Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2− metastatic breast cancer: A Flatiron Health database analysis

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2025-03-17 DOI:10.1016/j.breast.2025.104448

Rachel M. Layman , Xianchen Liu , Benjamin Li , Lynn McRoy , Adam Brufsky

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引用次数: 0

Abstract

Purpose

To examine the associations of palbociclib dose modifications with clinical outcomes of patients with HR+/HER2− metastatic breast cancer (MBC) treated with first-line (1L) palbociclib + aromatase inhibitor (AI) in routine practice.

Methods

Using the Flatiron Health Analytic Database, we conducted a retrospective analysis of HR+/HER2− MBC patients who started 1L palbociclib + AI February 2015–March 2020. Kaplan−Meier analyses were used to estimate treatment duration, real-world progression-free survival (rwPFS), and overall survival (OS) by palbociclib dose adjustments (any change in palbociclib daily dose while on treatment) and dose reductions (starting dose <125 mg/day or dose reduced while on treatment). Cox proportional hazard regression models were performed to compute unadjusted/adjusted hazard ratios (HRs).

Results

Of 1302 patients with documented starting dose, 524 (40.2 %) had palbociclib dose adjustments; 778 (59.8 %) had none. Median treatment duration was significantly longer in patients with dose adjustments versus those with none (27.4 vs 21.4 months; adjusted HR = 0.80 [95 % CI, 0.69–0.93]; P = 0.004). Patients with and without dose adjustments showed similar median rwPFS (20.5 vs 19.6 months; adjusted HR = 0.89 [95 % CI, 0.76–1.04]; P = 0.133). Median OS was significantly prolonged in patients with versus without dose adjustments (57.8 vs 51.4 months; adjusted HR = 0.73 [95 % CI, 0.59–0.89]; P = 0.002). Similar findings were observed in patients with and without dose reductions.

Conclusions

In this real-world study, rwPFS in HR+/HER2− MBC patients was maintained irrespective of dose adjustments. However, dose adjustments were associated with extended treatment duration and OS.

Clinical trial registration

NCT05361655 (ClinicalTrials.gov)

查看原文本刊更多论文

现实世界HR+/HER2 -转移性乳腺癌患者的帕博西尼剂量调整和临床结果：Flatiron Health数据库分析

目的探讨帕博西尼剂量调整与常规一线（1L）帕博西尼+芳香酶抑制剂（AI）治疗HR+/HER2−转移性乳腺癌（MBC）患者临床结局的关系。方法利用Flatiron健康分析数据库，对2015年2月- 2020年3月开始使用1L帕博西尼+ AI的HR+/HER2 - MBC患者进行回顾性分析。Kaplan - Meier分析通过帕博西尼剂量调整（治疗期间帕博西尼每日剂量的任何变化）和剂量减少（起始剂量& 125 mg/天或治疗期间剂量减少）来估计治疗持续时间、真实无进展生存期（rwPFS）和总生存期（OS）。采用Cox比例风险回归模型计算未调整/调整风险比（hr）。结果1302例有起始剂量记录的患者中，524例（40.2%）进行了帕博西尼剂量调整；778例（59.8%）无。接受剂量调整的患者的中位治疗持续时间明显长于未接受剂量调整的患者(27.4个月vs 21.4个月；调整后的HR = 0.80 [95% CI, 0.69-0.93]；p = 0.004)。调整剂量和不调整剂量的患者显示出相似的中位rwPFS (20.5 vs 19.6个月；调整后的HR = 0.89 [95% CI, 0.76-1.04]；p = 0.133)。调整剂量组与未调整剂量组的中位生存期显著延长(57.8个月vs 51.4个月；调整后的HR = 0.73 [95% CI, 0.59-0.89]；p = 0.002)。在减量和不减量的患者中也观察到类似的结果。结论在现实世界的研究中，无论剂量调整如何，HR+/HER2 - MBC患者的rwPFS都保持不变。然而，剂量调整与延长治疗时间和生存期有关。临床试验注册nct05361655 （ClinicalTrials.gov）

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.