Abstract：
BACKGROUND: Metformin has been reported to have an anti-tumorigenic impact against metastatic breast cancer (MBC) cells through several mechanisms. Its effect can be evaluated by using many variables such as the response rate (RR) as well as the progression-free survival (PFS).
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.
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.
摘要：
背景：据报道，二甲双胍通过几种机制对转移性乳腺癌（MBC）细胞具有抗肿瘤作用。可以通过使用许多变量来评估其效果，例如响应率（RR）以及无进展生存期（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。
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。
