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dc.contributor.authorMartin Castillo, Begoña-
dc.contributor.authorPernas, Sònia-
dc.contributor.authorDorca i Sargatal, Jordi-
dc.contributor.authorÁlvarez, Isabel-
dc.contributor.authorMartínez, Susana-
dc.contributor.authorPérez García, José Manuel-
dc.contributor.authorBatista López, Norberto-
dc.contributor.authorRodríguez Sánchez, César A.-
dc.contributor.authorAmillano, Kepa-
dc.contributor.authorDomínguez, Severina-
dc.contributor.authorLuque, Maria-
dc.contributor.authorStradella, Agostina-
dc.contributor.authorMorilla, Idoia-
dc.contributor.authorViñas, Gemma-
dc.contributor.authorCortés, Javier-
dc.contributor.authorCuyàs, Elisabet-
dc.contributor.authorVerdura, Sara-
dc.contributor.authorFernández-Ochoa, Álvaro-
dc.contributor.authorFernández Arroyo, Salvador-
dc.contributor.authorSegura-Carretero, Antonio-
dc.contributor.authorJoven, Jorge-
dc.contributor.authorPérez, Elsa-
dc.contributor.authorBosch, Maria Neus-
dc.contributor.authorGarcía, Margarita-
dc.contributor.authorLópez Bonet, Eugeni-
dc.contributor.authorSaidani, Samiha-
dc.contributor.authorBuxó, Maria-
dc.contributor.authorMenendez, Javier A.-
dc.description.abstractThe 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.-
dc.format.extent18 p.-
dc.publisherImpact Journals-
dc.relation.isformatofReproducció del document publicat a:
dc.relation.ispartofOncotarget, 2018, vol. 9, num. 86, p. 35687-35704-
dc.rightscc-by (c) Martin Castillo, Begoña et al., 2018-
dc.subject.classificationCàncer de mama-
dc.subject.otherBreast cancer-
dc.titleA phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study-
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Ciències Clíniques)

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