JAMA:二甲双胍对非糖尿病乳腺癌患者侵袭性疾病生存率的影响

2022-05-28 zhangfan MedSci原创

对于非糖尿病乳腺癌患者,在标准治疗方案基础上加入二甲双胍不能改善患者预后。

二甲双胍是治疗II型糖尿病的常用药物。一项涉及糖尿病乳腺癌患者的观察性研究中发现,二甲双胍与改善部分亚型乳腺癌预后有关。二甲双胍可改善非糖尿病乳腺癌患者肥胖相关生理机能,其他与二甲双胍抗癌相关的机制包括磷脂酰肌醇3激酶(PI3K)和RAS途径减少胰岛素信号以及直接的抗肿瘤作用(如肝激酶B1 [LKB1]介导的AMP活化蛋白激酶[AMPK]激活, PI3K蛋白激酶B负调控哺乳动物雷帕霉素靶点[mTOR]信号通路和蛋白质合成等)。 近日研究人员开展MA.32研究,考察了在非糖尿病乳腺癌患者中,二甲双胍辅助治疗对患者预后的影响。

MA.32是一项III期随机、安慰剂对照、双盲试验,在加拿大、瑞士、美国和英国进行,3649名接受标准治疗的非转移性乳腺癌患者参与,根据患者激素受体(雌激素受体和/或孕激素受体,ER/PgR)、体重指数以及人表皮生长因子受体2状态分层,在标准治疗方案基础上,随机接受850 mg二甲双胍,每日口服2次(n=1824)或安慰剂(n=1825)持续5年。研究的主要终点为激素受体阳性(ER/PgR+)乳腺癌患者的无侵袭性疾病生存率。次要终点包括总生存率、无远端复发生存率和无复发时间。

患者平均年龄52.4岁,所有患者均纳入终点分析。ER/PgR+组的中位随访时间为96.2个月。465名ER/PgR+患者实现无侵袭性疾病生存。二甲双胍组无侵袭性疾病生存率为2.78/100患者年,而安慰剂组为2.74/100患者年(比值比1.01),二甲双胍组死亡率为1.46/100患者年,安慰剂组为1.32/100患者年(HR=1.10)。ER/PgR−组随访时间为94.1个月,无侵袭性疾病生存率分别为每100患者年3.58例和3.60例(HR,1.01)。3个次要结果差异不显著。二甲双胍组患者发生3级非血液学毒性事件的风险高于安慰剂(21.5% vs 17.5%)。最常见的3级或以上不良事件为高血压(2.4% vs 1.9%)、月经不调(1.5% vs 1.4%)和腹泻(1.9% vs 7.0%)。

二甲双胍 vs 安慰剂对患者预后的影响

研究认为,对于非糖尿病乳腺癌患者,在标准治疗方案基础上加入二甲双胍不能改善患者预后

 

原始出处:

Pamela J. Goodwin et al. Effect of Metformin vs Placebo on Invasive Disease–Free Survival in Patients With Breast Cancer The MA.32 Randomized Clinical Trial .JAMA, May 24/31, 2022.

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    2022-05-29 sunyl07
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    2022-05-27 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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