Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness.

IF 4.8 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2024-12-06 DOI:10.1093/oncolo/oyae273

Adam Brufsky, Xianchen Liu, Benjamin Li, Lynn McRoy, Connie Chen, Doris Makari, Rachel M Layman, Hope S Rugo

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引用次数: 0

Abstract

Background: Patients with cardiovascular disease (CVD) comorbidities are often excluded from participating in breast cancer clinical trials. Consequently, data to inform treatment decisions for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) and CVD are limited.

Objective: We compared the effectiveness of first-line palbociclib plus an aromatase inhibitor (AI) vs an AI alone and evaluated palbociclib treatment patterns in patients with HR+/HER2- mBC and CVD in routine clinical practice.

Methods: Data from the Flatiron Health Analytic Database were captured for patients with HR+/HER2- mBC and CVD who initiated first-line treatment with palbociclib plus an AI or an AI alone between February 2015 and March 2020 (data cutoff: September 30, 2020). Overall survival (OS), real-world progression-free survival (PFS), and treatment patterns were evaluated.

Results: Of the 469 patients with identifiable CVD, 160 received palbociclib plus an AI, and 309 received an AI alone. After stabilized inverse probability treatment weighting, both median OS (40.7 vs 26.5 months; hazard ratio [HR], 0.732 [95% CI, 0.537-0.997]; P = .048) and median real-world PFS (20.0 vs 12.5 months; HR, 0.679 [95% CI, 0.512-0.900]; P = .007) were significantly prolonged in patients treated with palbociclib plus an AI vs an AI alone. Among patients with a documented palbociclib starting dose, 78.5% started palbociclib at 125 mg/day, and 38.6% experienced dose adjustment.

Conclusions: In this real-world analysis, first-line palbociclib plus an AI was associated with improved effectiveness compared with an AI alone in patients with HR+/HER2- mBC and CVD.

Trial registration: NCT05361655 (ClinicalTrials.gov).

查看原文本刊更多论文

帕博西尼（Palbociclib）联合芳香化酶抑制剂治疗转移性乳腺癌和心血管疾病患者：实际效果。

背景：合并心血管疾病（CVD）的患者通常被排除在乳腺癌临床试验之外。因此，为激素受体阳性/人表皮生长因子受体 2 阴性（HR+/HER2-）转移性乳腺癌（mBC）和心血管疾病患者的治疗决策提供参考的数据非常有限：我们比较了一线帕博西尼（palbociclib）联合芳香化酶抑制剂（AI）与单独使用AI的疗效，并评估了常规临床实践中HR+/HER2- mBC和心血管疾病患者的帕博西尼治疗模式：从Flatiron健康分析数据库中获取了HR+/HER2- mBC和CVD患者的数据，这些患者在2015年2月至2020年3月期间（数据截止日期：2020年9月30日）开始接受palbociclib联合AI或单独AI的一线治疗。对总生存期（OS）、实际无进展生存期（PFS）和治疗模式进行了评估：结果：在469例可确定患有心血管疾病的患者中，160例接受了palbociclib加AI治疗，309例单独接受了AI治疗。经过稳定的逆概率治疗加权后，palbociclib联合AI与单用AI相比，中位OS（40.7个月 vs 26.5个月；危险比[HR]，0.732 [95% CI，0.537-0.997]；P = .048）和中位实际PFS（20.0个月 vs 12.5个月；HR，0.679 [95% CI，0.512-0.900]；P = .007）均显著延长。在有palbociclib起始剂量记录的患者中，78.5%的患者从125 mg/天开始服用palbociclib，38.6%的患者经历了剂量调整：在这项真实世界分析中，对于HR+/HER2- mBC和心血管疾病患者，一线palbociclib加一种AI比单独使用AI更有效：NCT05361655（ClinicalTrials.gov）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.