METHODS: A prospective study was conducted to investigate and estimate the metformin effect on MBC. About 107 subjects were included in the study and were divided into two groups: Group A included non-diabetic MBC patients treated with metformin in conjunction with chemotherapy and group B included those treated with chemotherapy alone. Both PFS and RR were used as a criteria to evaluate the treatment outcome. Associated adverse effects of metformin were also assessed.
RESULTS: The average age of the participants in group A and group B was 50 vs. 47.5, respectively. No significant differences were detected between both cohorts concerning RR levels (regression disease (RD) 27.8% vs. 12.5%, stationary disease (SD) 44.4% vs. 41.7%, progression disease (PD) 27.8% vs. 45.8%, respectively, p = 0.074). Moreover, PFS showed no significant difference between both groups (p = 0.753). There was no significant correlation between metformin concentration and their adverse effects on the study participants.
CONCLUSIONS: Metformin as an adjuvant therapy to MBC undergoing chemotherapy showed no significant survival benefit as determined by RR and PFS.
方法:进行了一项前瞻性研究,以调查和评估二甲双胍对MBC的影响。该研究包括约107名受试者,并分为两组:A组包括接受二甲双胍联合化疗治疗的非糖尿病MBC患者,B组包括仅接受化疗治疗的患者。PFS和RR均被用作评估治疗结果的标准。还评估了二甲双胍的相关不良反应。
结果:A组和B组参与者的平均年龄分别为50岁和分别为47.5。关于RR水平,两个队列之间没有检测到显着差异(回归疾病(RD)27.8%与12.5%,静止性疾病(SD)44.4%vs.41.7%,进展性疾病(PD)27.8%vs.45.8%,分别,p=0.074)。此外,两组间PFS无显著差异(p=0.753)。二甲双胍浓度与其对研究参与者的不良反应之间没有显着相关性。
结论:二甲双胍作为接受化疗的MBC的辅助治疗,其RR和PFS没有显著的生存获益。