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A retrospective, multicenter study of the efficacy of lapatinib plus trastuzumab in HER2-positive metastatic breast cancer patients previously treated with trastuzumab, lapatinib, or both: the Trastyvere study

Autores: Gavila, J.; De La Haba, J. ; Bermejo, B.; Rodríguez-Lescure, A.; Antón, A. ; Ciruelos, E.; Brunet, J. ; Muñoz-Couselo, E.; Santisteban Eslava, Marta; Rodríguez Sánchez, C. A.; Santaballa, A. ; Sánchez Rovira, P.; García Sáenz, J. A.; Ruiz-Borrego, M.; Guerrero-Zotano, A. L.; Huerta, M.; Cotes-Sanchís, A.; Romera, J. L.; Aguirre, E. ; Cortés, J.; Llombart-Cussac, A. (Autor de correspondencia)
ISSN: 1699-048X
Volumen: 22
Número: 3
Páginas: 420 - 428
Fecha de publicación: 2020
Purpose To evaluate the efficacy and safety of lapatinib (L) and trastuzumab (T) combination in HER2-positive metastatic breast cancer (MBC) patients previously treated with T and/or L. Materials and methods We conducted a retrospective, post-authorized, multicenter study including patients with HER2-positive MBC or locally advanced breast cancer (ABC) treated with the combination of L-T. Concomitant endocrine therapy, as well as brain metastasis and/or prior exposure to L, were allowed. Results One hundred and fifteen patients from 14 institutions were included. The median age was 59.8 years. The median number of prior T regimens in the advanced setting was 3 and 73 patients had received a prior L regimen. The clinical benefit rate (CBR) was 34.8% (95% CI 26.1-43.5). Among other efficacy endpoints, the overall response rate was 21.7%, and median progression-free survival (PFS) and overall survival were 3.9 and 21.6 months, respectively. Heavily pretreated and >= 3 metastatic organ patients showed lower CBR and PFS than patients with a low number of previous regimens and < 3 metastatic organs. Moreover, CBR did not significantly change in L-pretreated compared with L-naive patients (31.5% versus 40.5% for L-pretreated versus L-naive). Grade 3/4 adverse events were reported in 19 patients (16.5%). Conclusion The combination of L-T is an effective and well-tolerated regimen in heavily pretreated patients and remains active among patients progressing on prior L-based therapy. Our study suggests that the L-T regimen is a safe and active chemotherapy-free option for MBC patients previously treated with T and/or L.