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.
Efficacy and safety of T-DM1 in the 'common-practice' of HER2+ advanced breast cancer setting: A multicenter study / Fabi, Alessandra; DE LAURENTIIS, Michelino; Caruso, Michele; Valle, Enrichetta; Moscetti, Luca; Santini, Daniele; Cannita, Katia; Carbognin, Luisa; Ciccarese, Mariangela; Rossello, Rosalba; Arpino, Grazia; Leonardi, Vita; Montemurro, Filippo; La Verde, Nicla; Generali, Daniele; Zambelli, Alberto; Scandurra, Giuseppa; Russillo, Michelangelo; Paris, Ida; D'Ottavio, Anna Maria; Filippelli, Gianfranco; Giampaglia, Marianna; Stani, Simonetta; Fabbri, Agnese; Alesini, Daniele; Cianniello, Daniela; Giannarelli, Diana; Cognetti, Francesco. - In: ONCOTARGET. - ISSN 1949-2553. - 8:38(2017), pp. 64481-64489. [10.18632/oncotarget.16373]
Efficacy and safety of T-DM1 in the 'common-practice' of HER2+ advanced breast cancer setting: A multicenter study
DE LAURENTIIS, MICHELINO;ARPINO, GRAZIA;CIANNIELLO, DANIELA;
2017
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
