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

urn:hdl:2445/178654 A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study Martin Castillo, Begoña Pernas, Sònia Dorca i Sargatal, Jordi Álvarez, Isabel Martínez, Susana Pérez García, José Manuel Batista López, Norberto Rodríguez Sánchez, César A. Amillano, Kepa Domínguez, Severina Luque, Maria Stradella, Agostina Morilla, Idoia Viñas, Gemma Cortés, Javier Cuyàs, Elisabet Verdura, Sara Fernández-Ochoa, Álvaro Fernández Arroyo, Salvador Segura-Carretero, Antonio Joven, Jorge Pérez, Elsa Bosch, Maria Neus García, Margarita López Bonet, Eugeni Saidani, Samiha Buxó, Maria Menendez, Javier A. Càncer de mama Metformina Quimioteràpia Breast cancer Metformin Chemotherapy 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. 2021-06-22T15:30:11Z 2021-06-22T15:30:11Z 2018-11-02 2021-06-22T15:30:12Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.18632/oncotarget.26286 Oncotarget, 2018, vol. 9, num. 86, p. 35687-35704 https://doi.org/10.18632/oncotarget.26286 cc-by (c) Martin Castillo, Begoña et al., 2018 https://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Impact Journals Articles publicats en revistes (Ciències Clíniques)