CDK4/6抑制剂跨线治疗的临床获益和安全性概况:一项针对HR+/HER2-晚期乳腺癌的回顾性研究。

IF 5.6 2区 医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Qi Zhao, Mingxia Jiang, Jiaxuan Liu, Mengqi Zhang, Maiyue He, Shihan Zhou, Jiani Wang, Hongnan Mo, Bo Lan, Peng Yuan, Pin Zhang, Fei Ma, Qiao Li, Binghe Xu
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引用次数: 0

摘要

目的:CDK4/6抑制剂(CDK4/6is)与内分泌疗法相结合,在激素受体(HR)阳性晚期乳腺癌(ABC)的治疗中发挥了核心作用,并改变了治疗格局。跨线CDK4/6i疗法是指在前一种CDK4/6i治疗进展后,继续使用另一种CDK4/6i,这种疗法可能仍会提供有利的治疗效果。跨线CDK4/6i疗法是目前为改善HR+/人表皮生长因子受体2(HER2)-ABC患者治疗效果而积极研究的一个领域:这项回顾性研究纳入了82例HR+/HER2- ABC患者,他们在接受另一种CDK4/6i治疗后,接受了跨线CDK4/6i(abemaciclib、palbociclib、ribociclib和dalpiciclib)治疗。根据《实体瘤反应评估标准》1.1 版,主要终点是无进展生存期(PFS)。次要终点包括毒性、客观反应率、疾病控制率和总生存期。不良事件(AE)根据美国卫生与公众服务部颁布的《不良事件通用术语标准》5.0版进行分级:82名HR+/HER2- ABC患者在2022年1月至2024年2月期间接受了CDK4/6i的跨线治疗。患者的中位年龄为60岁。所有患者的中位PFS为7.6个月(95% CI,5.9-9.2)。Cox回归分析发现,肺转移和之前接受CDK4/6i治疗后转为内分泌治疗是预测PFS的独立因素。值得注意的是,既往接受过阿柏西尼(abemaciclib)治疗并在疾病进展后改用帕博西尼(palbociclib)治疗的患者的中位 PFS 为 10.7 个月。在之前接受CDK4/6i治疗的患者病情进展后过渡到化疗,然后再接受后续CDK4/6i治疗的策略值得进一步研究。血液学毒性是最常见的≥3级AEs。没有观察到致命的安全事件:在HR+/HER2- ABC患者中,跨线CDK4/6i治疗具有显著的临床获益和可控的安全性,这凸显了跨线CDK4/6i治疗作为一种有效治疗策略的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical benefit and safety profile of cross-line therapy with CDK4/6 inhibitors: a retrospective study of HR+/HER2- advanced breast cancer.

Objective: CDK4/6 inhibitors (CDK4/6is) in combination with endocrine therapy have secured a central role in the treatment of hormone receptor (HR)-positive advanced breast cancer (ABC) and have transformed the therapeutic landscape. Cross-line CDK4/6i therapy in which another CDK4/6i is continued after progression on a prior CDK4/6i may still offer advantageous therapeutic effects. Cross-line CDK4/6i therapy is an area of active investigation in the ongoing pursuit to improve outcomes for patients with HR+/human epidermal growth factor receptor 2 (HER2)- ABC.

Methods: This retrospective study enrolled 82 patients with HR+/HER2- ABC who were treated with cross-line CDK4/6is (abemaciclib, palbociclib, ribociclib, and dalpiciclib) after progression with another CDK4/6i. The primary endpoint was progression-free survival (PFS) according to version 1.1 of the Response Evaluation Criteria in Solid Tumors. Secondary endpoints included toxicity, objective response rate, disease control rate, and overall survival. Adverse events (AEs) were graded according to version 5.0 of the Common Terminology Criteria for Adverse Events, as promulgated by the U.S. Department of Health and Human Services.

Results: Eighty-two HR+/HER2- ABC patients who received cross-line CDK4/6i therapy from January 2022 to February 2024 were enrolled. The median age of the patients was 60 years. The median PFS of all patients was 7.6 months (95% CI, 5.9-9.2). Cox regression analysis identified lung metastasis and a switch to endocrine therapy following prior CDK4/6i therapy as independent predictive factors for PFS. Notably, patients who previously received abemaciclib and switched to palbociclib upon disease progression had a median PFS of 10.7 months. The strategy of transitioning to chemotherapy after progression on a prior CDK4/6i, then to a subsequent CDK4/6i merits further investigation. Hematologic toxicity was the most common grade ≥ 3 AEs. No instances of fatal safety events were observed.

Conclusions: Cross-line CDK4/6i therapy is associated with significant clinical benefits and manageable safety profiles in patients with HR+/HER2- ABC, which underscores cross-line CDK4/6i therapy potential as an effective treatment strategy.

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来源期刊
Cancer Biology & Medicine
Cancer Biology & Medicine Medicine-Oncology
CiteScore
9.80
自引率
3.60%
发文量
1143
审稿时长
12 weeks
期刊介绍: Cancer Biology & Medicine (ISSN 2095-3941) is a peer-reviewed open-access journal of Chinese Anti-cancer Association (CACA), which is the leading professional society of oncology in China. The journal quarterly provides innovative and significant information on biological basis of cancer, cancer microenvironment, translational cancer research, and all aspects of clinical cancer research. The journal also publishes significant perspectives on indigenous cancer types in China.
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