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Abstract：
BACKGROUND: Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have an extremely important impact on the treatment of hormone-sensitive breast cancer (BC) and have radically changed the first-line treatment for metastatic disease with increased rates of treatment response, overall survival (OS), and progression-free survival (PFS). We performed a pooled analysis of randomized trials to validate or refute the hypothesis that there is a significant survival benefit of adding anti-CDK4/6 inhibitors to standard endocrine therapy (ET) in older patients with advanced BC.
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.
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.
摘要：
背景：细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂对激素敏感性乳腺癌（BC）的治疗具有极其重要的影响，并从根本上改变了转移性疾病的一线治疗方法，治疗反应率增加，总生存期（OS），无进展生存期（PFS）。我们对随机试验进行了汇总分析，以验证或驳斥以下假设：在晚期BC的老年患者中，在标准内分泌治疗（ET）中添加抗CDK4/6抑制剂具有显着的生存益处。
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.
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.
