Background:Older adults aged ≥80 with HR+/HER2− metastatic breast cancer (MBC) are often underrepresented in clinical trials, leaving clinicians with limited data to guide treatment decisions. Given the increasing prevalence of this age group, real-world evidence is crucial to inform therapeutic strategies.Methods:We performed a multicenter retrospective study across seven Italian oncology units, focusing on patients aged 80 or above who received CDK4/6 inhibitors in combination with endocrine therapy between January 2020 and May 2024. Baseline characteristics, treatment details, and adverse events were recorded. Primary endpoints were progression-free survival (PFS) and overall survival (OS); toxicity was assessed using CTCAE v5.0. Follow-up was estimated using the reverse Kaplan–Meier method.Results:Eighty patients were included, with a median age of 83. Over half had visceral metastases, and 41.0% were frail (G8 ≤ 14). Approximately 44.0% of patients started treatment at a reduced dose. The median PFS was 13 months (95.0% CI 9.3–18.0), and the median OS was 15 months (95.0% CI 11.8–18.2). Hematologic toxicity was frequent, with neutropenia occurring in 58.8% (25.0% grade ≥ 3) and anemia in 12.5% (2.5% grade ≥ 3). Asthenia was reported in 16.2% (5.0% grade ≥ 3). Diarrhea occurred in 3.8% overall, mainly in patients treated with abemaciclib (42.9% any grade; 14.3% grade ≥ 3). ALT/AST elevations were observed in 8.8% (1.2% grade ≥ 3), and QTc prolongation in 2.5% (1.2% grade ≥ 3, all with ribociclib). Grade ≥ 3 events were uncommon and generally manageable.Conclusions:CDK4/6 inhibitor-based therapy is feasible in patients aged ≥80 years, with outcomes and tolerability comparable to those observed in younger elderly. Our results highlight the importance of individualized treatment strategies in this oldest-old population.
背景：年龄≥80岁、激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2−）转移性乳腺癌（MBC）的老年患者在临床试验中代表性常显不足，导致临床医生缺乏足够的治疗决策依据。随着该年龄段患者比例的增加，真实世界证据对于指导治疗策略至关重要。 方法：我们在意大利七家肿瘤中心开展了一项多中心回顾性研究，纳入2020年1月至2024年5月期间接受CDK4/6抑制剂联合内分泌治疗的80岁及以上患者。记录基线特征、治疗细节及不良事件。主要终点为无进展生存期（PFS）和总生存期（OS）；毒性评估采用CTCAE v5.0标准。随访时间通过逆卡普兰-迈耶法进行估算。 结果：共纳入80例患者，中位年龄83岁。超过半数患者存在内脏转移，41.0%为衰弱状态（G8评分≤14）。约44.0%的患者起始治疗时采用减量方案。中位PFS为13个月（95.0% CI 9.3–18.0），中位OS为15个月（95.0% CI 11.8–18.2）。血液学毒性较为常见，中性粒细胞减少发生率为58.8%（其中≥3级占25.0%），贫血发生率为12.5%（≥3级占2.5%）。乏力发生率为16.2%（≥3级占5.0%）。总体腹泻发生率为3.8%，主要见于接受阿贝西利治疗的患者（任何级别42.9%；≥3级14.3%）。ALT/AST升高发生率为8.8%（≥3级占1.2%），QTc延长发生率为2.5%（≥3级占1.2%，均发生于瑞博西利治疗者）。≥3级不良事件发生率较低且总体可控。 结论：基于CDK4/6抑制剂的治疗方案在≥80岁高龄患者中具有可行性，其疗效与耐受性与较年轻老年患者相当。本研究结果凸显了对这一超高龄人群实施个体化治疗策略的重要性。
肿瘤(癌症)患者之家