Research Papers:
A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience
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Abstract
Patrizia Vici1, Laura Pizzuti1, Andrea Michelotti2, Isabella Sperduti3, Clara Natoli4, Lucia Mentuccia5, Luigi Di Lauro1, Domenico Sergi1, Paolo Marchetti6, Daniele Santini7, Emanuela Magnolfi5, Laura Iezzi4, Luca Moscetti8, Agnese Fabbri9, Alessandra Cassano10, Antonino Grassadonia4, Claudia Omarini11, Federico Piacentini11, Andrea Botticelli6, Ilaria Bertolini2, Angelo Fedele Scinto12, Germano Zampa13, Maria Mauri14, Loretta D’Onofrio7, Valentina Sini6, Maddalena Barba1, Marcello Maugeri-Saccà1, Ernesto Rossi10, Elisabetta Landucci2, Silverio Tomao15, Antonio Maria Alberti16, Francesco Giotta17, Corrado Ficorella18, Vincenzo Adamo19, Antonio Russo20, Vito Lorusso17, Katia Cannita18, Sandro Barni21, Lucio Laudadio22, Filippo Greco23, Ornella Garrone24, Marina Della Giulia1, Paolo Marolla1, Giuseppe Sanguineti25, Barbara Di Cocco26, Gennaro Ciliberto27, Ruggero De Maria28 and Teresa Gamucci5
1Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy
2UO Oncologia Medica I, Ospedale S. Chiara, Dipartimento di oncologia, dei trapianti e delle nuove tecnologie, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
3Bio-Statistics Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy
4Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell’Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy
5Medical Oncology Unit, ASL Frosinone, Frosinone, Italy
6Medical Oncology Unit, Policlinico Sant'Andrea, Rome, Italy
7Medical Oncology, Policlinico Universitario Campus Bio-Medico, Rome, Italy
8Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy
9Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Viterbo, Italy
10Department of Medical Oncology, Catholic University of Sacred Heart, Rome, Italy
11Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy
12Medical Oncology, Ospedale San Giovanni Calibita Fatebenefratelli, Rome, Italy
13Oncology Unit, Nuovo Regina Margherita Hospital, Rome, Italy
14Division of Oncology, San Giovanni Hospital, Rome, Italy
15Department of Medico-Surgical Sciences and Biotechnologies, “Sapienza” University of Rome, Oncology Unit, Istituto Chirurgico Ortopedico Traumatologico, Latina, Italy
16Medical Oncology, Sandro Pertini Hospital, Rome, Italy
17Division of Medical Oncology, IRCCS, Giovanni Paolo II Hospital, Bari, Italy
18Medical Oncology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L’Aquila, Italy
19Medical Oncology Unit AOOR Papardo-Piemonte, Department of Human Pathology of Adult And Evolutive Age “Gaetano Barresi”, University of Messina, Messina, Italy
20Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy
21Medical Oncology, ASST Bergamo Ovest, Ospedale di Treviglio, Bergamo, Italy
22Medical Oncology, Ospedale F. Renzetti, Lanciano, Italy
23Department of Pathology, Surgery and Oncology, “Mater Salutis” Hospital, ULSS21, Verona, Italy
24Medical Oncology, A.O. Ospedale di Insegnamento S. Croce e Carle, Cuneo, Italy
25Department of Radiotherapy, IRCCS Regina Elena National Cancer Institute, Rome, Italy
26Medical Oncology, S.M. Goretti Hospital, Latina, Italy
27Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy
28Institute of General Pathology, Catholic University of the Sacred Heart, Rome, Italy
Correspondence to:
Patrizia Vici, email: [email protected]
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.
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