METHODS: We selected only English-language phase II/III randomized controlled trials that compared ET alone with ET with anti-CDK4/6 inhibitors in the treatment of advanced BC, with subgroups reporting the outcomes of elderly patients (usually at least 65 years). The primary endpoint was OS.
RESULTS: The review process led to the inclusion of 12 articles and two meeting abstracts, including a total of 10 trials. The addition of CDK4/6 inhibitors to ET (letrozole or fulvestrant) significantly reduced mortality risk by 20% in younger patients (fixed-effect model; HR 0.80; 95% CI 0.72-0.9; p < 0.01) and 21% in older BC patients (HR 0.79; 95% CI 0.69-0.91; p < 0.01). No OS data were available for patients ≥70 years.
CONCLUSIONS: This large, pooled analysis is the first to demonstrate that CDK4/6 inhibitors confer OS and PFS benefits in elderly patients (those aged ≥65 years) with advanced ER + BC and to indicate that it should be discussed with and offered to all patients after geriatric assessment and according to the toxicity profile.
方法:我们仅选择了英语II/III期随机对照试验,这些试验比较了ET单独与ET联合抗CDK4/6抑制剂治疗晚期BC的疗效,亚组报告老年患者(通常至少65岁)的结局。主要终点是OS。
结果:审查过程导致包括12篇文章和两个会议摘要,包括总共10次试验。在ET(来曲唑或氟维司群)中添加CDK4/6抑制剂可显著降低年轻患者的死亡风险20%(固定效应模型;HR0.80;95%CI0.72-0.9;p<0.01)和老年BC患者的21%(HR0.79;95%CI0.69-0.91;p<0.01)。对于≥70岁的患者,没有OS数据。
结论:这个大,汇总分析首次证明CDK4/6抑制剂可在ER+BC晚期的老年患者(年龄≥65岁的患者)中获得OS和PFS益处,并表明应在进行老年评估后并根据毒性概况与所有患者进行讨论并提供给所有患者.