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2018-11-02

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cc-by (c) Martin Castillo, Begoña et al., 2018
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/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

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https://doi.org/10.18632/oncotarget.26286

Resum

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.

Matèries

Càncer de mama, Metformina, Quimioteràpia

Matèries (anglès)

Breast cancer, Metformin, Chemotherapy

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Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

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.. A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study. _Oncotarget_. 2018. Vol. 9, núm. 86, pàgs. 35687-35704. [consulta: 25 de febrer de 2026]. ISSN: 1949-2553. [Disponible a: https://hdl.handle.net/2445/178654]

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