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Oncotarget. 2017 May 25;8(34):56921-56931. doi: 10.18632/oncotarget.18176. eCollection 2017 Aug 22.

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

Author information

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.

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.

KEYWORDS:

HER2 positive; T-DM1; metastatic breast cancer; previous pertuzumab; real-world

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