Background: The quest to comprehend the real-world efficacy of CDK4/6 inhibitors (CDKis) in breast cancer continues, as patient responses vary significantly. Methods: This single-center retrospective study evaluated CDKi use outside the trial condition from November 2016 to May 2020. Progression-free survival (PFS), time-to-treatment failure (TTF), short-term and prolonged treatment benefit (≥4 and ≥10 months), as well as prognostic and predictive markers were assessed with Kaplan–Meier and multivariate regression analyses. Results: Out of 86 identified patients, 58 (67.4%) had treatment failure of which 40 (46.5%) were due to progression. Median PFS and TTF were 12 and 8.5 months, respectively. A total of 57 (66.3%) and 42 (48.8%) patients experienced short-term and prolonged treatment benefit. Independent, significant predictors for PFS were progesterone receptor expression (HR: 0.88), multiple metastatic sites (HR: 2.56), and hepatic metastasis (HR: 2.01). Significant predictors for TTF were PR expression (HR: 0.86), multiple sites (HR: 3.29), adverse events (HR: 2.35), and diabetes (HR: 2.88). Aside from tumor biology and adverse events, treatment modifications like pausing and switching of CDKi were predictive for short-term (OR: 6.73) and prolonged (OR: 14.27) therapeutic benefit, respectively. Conclusions: These findings emphasize the importance of tailored treatment strategies, highlighting the role of PR expression, metastatic burden, and therapeutic adjustments in optimizing patient outcomes in real-world breast cancer management.
背景：由于患者对CDK4/6抑制剂（CDKis）的反应存在显著差异，探索其在乳腺癌临床实践中的真实疗效具有重要意义。方法：本单中心回顾性研究评估了2016年11月至2020年5月期间临床试验条件外CDKis的使用情况。通过Kaplan-Meier法和多变量回归分析，评估了无进展生存期（PFS）、至治疗失败时间（TTF）、短期（≥4个月）与长期（≥10个月）治疗获益，以及预后和预测标志物。结果：在86例患者中，58例（67.4%）出现治疗失败，其中40例（46.5%）因疾病进展所致。中位PFS和TTF分别为12个月和8.5个月。分别有57例（66.3%）和42例（48.8%）患者获得短期和长期治疗获益。PFS的独立显著预测因素包括孕激素受体表达（HR：0.88）、多发性转移灶（HR：2.56）和肝转移（HR：2.01）。TTF的显著预测因素为PR表达（HR：0.86）、多部位转移（HR：3.29）、不良事件（HR：2.35）和糖尿病（HR：2.88）。除肿瘤生物学特征和不良事件外，暂停或更换CDKi等治疗调整分别对短期（OR：6.73）和长期（OR：14.27）治疗获益具有预测价值。结论：这些发现强调了在真实世界乳腺癌管理中制定个体化治疗策略的重要性，凸显了PR表达、转移负荷及治疗调整在优化患者预后中的关键作用。
Real-World Data Analysis of CDK4/6 Inhibitor Therapy—A Patient-Centric Single Center Study
肿瘤(癌症)患者之家