文章：

CDK4/6抑制剂联合内分泌疗法治疗早期HR+/HER2−乳腺癌：III期试验的最新荟萃分析

CDK4/6 Inhibitors Plus Endocrine Therapy in Early-Stage HR+/HER2− Breast Cancer: Updated Meta-Analysis of Phase III Trials

原文发布日期：1 November 2025

DOI: 10.3390/cancers17213538

类型: Article

开放获取: 是

英文摘要：

Background/Objectives: This meta-analysis aimed to evaluate the efficacy of combining CDK4/6i with ET, compared with ET alone, in improving invasive disease-free survival (iDFS), distant recurrence-free survival (DRFS), and overall survival (OS) in early-stage hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2−) breast cancer. Given the inconclusive findings of previous meta-analyses, an updated synthesis of the latest phase III trial data was performed. Methods: A systematic review and meta-analysis were conducted following PRISMA guidelines. Randomized Controlled Trials (RCTs) comparing CDK4/6i plus ET versus ET alone were identified through PubMed, Scopus, and ClinicalTrials.gov. Hazard ratios and adverse events were analyzed using appropriate statistical models. Results: Four RCTs (monarchE, NATALEE, PENELOPE-B, PALLAS) including 17,749 patients were analyzed. CDK4/6 inhibitors improved iDFS (HR 0.80; 95% CI: 0.67–0.96;p= 0.01), while a strong trend toward improved DRFS was observed (HR 0.79; 95% CI: 0.61–1.02;p= 0.07), suggesting a potential clinically relevant benefit that requires longer follow-up to confirm. The effect on OS (HR 0.95; 95% CI: 0.79–1.16;p= 0.63) remains inconclusive. Adverse events, including neutropenia and diarrhea, were more frequent with CDK4/6i. Conclusions: The addition of CDK4/6i to ET improves iDFS and shows a favorable trend in DRFS in early-stage HR+/HER2− breast cancer, highlighting the need for longer follow-up to clarify their long-term benefit.

摘要翻译： 

背景/目的：本荟萃分析旨在评估CDK4/6抑制剂联合内分泌治疗对比单用内分泌治疗，在改善早期激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者的无浸润性疾病生存期、无远处复发生存期和总生存期方面的疗效。鉴于既往荟萃分析结论尚不明确，本研究对最新的III期临床试验数据进行了更新汇总。方法：研究遵循PRISMA指南进行系统综述和荟萃分析。通过检索PubMed、Scopus及ClinicalTrials.gov数据库，筛选出比较CDK4/6抑制剂联合内分泌治疗与单用内分泌治疗的随机对照试验。采用适当的统计模型分析风险比及不良事件。结果：共纳入四项随机对照试验（monarchE、NATALEE、PENELOPE-B、PALLAS），涉及17,749例患者。CDK4/6抑制剂可改善无浸润性疾病生存期（风险比0.80；95%置信区间：0.67–0.96；p=0.01），同时在改善无远处复发生存期方面呈现显著趋势（风险比0.79；95%置信区间：0.61–1.02；p=0.07），提示其可能具有临床相关获益，但需更长时间随访予以确认。对总生存期的影响尚不明确（风险比0.95；95%置信区间：0.79–1.16；p=0.63）。CDK4/6抑制剂组不良事件（包括中性粒细胞减少和腹泻）发生率更高。结论：在早期激素受体阳性/人表皮生长因子受体2阴性乳腺癌治疗中，CDK4/6抑制剂联合内分泌治疗可改善无浸润性疾病生存期，并在无远处复发生存期方面呈现有利趋势，但需更长期随访以明确其远期获益。

原文链接：

CDK4/6 Inhibitors Plus Endocrine Therapy in Early-Stage HR+/HER2− Breast Cancer: Updated Meta-Analysis of Phase III Trials