.6% had also renal involvement. At presentation, anaemia was shown in 97 (92.4%) patients, hemoptysis in 54 (51.9%), respiratory failure in 68 (66.7%), of whom 48 (70.6%), requiring respiratory support. At the end of the 37 months [IQR 13–77] follow-up, 19/106 (17.9%) patients were dead. The main causes of death were active disease and infections. By stepwise regression analysis, age >65 years (HR 3.66 [95% CI 1.4–9.51], p = 0.008) and the need for respiratory support (HR 4.58 [95% CI 1.51–13.87], p = 0.007) at AH onset were confirmed to be predictive of mortality. Conclusions Predictors of outcome in AAV-AH were determined. Factors related to the patient's performance status and the severity of the lung involvement strongly influenced the outcome. Balancing harms and benefits for the individual patient in induction and maintenance treatment strategies is crucial.
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- 2020
39. Clinical follow-up predictors of disease pattern change in anti-Jo1 positive anti-synthetase syndrome: Results from a multicenter, international and retrospective study
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Walter Alberto Sifuentes-Giraldo, Simone Parisi, Carlomaurizio Montecucco, Norberto Ortego-Centeno, Alessandra Russo, Marcello Govoni, Andreas Schwarting, Carlo Alberto Scirè, L.A. Saketkoo, Francisco Javier López-Longo, Raffaele Pellerito, Alessia Alunno, Santos Castañeda, Miguel A. González-Gay, Rossella Neri, Nicolò Pipitone, Veronica Codullo, Lorenzo Cavagna, Trinitario Pina, Franco Franceschini, E. Bravi, Simone Barsotti, Giuseppe Paolazzi, Roberto Gerli, Florenzo Iannone, Carlo Selmi, Silvia Balduzzi, Konstantinos Triantafyllias, Federica Furini, Elena Bartoloni, Margherita Giannini, Julia Martínez-Barrio, Laura Nuño, Enrico Fusaro, Luca Quartuccio, Christopher Specker, Ilaria Cavazzana, Bartoloni, E, Gonzalez-Gay, M, Scire, C, Castaneda, S, Gerli, R, Lopez-Longo, F, Martinez-Barrio, J, Govoni, M, Furini, F, Pina, T, Iannone, F, Giannini, M, Nuno, L, Quartuccio, L, Ortego-Centeno, N, Alunno, A, Specker, C, Montecucco, C, Triantafyllias, K, Balduzzi, S, Sifuentes-Giraldo, W, Paolazzi, G, Bravi, E, Schwarting, A, Pellerito, R, Russo, A, Selmi, C, Saketkoo, L, Fusaro, E, Parisi, S, Pipitone, N, Franceschini, F, Cavazzana, I, Neri, R, Barsotti, S, Codullo, V, and Cavagna, L
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Male ,medicine.medical_specialty ,Prognosi ,Immunology ,Medizin ,Arthritis ,Interstitial lung disease ,Disease ,NO ,Ligases ,03 medical and health sciences ,0302 clinical medicine ,Anti-synthetase syndrome ,mechanic's hand ,Myositis ,Prognosis ,Raynaud's phenomenon ,Autoantibodies ,Female ,Follow-Up Studies ,Humans ,Middle Aged ,Raynaud Disease ,Retrospective Studies ,Syndrome ,Immunology and Allergy ,Internal medicine ,Medicine ,030212 general & internal medicine ,Myositi ,030203 arthritis & rheumatology ,business.industry ,Autoantibody ,Retrospective cohort study ,Odds ratio ,medicine.disease ,Surgery ,Cohort ,business - Abstract
Objective Arthritis, myositis and interstitial lung disease (ILD) constitute the classic clinical triad of anti-synthetase syndrome (ASSD). These patients experience other accompanying features, such as Raynaud's phenomenon, fever or mechanic's hands. Most ASSD patients develop the complete triad during the follow-up. In the present study we aimed to determine whether the subsequent appearance of accompanying features may suggest the development of triad findings lacking at the onset in anti-Jo1 positive ASSD patients. Methods Anti-Jo1 positive patients presenting with incomplete ASSD (no >2 classic triad features) were assessed. Clinical characteristics and clusters of disease manifestations were retrospectively collected and analyzed in a large international multicenter cohort of ASSD patients. Results 165 patients (123 women) with incomplete ASSD were identified. Ninety-five patients (57.5%) developed new classic triad manifestations after 15months median (IQR 9–51) and 40 (24%) developed new accompanying features after 19months median (IQR 6–56) from disease onset. During the follow-up, the ex-novo occurrence of triad features was observed in 32 out of 40 patients (80%) with new accompanying findings and in 63 out of 125 patients (50.5%) without new accompanying findings (p=0.002). In patients with at least one new accompanying feature the odds ratio for the occurrence of new triad manifestations was 3.94 with respect to patients not developing ex-novo accompanying findings (95% CI 1.68–9.21, p=0.002). Conclusion Anti-Jo1 ASSD patients with incomplete forms at disease onset are at high risk for the subsequent occurrence of lacking classic triad findings. Although all ASSD patients should be carefully assessed for the occurrence of new triad features, a closer follow-up should be considered in the subgroup of patients developing ex novo accompanying findings. These patients, indeed, have near four-fold increased risk for new classic triad manifestation occurrence with respect to patients not presenting ex novo accompanying findings.
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- 2017
40. Estimate of false-positive breast cancer diagnoses from accuracy studies: a systematic review
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Cristina Bellisario, Sara Balduzzi, Silvia Minozzi, Antonio Ponti, Silvia Gianola, Nereo Segnan, Paola Armaroli, Marien González-Lorenzo, Segnan, N, Minozzi, S, Ponti, A, Bellisario, C, Balduzzi, S, González-Lorenzo, M, Gianola, S, and Armaroli, P
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medicine.medical_specialty ,Breast Neoplasms ,Cochrane Library ,DIAGNOSIS ,Pathology and Forensic Medicine ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,BREAST CANCER ,Epidemiology ,medicine ,Humans ,EPIDEMIOLOGY ,False Positive Reactions ,030212 general & internal medicine ,Medical diagnosis ,Overdiagnosis ,Reproducibility ,business.industry ,Second opinion ,False Positive Reaction ,General Medicine ,medicine.disease ,Surgery ,Sample size determination ,030220 oncology & carcinogenesis ,Female ,Radiology ,business ,Breast Neoplasm ,Human - Abstract
BackgroundFalse-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast.MethodsPubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. Outcomes: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool.ResultsSixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%–7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%–2.4% (K values 0.83–0.98); at surgical excision, it was 0.67%–1.2% (K values 0.86–0.94). Studies with enriched samples: the MBM range was 1.4%–6.2% (K values 0.57–0.86). Studies of cases selected for second opinion: the MBM range was 0.29%–12.2% (K values 0.48 and 0.50).ConclusionsHigh heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.
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- 2017
41. Predictive Role Of Body Composition Parameters In Operable Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
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Omarini,Claudia, Palumbo,Patrizia, Pecchi,Annarita, Draisci,Stefano, Balduzzi,Sara, Nasso,Cecilia, Barbolini,Monica, Isca,Chrystel, Bocconi,Alessandro, Moscetti,Luca, Galetti,Silvia, Tazzioli,Giovanni, Torricelli,Pietro, Cascinu,Stefano, Piacentini,Federico, Omarini, C., Palumbo, P., Pecchi, A., Draisci, S., Balduzzi, S., Nasso, C., Barbolini, M., Isca, C., Bocconi, A., Moscetti, L., Galetti, S., Tazzioli, G., Torricelli, P., Cascinu, S., and Piacentini, F.
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Sarcopenia ,Pathological complete response ,Fat tissue ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,lcsh:RC254-282 ,sarcopenia ,BMI ,breast cancer ,Breast cancer ,Cancer Management and Research ,pathological complete response ,fat tissue ,BMI, fat tissue, sarcopenia, pathological complete response, breast cancer ,Original Research - Abstract
Claudia Omarini,1 Patrizia Palumbo,2 Annarita Pecchi,3 Stefano Draisci,3 Sara Balduzzi,4 Cecilia Nasso,1 Monica Barbolini,1 Chrystel Isca,1 Alessandro Bocconi,1 Luca Moscetti,1 Silvia Galetti,5 Giovanni Tazzioli,6 Pietro Torricelli,3 Stefano Cascinu,1 Federico Piacentini1 1Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 2Division of Clinical Nutrition and Metabolism, Department of Specialist Medicines, University Hospital of Modena, Modena, Italy; 3Department of Radiology, University Hospital of Modena, Modena, Italy; 4Statistics Unit, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 5Division of Clinical Nutrition and Metabolism, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 6Department of General Surgery and Surgical Specialities, University Hospital of Modena, Modena, ItalyCorrespondence: Claudia OmariniDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Via Del Pozzo 71, Modena 41122, ItalyTel +39 059 4222845Email claudia.omarini@gmail.comBackground: Fat tissue is strongly involved in BC tumorigenesis inducing insulin resistance, chronic inflammation and hormonal changes. Computed tomography (CT) imaging instead of body mass index (BMI) gives a reliable measure of skeletal muscle mass and body fat distribution. The impact of body composition parameters (BCPs) on chemosensitivity is still debated. We examined the associations between BCPs and tumor response to neoadjuvant chemotherapy (NC) in patients treated for operable breast cancer (BC).Methods: A retrospective review of BC patients treated with NC in Modena Cancer Center between 2005 and 2017 was performed. BCPs, such as subcutaneous fat area (SFA), visceral fat area (VFA), lumbar skeletal muscle index (LSMI) and liver-to-spleen (L/S) ratio were calculated by Advance workstation (General Electric), software ADW server 3.2 or 4.7. BMI and BCPs were correlated with pathological complete response (pCR) and survival outcomes.Results: 407 patients were included in the study: 55% with BMI < 25 and 45% with BMI ≥ 25. 137 of them had pre-treatment CT scan imagines. Overweight was significantly associated with postmenopausal status and older age. Hormonal receptor positive BC was more frequent in overweight patients (p
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- 2019
42. Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial
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Gaia Griguolo, Maria Vittoria Dieci, Roberto D'Amico, Samanta Sarti, R. Vicini, Luigi Cavanna, Claudio Zamagni, Anita Rimanti, Ornella Garrone, Alessandra Beano, S. Danese, Antonio Frassoldati, Alba A. Brandes, Francesco Giotta, Viviana Bazan, Michele Aieta, Katia Cagossi, Maria Pia Foschini, L. Amaducci, Antonella Ferro, Federico Piacentini, Sante Romito, Michela Donadio, Vittorio Gebbia, Valentina Guarneri, Pierfranco Conte, Anna Rita Gambaro, Sara Balduzzi, G. Moretti, Giancarlo Bisagni, Hector Soto Parra, Antonino Musolino, Dieci M.V., Bisagni G., Brandes A.A., Frassoldati A., Cavanna L., Giotta F., Aieta M., Gebbia V., Musolino A., Garrone O., Donadio M., Rimanti A., Beano A., Zamagni C., Soto Parra H., Piacentini F., Danese S., Ferro A., Cagossi K., Sarti S., Gambaro A.R., Romito S., Bazan V., Amaducci L., Moretti G., Foschini M.P., Balduzzi S., Vicini R., D'Amico R., Griguolo G., Guarneri V., and Conte P.F.
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Oncology ,Settore MED/06 - Oncologia Medica ,medicine.medical_treatment ,lcsh:Medicine ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,Breast cancer ,Trastuzumab ,Antineoplastic Combined Chemotherapy Protocols ,8th AJCC ,030212 general & internal medicine ,Stage (cooking) ,HER2-positive ,Prognostic stage ,General Medicine ,Middle Aged ,Prognosis ,Immunological ,Local ,030220 oncology & carcinogenesis ,Female ,Research Article ,medicine.drug ,Adult ,medicine.medical_specialty ,Randomization ,Socio-culturale ,Antineoplastic Agents ,Breast Neoplasms ,Disease-Free Survival ,03 medical and health sciences ,Internal medicine ,medicine ,Adjuvant therapy ,Humans ,erbB-2 ,Aged ,Neoplasm Staging ,Cancer staging ,Chemotherapy ,business.industry ,lcsh:R ,Cancer ,Genes, erbB-2 ,medicine.disease ,HER2-positive, Breast cancer, Trastuzumab, Prognostic stage, 8th AJCC ,Neoplasm Recurrence ,Genes ,Neoplasm Recurrence, Local ,business - Abstract
Background The 8th edition of the American Joint Committee on Cancer (AJCC) staging has introduced prognostic stage based on anatomic stage combined with biologic factors. We aimed to validate the prognostic stage in HER2-positive breast cancer patients enrolled in the ShortHER trial. Methods The ShortHER trial randomized 1253 HER2-positive patients to 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Patients were classified according to the anatomic and the prognostic stage. Distant disease-free survival (DDFS) was calculated from randomization to distant relapse or death. Results A total of 1244 patients were included. Compared to anatomic stage, the prognostic stage downstaged 41.6% (n = 517) of patients to a more favorable stage category. Five-year DDFS based on anatomic stage was as follows: IA 96.6%, IB 94.1%, IIA 92.4%, IIB 87.3%, IIIA 81.3%, IIIC 70.5% (P P P = 0.975). Within anatomic stage I, the outcome was similar for patients treated with 9 weeks or 1 year trastuzumab (5-year DDFS 96.2% and 96.6%, P = 0.856). Within prognostic stage I, the outcome was numerically worse for patients treated with 9 weeks trastuzumab (5-year DDFS 93.7% and 96.3%, P = 0.080). Conclusions The prognostic stage downstaged 41.6% of patients, while maintaining a similar prognostic performance as the anatomic stage. The prognostic stage is valuable in counseling patients and may serve as reference for a clinical trial design. Our data do not support prognostic stage as guidance to de-escalate treatment. Trial registration EUDRACT number: 2007-004326-25; NCI ClinicalTrials.gov number: NCT00629278.
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- 2019
43. Clinical differences in sarcoidosis patients with and without lymphoma: a single-center retrospective cohort analysis
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Stefania Cerri, Matteo Fontana, Leonardo Potenza, Fabrizio Luppi, Paola Faverio, Sara Balduzzi, Paolo Spagnolo, Enrico Clini, Roberto D'Amico, Mario Luppi, Cerri, S, Fontana, M, Balduzzi, S, Potenza, L, Faverio, P, Luppi, M, D'Amico, R, Spagnolo, P, Clini, E, and Luppi, F
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,Retrospective cohort study ,medicine.disease ,Lung involvement ,Lymphoma ,03 medical and health sciences ,Single centre ,0302 clinical medicine ,030228 respiratory system ,Internal medicine ,Pulmonary fibrosis ,medicine ,Restrictive ventilatory defect ,In patient ,030212 general & internal medicine ,Sarcoidosis ,business ,sarcoidosis, pulmonary fibrosis, biomarkers - Abstract
Patients with sarcoidosis showed a more frequent lung involvement and a restrictive ventilatory defect. Serum ACE was markedly higher in patients with sarcoidosis–lymphoma syndrome, indicating that those patients should be monitored over longer periods.http://bit.ly/327WBUM
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- 2019
44. 88O Validation of the American Joint Committee on Cancer new prognostic stage groups for HER2-positive breast cancer patients treated with adjuvant chemotherapy and trastuzumab in the prospective ShortHER trial.
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Dieci, M V, Bisagni, G, Brandes, A A, Frassoldati, A, Donadio, M, Garrone, O, Piacentini, F, Balduzzi, S, Guarneri, V, and Conte, P F
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ADJUVANT treatment of cancer , *BREAST cancer patients , *TRASTUZUMAB , *THEATER - Published
- 2019
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45. Antibiotic Treatment of Severe Exacerbations of Chronic Obstructive Pulmonary Disease with Procalcitonin: A Randomized Noninferiority Trial
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Alessia Verduri, Fabrizio Luppi, Roberto D'Amico, Sara Balduzzi, Roberto Vicini, Anna Liverani, Valentina Ruggieri, Mario Plebani, Maria Pia Foschino Barbaro, Antonio Spanevello, Giorgio Walter Canonica, Alberto Papi, Leonardo Michele Fabbri, Bianca Beghè, FARM58J2XH Study Group, Verduri, A, Luppi, F, D'Amico, R, Balduzzi, S, Vicini, R, Liverani, A, Ruggieri, V, Plebani, M, Barbaro, M, Spanevello, A, Canonica, G, Papi, A, Fabbri, L, and Beghè, B
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Genetics and Molecular Biology (all) ,Male ,Protein Precursor ,Antibiotics ,lcsh:Medicine ,Biochemistry ,Procalcitonin ,Pulmonary Disease, Chronic Obstructive ,Respiratory Tract Infection ,Prospective Studies ,lcsh:Science ,Aged ,Anti-Bacterial Agents ,Bacterial Infections ,Biomarkers ,Calcitonin ,Drug Administration Schedule ,Drug Monitoring ,Female ,Humans ,Italy ,Protein Precursors ,Respiratory Tract Infections ,Treatment Outcome ,Agricultural and Biological Sciences (all) ,Biochemistry, Genetics and Molecular Biology (all) ,Medicine (all) ,COPD ,Multidisciplinary ,Respiratory tract infections ,Biomarker (medicine) ,medicine.symptom ,hormones, hormone substitutes, and hormone antagonists ,Human ,Research Article ,medicine.medical_specialty ,Chronic Obstructive ,medicine.drug_class ,Calcitonin Gene-Related Peptide ,Socio-culturale ,Bacterial Infection ,Pulmonary Disease ,Anti-Bacterial Agent ,parasitic diseases ,medicine ,Intensive care medicine ,business.industry ,lcsh:R ,Biomarker ,bacterial infections and mycoses ,medicine.disease ,Pneumonia ,Prospective Studie ,Respiratory failure ,Sputum ,lcsh:Q ,business - Abstract
The duration of antibiotic treatment of exacerbations of COPD (ECOPD) is controversial. Serum procalcitonin (PCT) is a biomarker of bacterial infection used to identify the cause of ECOPD. METHODS AND FINDINGS: We investigated whether a PCT-guided plan would allow a shorter duration of antibiotic treatment in patients with severe ECOPD. For this multicenter, randomized, non-inferiority trial, we enrolled 184 patients hospitalized with ECOPD from 18 hospitals in Italy. Patients were assigned to receive antibiotics for 10 days (standard group) or for either 3 or 10 days (PCT group). The primary outcome was the rate of ECOPD at 6 months. Having planned to recruit 400 patients, we randomized only 183: 93 in the PCT group and 90 in the standard group. Thus, the completed study was underpowered. The ECOPD rate at 6 months between PCT-guided and standard antibiotic treatment was not significant (% difference, 4.04; 90% confidence interval [CI], -7.23 to 15.31), but the CI included the non-inferiority margin of 15. In the PCT-guided group, about 50% of patients were treated for 3 days, and there was no difference in primary or secondary outcomes compared to patients treated for 10 days. CONCLUSIONS: Although the primary and secondary clinical outcomes were no different for patients treated for 3 or 10 days in the PCT group, the conclusion that antibiotics can be safely stopped after 3 days in patients with low serum PCT cannot be substantiated statistically. Thus, the results of this study are inconclusive regarding the noninferiority of the PCT-guided plan compared to the standard antibiotic treatment. The study was funded by Agenzia Italiana del Farmaco (AIFA-FARM58J2XH). Clinical trial registered with www.clinicaltrials.gov (NCT01125098). TRIAL REGISTRATION: ClinicalTrials.gov NCT01125098. journal.pone.0118241 Background The duration of antibiotic treatment of exacerbations of COPD (ECOPD) is controversial. Serum procalcitonin (PCT) is a biomarker of bacterial infection used to identify the cause of ECOPD. Methods and Findings We investigated whether a PCT-guided plan would allow a shorter duration of antibiotic treatment in patients with severe ECOPD. For this multicenter, randomized, non-inferiority trial, we enrolled 184 patients hospitalized with ECOPD from 18 hospitals in Italy. Patients were assigned to receive antibiotics for 10 days (standard group) or for either 3 or 10 days (PCT group). The primary outcome was the rate of ECOPD at 6 months. Having planned to recruit 400 patients, we randomized only 183: 93 in the PCT group and 90 in the standard group. Thus, the completed study was underpowered. The ECOPD rate at 6 months between PCT-guided and standard antibiotic treatment was not significant (% difference, 4.04; 90% confidence interval [CI], -7.23 to 15.31), but the CI included the non-inferiority margin of 15. In the PCT-guided group, about 50% of patients were treated for 3 days, and there was no difference in primary or secondary outcomes compared to patients treated for 10 days. Conclusions Although the primary and secondary clinical outcomes were no different for patients treated for 3 or 10 days in the PCT group, the conclusion that antibiotics can be safely stopped after 3 days in patients with low serum PCT cannot be substantiated statistically. Thus, the results of this study are inconclusive regarding the noninferiority of the PCT-guided plan compared to the standard antibiotic treatment. The study was funded by Agenzia Italiana del Farmaco (AIFA-FARM58J2XH). Clinical trial registered with www.clinicaltrials.gov (NCT01125098).
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- 2015
46. Non-steroid agents for idiopathic pulmonary fibrosis
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Stefania Cerri, Roberto D'Amico, Cinzia Del Giovane, Sara Balduzzi, Luca Richeldi, E. Haydn Walters, Paolo Spagnolo, Fabrizio Luppi, Spagnolo, P, Del Giovane, C, Luppi, F, Cerri, S, Balduzzi, S, Walters, E, D'Amico, R, and Richeldi, L
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medicine.medical_specialty ,Pyridones ,Pulmonary Fibrosis ,Anti-Inflammatory Agents ,Cochrane Library ,Placebo ,Pirfenidone ,Pulmonary function testing ,Idiopathic pulmonary fibrosis ,Interferon-gamma ,Internal medicine ,Pulmonary fibrosis ,Azathioprine ,Medicine ,Humans ,Pharmacology (medical) ,Cyclophosphamide ,Randomized Controlled Trials as Topic ,business.industry ,Hazard ratio ,Anti-Inflammatory Agents, Non-Steroidal ,Idiopathic Pulmonary Fibrosi ,Odds ratio ,medicine.disease ,Recombinant Proteins ,Surgery ,drug therapy ,therapeutic use ,Prednisone ,business ,Non-Steroidal ,therapeutic use, Azathioprine ,therapeutic use, Colchicine ,therapeutic use, Cyclophosphamide ,therapeutic use, Humans, Immunosuppressive Agents ,therapeutic use, Interferon-gamma ,therapeutic use, Prednisone ,therapeutic use, Pulmonary Fibrosis ,drug therapy, Pyridones ,therapeutic use, Randomized Controlled Trials as Topic, Recombinant Proteins ,Colchicine ,Immunosuppressive Agents ,medicine.drug - Abstract
Background: idiopathic pulmonary fibrosis is a chronic progressive lung disease with poor outcome and no effective treatment to date. This is an update of a Cochrane Review first published in 2003. Objectives: to assess the efficacy of non-steroid agents in adults with idiopathic pulmonary fibrosis. Search methods: we searched the Cochrane Airways Group Register (30 March 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2010), Ovid MEDLINE to March week 5, 2010, EMBASE to week 13, 2010 and PubMed to April 2010, with additional handsearching, including abstracts of international conferences. We also contacted pharmaceutical companies and researchers in the field. Selection criteria: randomised studies comparing non-steroid drugs with placebo or steroids in adults with idiopathic pulmonary fibrosis. Data collection and analysis: two authors independently assessed trial quality, extracted data and assessed risk of bias. We contacted pharmaceutical companies to obtain missing information, if any. We combined survival outcomes using Peto odds ratios or hazard ratios (HR). Main results: fifteen trials involving 10 different drugs were included. Two trials enrolling 1156 patients compared interferon gamma-1beta with placebo: interferon gamma-1beta did not significantly improve survival (HR 0.88, 95% CI 0.47 to 1.64; P = 0.68). Four trials involving 1155 patients compared pirfenidone with placebo. Three trials, conducted in 1046 patients, provided data on progression-free survival: pirfenidone significantly reduced the risk of disease progression by 30% (HR 0.70, 95% CI 0.56 to 0.88, P = 0.002). Data on the effect of pirfenidone on pulmonary function could only be assessed for two studies analysing 314 patients. Forced vital capacity or vital capacity was significantly improved by pirfenidone (mean difference 0.08 L, 95% CI 0.03 to 0.13, P = 0.0006). Authors' conclusions: based on available data, partly still unpublished, pirfenidone appears to improve progression-free survival and, to a lesser extent, pulmonary function in patients with idiopathic pulmonary fibrosis. More data are needed on overall survival and quality of life on treatment. From the studies in this review, interferon gamma-1beta has not been shown to affect survival. Other agents evaluated in single studies either failed to provide evidence for a benefit or need to be assessed in larger randomised controlled trials
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- 2010
47. Neoadjuvant nivolumab and relatlimab in locally advanced MMR-deficient colon cancer: a phase 2 trial.
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de Gooyer PGM, Verschoor YL, van den Dungen LDW, Balduzzi S, Marsman HA, Geukes Foppen MH, Grootscholten C, Dokter S, den Hartog AG, Verbeek WHM, Woensdregt K, van den Broek JJ, Oosterling SJ, Schumacher TN, Kuhlmann KFD, Beets-Tan RGH, Haanen JBAG, van Leerdam ME, van den Berg JG, and Chalabi M
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Mismatch repair deficiency (dMMR) is found in approximately 15% of non-metastatic colon cancers (CCs) and is characterized by a defective DNA mismatch repair system, resulting in hypermutated and highly immunogenic tumors. Although patients with dMMR CC have limited benefit from chemotherapy, these tumors have been shown to respond exceptionally well to neoadjuvant anti-PD-1 plus anti-CTLA-4, with high rates of pathologic responses. Here, based on data from melanoma studies, we postulated a high efficacy and favorable toxicity profile of anti-PD-1 plus anti-LAG-3. In the NICHE-3 study, a total of 59 patients with locally advanced dMMR CC were treated with two 4-weekly cycles of nivolumab (480 mg) plus relatlimab (480 mg) before surgery. Pathologic response was observed in 57 of 59 (97%; 95% confidence interval (CI): 88-100%) patients, meeting the primary endpoint. Responses included 54 (92%; 95% CI: 81-97%) major pathologic responses (≤10% residual viable tumor) and 40 (68%; 95% CI: 54-79%) pathologic complete responses. With a median follow-up of 8 months (range, 2-19), one patient had recurrence of disease. The treatment displayed an acceptable safety profile, with all-grade and grade 3-4 immune-related adverse events (irAEs) occurring in 80% and 10% of patients, respectively. The most common irAEs were infusion-related reactions (29%), thyroid dysfunction (22%) and fatigue (20%). In conclusion, our results show that neoadjuvant nivolumab/relatlimab induces high rates of pathologic responses and that further investigation of this treatment in larger studies is warranted. These data add to the body of evidence in support of neoadjuvant immunotherapy regimens in dMMR CC. ClinicalTrials.gov identifier: NCT03026140 ., (© 2024. The Author(s).)
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- 2024
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48. Author Correction: Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction adenocarcinoma: the phase 2 PANDA trial.
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Verschoor YL, van de Haar J, van den Berg JG, van Sandick JW, Kodach LL, van Dieren JM, Balduzzi S, Grootscholten C, IJsselsteijn ME, Veenhof AAFA, Hartemink KJ, Vollebergh MA, Jurdi A, Sharma S, Spickard E, Owers EC, Bartels-Rutten A, den Hartog P, de Miranda NFCC, van Leerdam ME, Haanen JBAG, Schumacher TN, Voest EE, and Chalabi M
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- 2024
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49. Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction adenocarcinoma: the phase 2 PANDA trial.
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Verschoor YL, van de Haar J, van den Berg JG, van Sandick JW, Kodach LL, van Dieren JM, Balduzzi S, Grootscholten C, IJsselsteijn ME, Veenhof AAFA, Hartemink KJ, Vollebergh MA, Jurdi A, Sharma S, Spickard E, Owers EC, Bartels-Rutten A, den Hartog P, de Miranda NFCC, van Leerdam ME, Haanen JBAG, Schumacher TN, Voest EE, and Chalabi M
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- Humans, Neoadjuvant Therapy, Programmed Cell Death 1 Receptor, Esophagogastric Junction pathology, Antineoplastic Combined Chemotherapy Protocols adverse effects, Tumor Microenvironment, Adenocarcinoma drug therapy, Adenocarcinoma pathology, Stomach Neoplasms drug therapy, Stomach Neoplasms pathology, Esophageal Neoplasms, Antibodies, Monoclonal, Humanized
- Abstract
Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors (n = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46-88%) patients, including 9 (45%, 95% confidence interval 23-68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1)
+ CD8+ T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 ., (© 2024. The Author(s).)- Published
- 2024
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50. Immune landscape of breast tumors with low and intermediate estrogen receptor expression.
- Author
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Voorwerk L, Sanders J, Keusters MS, Balduzzi S, Cornelissen S, Duijst M, Lips EH, Sonke GS, Linn SC, Horlings HM, and Kok M
- Abstract
Immune checkpoint blockade (ICB) is currently approved for patients with triple-negative breast cancer (TNBC), whereas responses to ICB are also observed in a small subgroup of Estrogen Receptor (ER)-positive breast cancer. The cut-off for ER-positivity (≥1%) is based on likelihood of endocrine treatment response, but ER-positive breast cancer represents a very heterogeneous group. This raises the question whether selection based on ER-negativity should be revisited to select patients for ICB treatment in the context of clinical trials. Stromal tumor-infiltrating lymphocytes (sTILs) and other immune parameters are higher in TNBC compared to ER-positive breast cancer, but it is unknown whether lower ER levels are associated with more inflamed tumor microenvironments (TME). We collected a consecutive series of primary tumors from 173 HER2-negative breast cancer patients, enriched for tumors with ER expression between 1 and 99% and found levels of stromal TILs, CD8 + T cells, and PD-L1 positivity in breast tumors with ER 1-9% and ER 10-50% to be comparable to tumors with ER 0%. Expression of immune-related gene signatures in tumors with ER 1-9% and ER 10-50% was comparable to ER 0%, and higher than in tumors with ER 51-99% and ER 100%. Our results suggest that the immune landscape of ER low tumors (1-9%) and ER intermediate tumors (10-50%) mimic that of primary TNBC., (© 2023. The Author(s).)
- Published
- 2023
- Full Text
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