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Poster display

2156 - Trastuzumab emtansine (T-DM1) in patients (pts) with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC): Results from a multicenter retrospective analysis


10 Oct 2016


Poster display


Laura Pizzuti


Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365


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

Author affiliations

  • 1 Division Of Medical Oncology 2, Istituto Regina Elena, 00144 - Roma/IT
  • 2 Biostatistics Unit, Istituto Regina Elena, 00144 - Roma/IT
  • 3 Polo Oncologico, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 4 Department Of Medical And Surgical Sciences For Children & Adults, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41122 - Modena/IT
  • 5 Oncologia Medica, Ospedale SS Trinità, 03039 - Sora/IT
  • 6 Department Of Medical , Oral And Biotechnological Sciences, Experimental And Clinical Sciences, University G D'Annunzio, 66100 - Chieti/IT
  • 7 Department Of Medical Oncology, Libero Istituto Universitario Campus Bio-Medico (LIUCBM), 00128 - Roma/IT
  • 8 Division Of Medical Oncology, Istituto Tumori Giovanni Paolo II, Bari/IT
  • 9 Medical Oncology Unit, Ospedale Civile San Salvatore, L'Aquila/IT
  • 10 Division Of Medical Oncology, Renzetti Hospital, Lanciano/IT
  • 11 Medicina Interna - U.o.c. Di Oncologia Medica, Policlinico Universitario A. Gemelli, 00168 - Roma/IT
  • 12 Clinical And Molecular Medicine Department, Sapienza University, Sant'Andrea Hospital, 00189 - Rome/IT
  • 13 Medical Oncology Unit, Centro Oncologico Ospedale Papardo, Messina/IT
  • 14 Department Of Oncology, S Giovanni Addolorata, Roma/IT
  • 15 Medical Oncology Unit, Ospedale Fatebenefratelli - Isola Tiberina, Roma/IT
  • 16 Oncology Unit, Nuovo Regina Margherita Hospital, Rome/IT
  • 17 Medical Oncology Department, Ospedale Belcolle, ASL di Viterbo Oncology Unit, Viterbo/IT
  • 18 Medical Oncology Unit, ASL Frosinone, Frosinone/IT
  • 19 Medical Oncology Unit, Azienda Ospedaliera Treviglio-Caravaggio, 24047 - Treviglio/IT


Abstract 2156


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.

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