Weston Park Hospital, Whitham Rd, Broomhall, Sheffield, S10 2SJ, UK.
Department of Oncology and Metabolism, The University of Sheffield, Beech Hill Road, Sheffield, S10 2SF, UK.
Breast. 2021 Dec;60:199-205. doi: 10.1016/j.breast.2021.10.010. Epub 2021 Oct 28.
Breast cancer incidence increases with age and real-world data is essential to guide prescribing practices in the older population. The aim of this study was to collect large scale real-world data on tolerability and efficacy of palbociclib + AI in the first line treatment of ER+/HER2-advanced breast cancer in those aged ≥75 years.
14 cancer centres participated in this national UK retrospective study. Patients aged ≥75 years treated with palbociclib + AI in the first line setting were identified. Data included baseline demographics, disease characteristics, toxicities, dose reductions and delays, treatment response and survival data. Multivariable Cox regression was used to assess independent predictors of PFS, OS and toxicities.
276 patients met the eligibility criteria. The incidence of febrile neutropenia was low (2.2%). The clinical benefit rate was 87%. 50.7% of patients had dose reductions and 59.3% had dose delays. The 12- and 24- month PFS rates were 75.9% and 64.9%, respectively. The 12- and 24- month OS rates were 85.1% and 74.0%, respectively. Multivariable analysis identified PS, Age-adjusted Charlson Comorbidity Index (ACCI) and number of metastatic sites to be independent predictors of PFS. Dose reductions and delays were not associated with adverse survival outcomes. Baseline ACCI was an independent predictor of development and severity of neutropenia.
Palbociclib is an effective therapy in the real-world older population and is well-tolerated with low levels of clinically significant toxicities. The use of geriatric and frailty assessments can help guide decision making in these patients.
乳腺癌的发病率随年龄增长而增加，真实世界的数据对于指导老年人群的处方实践至关重要。本研究旨在收集大量关于在≥75 岁人群中，用于一线治疗 ER+/HER2-晚期乳腺癌的哌柏西利联合 AI 的耐受性和疗效的真实世界数据。
14 家癌症中心参与了这项英国全国性回顾性研究。确定了年龄≥75 岁且接受一线哌柏西利联合 AI 治疗的患者。数据包括基线人口统计学、疾病特征、毒性、剂量减少和延迟、治疗反应和生存数据。多变量 Cox 回归用于评估 PFS、OS 和毒性的独立预测因素。
符合入选标准的患者共 276 例。发热性中性粒细胞减少症的发生率较低（2.2%）。临床获益率为 87%。50.7%的患者减少了剂量，59.3%的患者延迟了剂量。12 个月和 24 个月的 PFS 率分别为 75.9%和 64.9%。12 个月和 24 个月的 OS 率分别为 85.1%和 74.0%。多变量分析确定 PS、年龄调整 Charlson 合并症指数（ACCI）和转移性病灶数量是 PFS 的独立预测因素。剂量减少和延迟与不良生存结果无关。基线 ACCI 是中性粒细胞减少症发生和严重程度的独立预测因素。
哌柏西利在真实世界的老年人群中是一种有效的治疗方法，且耐受性良好，仅有少量临床意义重大的毒性。使用老年评估和虚弱评估可以帮助指导这些患者的决策。
