Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial
- Authors
- Ko, Kwang-Pil; Ma, Seung Hyun; Yang, Jae-Jeong; Hwang, Yunji; Ahn, Choonghyun; Cho, Young-Min; Noh, Dong-Young; Park, Byung-Joo; Han, Wonshik; Park, Sue K.
- Issue Date
- Sep-2015
- Publisher
- SPRINGER
- Keywords
- Metformin; Breast cancer; Glucose; Postoperative adjuvant
- Citation
- BREAST CANCER RESEARCH AND TREATMENT, v.153, no.2, pp.361 - 370
- Journal Title
- BREAST CANCER RESEARCH AND TREATMENT
- Volume
- 153
- Number
- 2
- Start Page
- 361
- End Page
- 370
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/10190
- DOI
- 10.1007/s10549-015-3519-8
- ISSN
- 0167-6806
- Abstract
- Previous observational studies have suggested that metformin in diabetes patients may reduce breast cancer risk more than the reductions from other anti-diabetes medications. This randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy of metformin for controlling physical and metabolic profiles related to prognosis and adverse events in non-diabetic breast cancer patients. Female breast cancer patients (N = 105), at least 6 months post-mastectomy, with obesity (a parts per thousand yen25 kg/m(2)) and/or pre-diabetes (fasting blood sugar levels a parts per thousand yen100 mg/dL), were randomly assigned to three groups (placebo, metformin 500 mg, and metformin 1000 mg) stratified by tamoxifen use. A linear mixed model for repeated measurements among three groups and ANOVA for profile differences during 6 months of treatment were used for the intention-to-treat analysis. The metformin 1000 mg group had a significantly greater decline in glucose and HbA1c levels between treatment weeks 0 and 6 month (p = 0.008 and 0.009, respectively), and the declines increased with an increase in body mass index (BMI) level (p interaction with BMI = 0.007 and 0.067, respectively). A marginally significant different effect from the metformin 1000 mg treatment was detected for glucose and HbA1c levels (p interaction = 0.084 and 0.063, respectively) in the intention-to-treat analysis. Metformin 1000 mg treatment had a favorable effect on controlling glucose and HbA1C levels in obese non-diabetic breast cancer patients, indicating prognostic importance. Further trials are needed to elucidate the risk-benefit ratio of long-term use of metformin.
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