帕博西尼治疗HR+/HER2−晚期或转移性乳腺癌和内脏转移患者：系统文献综述

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2025-08-28 DOI:10.1016/j.breast.2025.104569

Julia C. Radosa , Sara López-Tarruella Cobo , Johanna Dzieran , Esther Glastetter , Connie Chen , Melissa Lingohr-Smith , Vinay Pasupuleti , Adam Brufsky

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引用次数: 0

摘要

背景：内脏转移在晚期/转移性乳腺癌（ABC）患者中很普遍，是生存率差的预后指标。我们对palbociclib联合内分泌治疗（ET）治疗激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2−）ABC和内脏转移患者的证据进行了系统的文献回顾。方法检索到2023年9月的spubmed、EMBASE、Cochrane Library及相关会议论文集。纳入了评估帕博西尼加ET的疗效/有效性、安全性和健康相关生活质量（QoL）的2/3期随机临床试验（rct）和真实世界证据（RWE）研究。结果对70篇文献进行了定性综合；来自8个随机对照试验的24个报告结果；46例为RWE研究。数据来自10000例接受帕博西尼治疗的内脏转移患者。在HR+/HER2 - ABC和内脏转移患者中评估帕博西尼加ET与单独ET的所有rct和RWE研究（各5项）显示，帕博西尼加ET可显著降低疾病进展和/或死亡风险（rct降低34% - 50%；RWE研究降低31% - 47%）。在随机对照试验中，两组患者的总生存率无显著差异；然而，5项RWE研究中有4项显示帕博西尼加ET有显著的益处（死亡风险降低36% - 42%）。尽管其他结果的数据有限，但帕博西尼加ET总体上是安全的，耐受性良好，同时维持了生活质量。结论rct和RWE研究一致表明，帕博西尼加ET治疗HR+/HER2−ABC合并内脏转移患者有效；该患者组的安全性、耐受性和生活质量有待进一步研究。

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Palbociclib treatment in patients with HR+/HER2− advanced or metastatic breast cancer and visceral metastasis: A systematic literature review

Background

Visceral metastasis is prevalent among patients with advanced/metastatic breast cancer (ABC) and is a prognostic indicator of poor survival. We conducted a systematic literature review of the evidence for palbociclib plus endocrine therapy (ET) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) ABC and visceral metastasis.

Methods

PubMed, EMBASE, Cochrane Library, and relevant conference proceedings were searched through September 2023. Phase 2/3 randomized clinical trials (RCTs) and real-world evidence (RWE) studies evaluating efficacy/effectiveness, safety, and health-related quality-of-life (QoL) of palbociclib plus ET were included.

Results

Qualitative synthesis was conducted on 70 articles; 24 reported results from 8 RCTs; 46 were RWE studies. Data from >10,000 patients with visceral metastasis treated with palbociclib were included. All RCTs and RWE studies (5 each) that assessed palbociclib plus ET versus ET alone in patients with HR+/HER2− ABC and visceral metastasis showed significant reduction in risk of disease progression and/or death with palbociclib plus ET (34 %–50 % reduction in RCTs; 31 %–47 % in RWE studies). In RCTs, overall survival was not significantly different between the treatment groups; however, 4 of 5 RWE studies showed a significant benefit (36 %–42 % reduced risk of death) with palbociclib plus ET. Although data for other outcomes were limited, palbociclib plus ET was generally safe and well tolerated while QoL was maintained.

Conclusion

Both RCTs and RWE studies consistently showed that palbociclib plus ET is efficacious/effective in patients with HR+/HER2− ABC and visceral metastasis; further research is warranted focused on safety, tolerability, and QoL in this patient group.

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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.