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Title: A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study
Author: 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.
Keywords: Càncer de mama
Breast cancer
Issue Date: 2-Nov-2018
Publisher: Impact Journals
Abstract: 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.
Note: Reproducció del document publicat a:
It is part of: Oncotarget, 2018, vol. 9, num. 86, p. 35687-35704
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ISSN: 1949-2553
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Ciències Clíniques)

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