Background: Metastatic HR+/HER2- breast cancer is commonly treated with CDK4/6 inhibitors in combination with endocrine therapy. However, the efficacy and safety of this approach in elderly patients (≥70 years) remain unclear, particularly in the context of real-world clinical practice. This study aims to evaluate the clinical outcomes and tolerability of CDK4/6 inhibitor treatments in this fragile population, which is often under-represented in randomized clinical trials. Patients and methods: This retrospective multicenter study included elderly patients with metastatic HR+/HER2-negative breast cancer receiving first-line CDK4/6 inhibitors. The primary endpoint was progression-free survival (PFS). The secondary endpoints focused on the overall survival (OS), safety, and tolerability, considering variables such as tumor subtype, age, comorbidities, and treatment specifics. Results: The median PFS and OS were slightly lower than those reported in clinical trials, reflecting the inclusion of a more fragile population. The luminal B subtype was linked to a poorer PFS, while other factors like age, BMI, and ECOG status did not significantly affect the outcomes. A safety analysis indicated a higher incidence of grade 3 or higher toxicities, especially in frail patients, leading to dose reductions. Despite these challenges, CDK4/6 inhibitors were generally well-tolerated, allowing most patients to continue therapy. Conclusions: CDK4/6 inhibitors with endocrine therapy are effective in elderly patients with metastatic HR+/HER2- breast cancer, though careful management is crucial to balance efficacy and minimize adverse events.
背景：转移性HR+/HER2-乳腺癌通常采用CDK4/6抑制剂联合内分泌疗法进行治疗。然而，该方法在老年患者（≥70岁）中的疗效和安全性仍不明确，尤其是在真实世界临床实践中。本研究旨在评估这一在随机临床试验中代表性不足的脆弱人群接受CDK4/6抑制剂治疗的临床结果和耐受性。 患者与方法：这项回顾性多中心研究纳入了接受一线CDK4/6抑制剂治疗的转移性HR+/HER2-乳腺癌老年患者。主要终点是无进展生存期（PFS）。次要终点包括总生存期（OS）、安全性和耐受性，并考虑了肿瘤亚型、年龄、合并症及治疗细节等变量。 结果：中位PFS和OS略低于临床试验报告的数据，这反映了纳入人群的脆弱性更高。Luminal B亚型与较差的PFS相关，而年龄、BMI和ECOG状态等其他因素对结果无显著影响。安全性分析显示3级或以上毒性的发生率较高，尤其是在虚弱患者中，这导致了剂量减少。尽管存在这些挑战，CDK4/6抑制剂总体上耐受性良好，使大多数患者能够继续治疗。 结论：CDK4/6抑制剂联合内分泌疗法对老年转移性HR+/HER2-乳腺癌患者有效，但需谨慎管理以平衡疗效并减少不良事件。
肿瘤(癌症)患者之家