The CDK4/6 inhibitors significantly increase progression-free survival (PFS) in ER+/HER2− advanced breast cancer patients. In clinical trials, overall survival (OS) improvement has been demonstrated for ribociclib and abemaciclib but not for palbociclib. We undertook a real-world evaluation of PFS and OS in 227 post-menopausal patients who received first-line CDK4/6 inhibitors. There is no significant difference in median PFS (27.5 months vs. 25.7 months,p= 0.3) or median OS (49.5 months vs. 50.2 months,p= 0.67) in patients who received either palbociclib or ribociclib, respectively. De novo disease is significantly associated with prolonged median PFS and median OS compared with recurrence disease (47.1 months vs. 20.3 months (p= 0.0002) and 77.4 months vs. 37.3 months (p= 0.0003), respectively). PR– tumours have significantly reduced median PFS and OS compared with PR+ disease (19.2 months vs. 38 months (p= 0.003) and 34.3 months vs. 62.6 months (p= 0.02), respectively). In the very elderly (>80 years), median PFS and OS are significantly shorter compared with patients who are 65 years or below (14.5 months vs. 30.2 months (p= 0.01), and 77.4 months vs. 29.6 months (p= 0.009), respectively) in the palbociclib group. Our data suggest that the benefit in the very elderly is limited, and PR+/de novo disease obtains the maximum survival benefit.
CDK4/6抑制剂显著延长了ER+/HER2-晚期乳腺癌患者的无进展生存期(PFS)。临床试验已证实,瑞博西利和阿贝西利可改善总生存期(OS),但哌柏西利未显示此效果。我们对227例接受一线CDK4/6抑制剂治疗的绝经后患者进行了真实世界的PFS和OS评估。结果显示,接受哌柏西利或瑞博西利治疗的患者在中位PFS(27.5个月 vs. 25.7个月,p=0.3)和中位OS(49.5个月 vs. 50.2个月,p=0.67)方面均无显著差异。与原发疾病相比,复发疾病患者的中位PFS和中位OS显著缩短(分别为47.1个月 vs. 20.3个月(p=0.0002)和77.4个月 vs. 37.3个月(p=0.0003))。与PR+疾病相比,PR-疾病患者的中位PFS和OS显著降低(分别为19.2个月 vs. 38个月(p=0.003)和34.3个月 vs. 62.6个月(p=0.02))。在哌柏西利治疗组中,高龄(>80岁)患者的中位PFS和OS显著短于65岁及以下患者(分别为14.5个月 vs. 30.2个月(p=0.01)和77.4个月 vs. 29.6个月(p=0.009))。我们的数据表明,高龄患者的获益有限,而PR+/原发疾病患者可获得最大的生存获益。