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A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Oncotarget, Scopus-Elsevier, Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, Oncotarget, 2018, vol. 9, núm. 86, p. 35687-35704, Articles publicats (IdIBGi), Martin Castillo, Begoña Pernas, Sonia Dorca, Joan Álvarez, Isabel Martínez, Susana Pérez Garcia, Jose 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, Neus Garcia, Margarita López Bonet, Eugeni Saidani, Samiha Buxó Pujolràs, Maria Menéndez Menéndez, Javier Abel 2018 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 9 86 35687 35704, DUGiDocs – Universitat de Girona, instname
- Publication Year :
- 2018
- Publisher :
- Impact Journals, LLC, 2018.
-
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.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
combinations
Population
Mama -- Càncer -- Tractament
News
Neutropenia
Gastroenterology
Càncer de mama
resistance
03 medical and health sciences
breast cancer
Breast cancer
0302 clinical medicine
Trastuzumab
HER2
Internal medicine
Quimioteràpia
medicine
Clinical endpoint
cancer
Chemotherapy
Metformina
education
therapy
education.field_of_study
Breast -- Cancer -- Treatment
business.industry
medicine.disease
Metformin
trastuzumab
Regimen
030104 developmental biology
Oncology
Tolerability
030220 oncology & carcinogenesis
metformin
business
Research Paper
medicine.drug
Subjects
Details
- ISSN :
- 19492553
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- Oncotarget
- Accession number :
- edsair.doi.dedup.....8d91433b4b411119bbcc0dd3f3b0d404