Efficacy and safety of T-DM1 in the 'common-practice' of HER2+ advanced breast cancer setting: a multicenter study

A. Fabi, M. De Laurentiis, M. Caruso, E. Valle, L. Moscetti, D. Santini, K. Cannita, L. Carbognin, M. Ciccarese, R. Rossello, G. Arpino, V. Leonardi, F. Montemurro, N. La Verde, D. Generali, A. Zambelli, G. Scandurra, M. Russillo, I. Paris, A. M. D'OttavioG. Filippelli, M. Giampaglia, S. Stani, A. Fabbri, D. Alesini, D. Cianniello, D. Giannarelli, F. Cognetti

Research output: Contribution to journalArticle


Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer (mBC). The aim of this 'field-practice' study was to investigate the efficacy and safety of T-DM1, focusing on treatment line, previous lapatinib treatment and patterns of metastasis. Three hundred and three patients with HER2-positive mBC who received T-DM1 were identified by reviewing the medical records of 24 Italian Institutions. One hundred fourty-nine (49%) and 264 (87%) had received prior hormonal treatment and/or anti-HER2 targeted therapy, respectively. Particularly, 149 patients had been previously treated with lapatinib. The objective response rate (ORR) was 36.2%, and 44.5% when T-DM1 was administrated as second-line therapy. Considering only patients with liver metastases, the ORR was 44.4%. The median progression-free survival (PFS) was 7.0 months in the overall population, but it reached 9.0 and 12.0 months when TDM-1 was administered as second- and third-line treatment, respectively.In conclusion, in this 'real-word' study evaluating the effects of T-DM1 in patients with HER2-positive mBC who progressed on prior anti-HER2 therapies, we observed a clinically-relevant benefit in those who had received T-DM1 in early metastatic treatment-line and in subjects previously treated with lapatinib.
Original languageEnglish
Pages (from-to)64481-64489
Number of pages9
Issue number38
Publication statusPublished - 2017


  • HER2
  • ado-trastuzumab emtansine
  • metastatic breast cancer
  • taxane
  • trastuzumab

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    Fabi, A., Laurentiis, M. D., Caruso, M., Valle, E., Moscetti, L., Santini, D., Cannita, K., Carbognin, L., Ciccarese, M., Rossello, R., Arpino, G., Leonardi, V., Montemurro, F., Verde, N. L., Generali, D., Zambelli, A., Scandurra, G., Russillo, M., Paris, I., ... Cognetti, F. (2017). Efficacy and safety of T-DM1 in the 'common-practice' of HER2+ advanced breast cancer setting: a multicenter study. Oncotarget, 8(38), 64481-64489. https://doi.org/10.18632/oncotarget.16373 [doi]