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http://hdl.handle.net/2445/178654
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DC Field | Value | Language |
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dc.contributor.author | Martin Castillo, Begoña | - |
dc.contributor.author | Pernas, Sònia | - |
dc.contributor.author | Dorca i Sargatal, Jordi | - |
dc.contributor.author | Álvarez, Isabel | - |
dc.contributor.author | Martínez, Susana | - |
dc.contributor.author | Pérez García, José Manuel | - |
dc.contributor.author | Batista López, Norberto | - |
dc.contributor.author | Rodríguez Sánchez, César A. | - |
dc.contributor.author | Amillano, Kepa | - |
dc.contributor.author | Domínguez, Severina | - |
dc.contributor.author | Luque, Maria | - |
dc.contributor.author | Stradella, Agostina | - |
dc.contributor.author | Morilla, Idoia | - |
dc.contributor.author | Viñas, Gemma | - |
dc.contributor.author | Cortés, Javier | - |
dc.contributor.author | Cuyàs, Elisabet | - |
dc.contributor.author | Verdura, Sara | - |
dc.contributor.author | Fernández-Ochoa, Álvaro | - |
dc.contributor.author | Fernández Arroyo, Salvador | - |
dc.contributor.author | Segura-Carretero, Antonio | - |
dc.contributor.author | Joven, Jorge | - |
dc.contributor.author | Pérez, Elsa | - |
dc.contributor.author | Bosch, Maria Neus | - |
dc.contributor.author | García, Margarita | - |
dc.contributor.author | López Bonet, Eugeni | - |
dc.contributor.author | Saidani, Samiha | - |
dc.contributor.author | Buxó, Maria | - |
dc.contributor.author | Menendez, Javier A. | - |
dc.date.accessioned | 2021-06-22T15:30:11Z | - |
dc.date.available | 2021-06-22T15:30:11Z | - |
dc.date.issued | 2018-11-02 | - |
dc.identifier.issn | 1949-2553 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178654 | - |
dc.description.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. | - |
dc.format.extent | 18 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Impact Journals | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.18632/oncotarget.26286 | - |
dc.relation.ispartof | Oncotarget, 2018, vol. 9, num. 86, p. 35687-35704 | - |
dc.relation.uri | https://doi.org/10.18632/oncotarget.26286 | - |
dc.rights | cc-by (c) Martin Castillo, Begoña et al., 2018 | - |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Càncer de mama | - |
dc.subject.classification | Metformina | - |
dc.subject.classification | Quimioteràpia | - |
dc.subject.other | Breast cancer | - |
dc.subject.other | Metformin | - |
dc.subject.other | Chemotherapy | - |
dc.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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 685784 | - |
dc.date.updated | 2021-06-22T15:30:12Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 30479698 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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File | Description | Size | Format | |
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685784.pdf | 1.73 MB | Adobe PDF | View/Open |
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