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oai:recercat.cat:2445/1786542025-11-20T15:55:24Zcom_2072_1057col_2072_478798col_2072_478916col_2072_478917

00925njm 22002777a 4500 dc Martin Castillo, Begoña author Pernas, Sònia author Dorca i Sargatal, Jordi author Álvarez, Isabel author Martínez, Susana author Pérez García, José Manuel author Batista López, Norberto author Rodríguez Sánchez, César A. author Amillano, Kepa author Domínguez, Severina author Luque, Maria author Stradella, Agostina author Morilla, Idoia author Viñas, Gemma author Cortés, Javier author Cuyàs, Elisabet author Verdura, Sara author Fernández-Ochoa, Álvaro author Fernández Arroyo, Salvador author Segura-Carretero, Antonio author Joven, Jorge author Pérez, Elsa author Bosch, Maria Neus author García, Margarita author López Bonet, Eugeni author Saidani, Samiha author Buxó, Maria author Menendez, Javier A. author 2021-06-22T15:30:11Z 2021-06-22T15:30:11Z 2018-11-02 2021-06-22T15:30:12Z The METTEN study assessed the efficacy, tolerability, and safety of adding metformin to neoadjuvant chemotherapy plus trastuzumab in early HER2-positive breast cancer (BC). Women with primary, non-metastatic HER2-positive BC were randomized (1:1) to receive metformin (850 mg twice-daily) for 24 weeks concurrently with 12 cycles of weekly paclitaxel plus trastuzumab, followed by four cycles of 3-weekly FE75C plus trastuzumab (arm A), or equivalent regimen without metformin (arm B), followed by surgery. Primary endpoint was the rate of pathological complete response (pCR) in the per-protocol efficacy population. pCR rate was numerically higher in the metformin-containing arm A (19 of 29 patients [65.5%, 95% CI: 47.3-80.1]) than in arm B (17 of 29 patients [58.6%, 95% CI: 40.7-74.5]; OR 1.34 [95% CI: 0.46-3.89], P = 0.589). The rate of breast-conserving surgery was 79.3% and 58.6% in arm A and B (P = 0.089), respectively. Blood metformin concentrations (6.2 μmol/L, 95% CI: 3.6-8.8) were within the therapeutic range. Seventy-six percent of patients completed the metformin-containing regimen; 13% of patients in arm A dropped out because of metformin-related gastrointestinal symptoms. The most common adverse events (AEs) of grade ≥3 were neutropenia in both arms and diarrhea in arm A. None of the serious AEs was deemed to be metformin-related. Addition of anti-diabetic doses of metformin to a complex neoadjuvant regimen was well tolerated and safe. Because the study was underpowered relative to its primary endpoint, the efficacy data should be interpreted with caution. Càncer de mama Metformina Quimioteràpia Breast cancer Metformin Chemotherapy A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study