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A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience

2017; Impact Journals LLC; Volume: 8; Issue: 34 Linguagem: Italiano

10.18632/oncotarget.18176

1949-2553

Patrizia Vici, Laura Pizzuti, Andrea Michelotti, Isabella Sperduti, Clara Natoli, Lucia Mentuccia, Luigi Di Lauro, Domenico Sergi, Paolo Marchetti, Daniele Santini, Emanuela Magnolfi, Laura Iezzi, Luca Moscetti, Agnese Fabbri, Alessandra Cassano, Antonino Grassadonia, Claudia Omarini, Federico Piacentini, Andrea Botticelli, Ilaria Bertolini, Angelo Fedele Scinto, G. Zampa, Maria Mauri, Loretta D’Onofrio, Valentina Sini, Maddalena Barba, Marcello Maugeri‐Saccà, Ernesto Rossi, Elisabetta Landucci, Silverio Tomao, Antonio Alberti, Francesco Giotta, Corrado Ficorella, Vincenzo Adamo, Antonio Russo, Vito Lorusso, Katia Cannita, Sandro Barni, Lucio Laudadio, Filippo Greco, Ornella Garrone, Marina Della Giulia, Paolo Marolla, Giuseppe Sanguineti, Barbara Di Cocco, Gennaro Ciliberto, Ruggero De Maria, Teresa Gamucci,

Monoclonal and Polyclonal Antibodies Research

// Patrizia Vici 1 , Laura Pizzuti 1 , Andrea Michelotti 2 , Isabella Sperduti 3 , Clara Natoli 4 , Lucia Mentuccia 5 , Luigi Di Lauro 1 , Domenico Sergi 1 , Paolo Marchetti 6 , Daniele Santini 7 , Emanuela Magnolfi 5 , Laura Iezzi 4 , Luca Moscetti 8 , Agnese Fabbri 9 , Alessandra Cassano 10 , Antonino Grassadonia 4 , Claudia Omarini 11 , Federico Piacentini 11 , Andrea Botticelli 6 , Ilaria Bertolini 2 , Angelo Fedele Scinto 12 , Germano Zampa 13 , Maria Mauri 14 , Loretta D'Onofrio 7 , Valentina Sini 6 , Maddalena Barba 1 , Marcello Maugeri-Saccà 1 , Ernesto Rossi 10 , Elisabetta Landucci 2 , Silverio Tomao 15 , Antonio Maria Alberti 16 , Francesco Giotta 17 , Corrado Ficorella 18 , Vincenzo Adamo 19 , Antonio Russo 20 , Vito Lorusso 17 , Katia Cannita 18 , Sandro Barni 21 , Lucio Laudadio 22 , Filippo Greco 23 , Ornella Garrone 24 , Marina Della Giulia 1 , Paolo Marolla 1 , Giuseppe Sanguineti 25 , Barbara Di Cocco 26 , Gennaro Ciliberto 27 , Ruggero De Maria 28 and Teresa Gamucci 5 1 Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy 2 UO Oncologia Medica I, Ospedale S. Chiara, Dipartimento di oncologia, dei trapianti e delle nuove tecnologie, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy 3 Bio-Statistics Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy 4 Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell'Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy 5 Medical Oncology Unit, ASL Frosinone, Frosinone, Italy 6 Medical Oncology Unit, Policlinico Sant'Andrea, Rome, Italy 7 Medical Oncology, Policlinico Universitario Campus Bio-Medico, Rome, Italy 8 Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy 9 Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy 10 Department of Medical Oncology, Catholic University of Sacred Heart, Rome, Italy 11 Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy 12 Medical Oncology, Ospedale San Giovanni Calibita Fatebenefratelli, Rome, Italy 13 Oncology Unit, Nuovo Regina Margherita Hospital, Rome, Italy 14 Division of Oncology, San Giovanni Hospital, Rome, Italy 15 Department of Medico-Surgical Sciences and Biotechnologies, "Sapienza" University of Rome, Oncology Unit, Istituto Chirurgico Ortopedico Traumatologico, Latina, Italy 16 Medical Oncology, Sandro Pertini Hospital, Rome, Italy 17 Division of Medical Oncology, IRCCS, Giovanni Paolo II Hospital, Bari, Italy 18 Medical Oncology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy 19 Medical Oncology Unit AOOR Papardo-Piemonte, Department of Human Pathology of Adult And Evolutive Age "Gaetano Barresi", University of Messina, Messina, Italy 20 Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy 21 Medical Oncology, ASST Bergamo Ovest, Ospedale di Treviglio, Bergamo, Italy 22 Medical Oncology, Ospedale F. Renzetti, Lanciano, Italy 23 Department of Pathology, Surgery and Oncology, "Mater Salutis" Hospital, ULSS21, Verona, Italy 24 Medical Oncology, A.O. Ospedale di Insegnamento S. Croce e Carle, Cuneo, Italy 25 Department of Radiotherapy, IRCCS Regina Elena National Cancer Institute, Rome, Italy 26 Medical Oncology, S.M. Goretti Hospital, Latina, Italy 27 Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy 28 Institute of General Pathology, Catholic University of the Sacred Heart, Rome, Italy Correspondence to: Patrizia Vici, email: patrizia.vici@ifo.gov.it Keywords: metastatic breast cancer, HER2 positive, T-DM1, previous pertuzumab, real-world Received: March 07, 2017 Accepted: April 21, 2017 Published: May 25, 2017 ABSTRACT We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab-pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab-pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival benefit (p<0.0001), while overall survival was positively affected by lower ECOG PS (p<0.0001), absence of brain metastases (p 0.05), and clinical benefit (p<0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to confirm and interpret our data on apparently lower T-DM1 efficacy when given as second-line treatment after pertuzumab, and on the optimal sequence order.