Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28).

IF 4.3 2区 医学 Q2 ONCOLOGY Therapeutic Advances in Medical Oncology Pub Date : 2024-12-17 eCollection Date: 2024-01-01 DOI:10.1177/17588359241302018
Yifan Chen, Yizhao Xie, Die Sang, Ning Xie, Xinhua Han, Yanxia Zhao, Juanjuan Li, Jian Yue, Peng Yuan, Biyun Wang
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Abstract

Background: In recent years, the combination of CDK4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) has emerged as the standard first-line treatment for hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) patients. However, the comparison between the efficacy of CDK4/6i has been poorly explored before. Moreover, it remains unclear about the optimal choice of CDK4/6i in the first-line treatment for HR+/HER2- MBC patients in Asian, especially Chinese populations.

Objectives: Our study aims to compare the efficacy of three CDK4/6i widely used in the Chinese population (palbociclib, abemaciclib, and dalpiciclib) in the real world.

Design: From 2020 to 2023, the medical records of patients diagnosed with HR+/HER2- MBC were retrospectively assessed in seven institutions in China. Patients who received first-line palbociclib, abemaciclib, or dalpiciclib plus ET were included.

Methods: Demographic and clinical data were retrospectively collected and analyzed. Real-world progression-free survival (rwPFS), overall survival (OS), and objective response rate were used to analyze the clinical outcome.

Results: In total, 209 HR+/HER2- MBC patients were eligible for this study. Eighty-eight (42.1%), 79 (37.8%), and 42 (20.1%) patients were administered first-line palbociclib, abemaciclib, or dalpiciclib plus ET. The overall median rwPFS was 19 months, with no significant difference between these three CDK4/6i (p = 0.84). The results were similar even after propensity score matching. The median OS was not reached. Cox univariate and multivariate regression analysis identified that higher KI67 index, liver metastasis, and primary endocrine resistance were independent risk factors for rwPFS in patients with initial CDK4/6i plus ET.

Conclusion: This study presents a comparison of the real-world efficacy between three CDK4/6i widely used in the Chinese population. Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC.

Trial registration: ClinicalTrials.gov identifier: NCT06344780.

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palbociclib, abemaciclib和dalpiciclib作为中国HR+/ her2转移性乳腺癌患者一线治疗的现实世界比较:一项多中心研究(YOUNGBC-28)。
背景:近年来,CDK4/6抑制剂(CDK4/6i)联合内分泌治疗(ET)已成为激素受体阳性(HR+)和人表皮生长因子受体2阴性(HER2-)转移性乳腺癌(MBC)患者的标准一线治疗方案。然而,之前对CDK4/6i的疗效进行比较的研究很少。此外,目前尚不清楚CDK4/6i在亚洲,特别是中国人群中HR+/HER2- MBC患者一线治疗中的最佳选择。目的:本研究旨在比较中国人群中广泛使用的三种CDK4/6i (palbociclib, abemaciclib和dalpiciclib)在现实世界中的疗效。设计:从2020年到2023年,回顾性评估中国7家机构诊断为HR+/HER2- MBC患者的病历。包括一线接受帕博西尼、阿贝马西尼或达匹西尼加ET治疗的患者。方法:回顾性收集人口学资料和临床资料进行分析。使用真实世界无进展生存期(rwPFS)、总生存期(OS)和客观缓解率来分析临床结果。结果:共有209例HR+/HER2- MBC患者符合本研究的条件。88例(42.1%)、79例(37.8%)和42例(20.1%)患者接受一线帕博西尼、阿贝马西尼或达匹西尼加ET治疗。总体中位rwPFS为19个月,这三种CDK4/6i之间无显著差异(p = 0.84)。即使在倾向得分匹配之后,结果也是相似的。未达到中位操作系统。Cox单因素和多因素回归分析发现,较高的KI67指数、肝转移和原发性内分泌抵抗是初始CDK4/6i合并et患者发生rwPFS的独立危险因素。结论:本研究比较了中国人群中广泛使用的三种CDK4/6i的实际疗效。Palbociclib、abemaciclib和dalpiciclib在中国晚期HR+/HER2- MBC患者中显示出相当的疗效。试验注册:ClinicalTrials.gov标识符:NCT06344780。
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
CiteScore
8.20
自引率
2.00%
发文量
160
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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