275P - Trastuzumab emtansine (T-DM1) in patients (pts) with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC): Resul...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer
Presenter Laura Pizzuti
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors L. Pizzuti1, I. Sperduti2, A. Michelotti3, C. Omarini4, T. Gamucci5, C. Natoli6, L. D'Onofrio7, F. Giotta8, C. Ficorella9, L. Laudadio10, A. Cassano11, P. Marchetti12, V. Adamo13, M. Mauri14, A.F. Scinto15, G. Zampa16, A. Fabbri17, L. Mentuccia18, S. Barni19, P. Vici1
  • 1Division Of Medical Oncology 2, Istituto Regina Elena, 00144 - Roma/IT
  • 2Biostatistics Unit, Istituto Regina Elena, 00144 - Roma/IT
  • 3Polo Oncologico, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 4Department Of Medical And Surgical Sciences For Children & Adults, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41122 - Modena/IT
  • 5Oncologia Medica, Ospedale SS Trinità, 03039 - Sora/IT
  • 6Department Of Medical , Oral And Biotechnological Sciences, Experimental And Clinical Sciences, University G D'Annunzio, 66100 - Chieti/IT
  • 7Department Of Medical Oncology, Libero Istituto Universitario Campus Bio-Medico (LIUCBM), 00128 - Roma/IT
  • 8Division Of Medical Oncology, Istituto Tumori Giovanni Paolo II, Bari/IT
  • 9Medical Oncology Unit, Ospedale Civile San Salvatore, L'Aquila/IT
  • 10Division Of Medical Oncology, Renzetti Hospital, Lanciano/IT
  • 11Medicina Interna - U.o.c. Di Oncologia Medica, Policlinico Universitario A. Gemelli, 00168 - Roma/IT
  • 12Clinical And Molecular Medicine Department, Sapienza University, Sant'Andrea Hospital, 00189 - Rome/IT
  • 13Medical Oncology Unit, Centro Oncologico Ospedale Papardo, Messina/IT
  • 14Department Of Oncology, S Giovanni Addolorata, Roma/IT
  • 15Medical Oncology Unit, Ospedale Fatebenefratelli - Isola Tiberina, Roma/IT
  • 16Oncology Unit, Nuovo Regina Margherita Hospital, Rome/IT
  • 17Medical Oncology Department, Ospedale Belcolle, ASL di Viterbo Oncology Unit, Viterbo/IT
  • 18Medical Oncology Unit, ASL Frosinone, Frosinone/IT
  • 19Medical Oncology Unit, Azienda Ospedaliera Treviglio-Caravaggio, 24047 - Treviglio/IT



T-DM1 improved outcomes in pts with HER2+ MBC, but few data concerning its use in routine clinical practice are available.


We retrospectively enrolled 194 HER2+ (IHC 3+ or 2+ amplified) MBC pts treated with T-DM1 in real-world practice in 20 Italian oncologic centers.


Baseline pts and tumors characteristics are listed in Tab 1. Median (m) follow up was 9.8 months (mo) (range,2-37), m T-DM1 treatment duration was 5 mo (range, 1-30). Among 183 evaluable pts, 5.4% had a complete response and 35% a partial response, for an Overall Response Rate of 40% (95%CI, 33-47). A stable disease (SD) was recorded in 26.8% pts, with a clinical benefit (CB: response or SD lasting ≥ 6 mo) of 55% (95%CI, 47-62). No significant differences in responses have emerged according to disease sites. M Progression Free Survival (PFS) was 6 mo (95%CI, 5-7), m Overall Survival (OS) was 35 mo (95%CI, 11-59). Pts who have previously carried out ≤3 lines for MBC had improved PFS (p = 0.006). At multivariate analysis, factors related to PFS benefit were lower ECOG performance status (PS) (p 


In this real-world setting of heterogeneous HER2+ MBC pts, efficacy of T-DM1 was comparable with that reported in phase II-III studies, without new safety issues.

Clinical trial identification

Legal entity responsible for the study

Patrizia Vici




All authors have declared no conflicts of interest.