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Resumen de 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

Joaquín Gavilá Gregori, Juan Rafael Haba Rodríguez, Begoña Bermejo de las Heras, Álvaro Rodríguez Lescure, A. Antón Torres, Eva Ciruelos, Joan Brunet i Vidal, Eva Muñoz Couselo, Marta Santisteban Eslava, César Augusto Rodríguez Sánchez, Ana Santaballa Bertrán, Pedro Sánchez Rovira, José Ángel García Sáenz, M. Ruiz Borrego, Ángel Luis Guerrero Zotano, Marisol Huerta Alvaro, A. Cotes Sanchís, Juan Lao, E. Aguirre Ortega, Javier Cortés, Antonio Llombart Cussac

  • 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-naïve patients (31.5% versus 40.5% for L-pretreated versus L-naïve). 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.


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