Patterns of treatment and outcomes of patients with metastatic HER2-low breast cancer treated with CDK4/6 inhibitors and hormone therapy.

Q2 Pharmacology, Toxicology and Pharmaceutics
Drugs in Context Pub Date : 2025-05-07 eCollection Date: 2025-01-01 DOI:10.7573/dic.2024-12-1
Federico Sottotetti, Barbara Tagliaferri, Gianpiero Rizzo, Raffaella Palumbo, Giulia Chessa, Chiara Raso, Lorenzo Perrone, Alberto Malovini, Valentina Tibollo, Laura Deborah Locati, Paolo Pedrazzoli, Angioletta Lasagna
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引用次数: 0

Abstract

Background: The 2018 American Society of Clinical Oncology/College of American Pathologists guidelines classified immunohistochemistry (IHC) 1+ or 2+, FISH-negative breast cancer as HER2-low. To date, only a few studies have investigated the role of HER2-low status in patients with hormone receptor positive/HER2- (HR+/HER2-) metastatic breast cancer (MBC) during CDK4/6 inhibitor (CDK4/6i) therapy.

Methods: This is a multicentre, retrospective cohort study analysing data from patients with HR+/HER2-low and HR+/HER2-0 MBC treated with CDK4/6i as first-line or second-line therapy at the Oncology Units of IRCCS San Matteo Hospital and ICS Maugeri IRCCS in Pavia, Italy, from January 2017 to October 2023. The aim was to assess the activity and effectiveness of CDK4/6i in a real-life setting.

Results: Of the 241 patients included, 240 (99.6%) were women. The median age at diagnosis was 57 years (IQR 48-65 years). Most patients had pM M0 (70.5%). At presentation, 112 (46.5%) had HER2-low and 129 (53.5%) had HER2-0 status. CDK4/6i were administered as first-line therapy in 89.2% of patients and as second-line therapy in 10.8% of patients, with palbociclib (61.4%) being the most common. The median progression-free survival during CDK4/6i therapy was 36.3 months (95% CI 23.6 months to not reached), while the median overall survival was 60.5 months (95% CI 54.4 months to not reached). Progression-free survival differed significantly between palbociclib and abemaciclib/ribociclib (24.4 versus 53.7 months; p=0.0109) and between first-line and second-line therapy (40.5 versus 21.2 months; p=0.0466).

Conclusion: CDK4/6i are effective in both HER2-low and HER2-0 MBC, with HER2-low potentially benefiting more from first-line therapy.

CDK4/6抑制剂和激素疗法治疗转移性her2低乳腺癌患者的治疗模式和结果
背景:2018年美国临床肿瘤学会/美国病理学家学会指南将免疫组织化学(IHC) 1+或2+,fish阴性乳腺癌分类为her2低。迄今为止,只有少数研究调查了HER2低状态在CDK4/6抑制剂(CDK4/6i)治疗期间激素受体阳性/HER2- (HR+/HER2-)转移性乳腺癌(MBC)患者中的作用。方法:这是一项多中心、回顾性队列研究,分析了2017年1月至2023年10月在意大利帕维亚的IRCCS圣马泰奥医院和ICS Maugeri IRCCS肿瘤部门接受CDK4/6i作为一线或二线治疗的HR+/HER2-low和HR+/HER2-0 MBC患者的数据。目的是评估CDK4/6i在现实生活中的活性和有效性。结果:纳入的241例患者中,女性240例(99.6%)。诊断时的中位年龄为57岁(IQR 48-65岁)。大多数患者pM M0(70.5%)。入院时,112例(46.5%)her2低,129例(53.5%)HER2-0状态。CDK4/6i在89.2%的患者中作为一线治疗,在10.8%的患者中作为二线治疗,帕博西尼(61.4%)是最常见的。CDK4/6i治疗期间的中位无进展生存期为36.3个月(95% CI为23.6个月至未达到),而中位总生存期为60.5个月(95% CI为54.4个月至未达到)。palbociclib和abemaciclib/ribociclib的无进展生存期差异显著(24.4个月vs 53.7个月;P =0.0109),一线和二线治疗之间的差异(40.5个月vs 21.2个月;p = 0.0466)。结论:CDK4/6i对her2 -低和HER2-0型MBC均有效,her2 -低可能从一线治疗中获益更多。
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来源期刊
Drugs in Context
Drugs in Context Medicine-Medicine (all)
CiteScore
5.90
自引率
0.00%
发文量
63
审稿时长
9 weeks
期刊介绍: Covers all phases of original research: laboratory, animal and human/clinical studies, health economics and outcomes research, and postmarketing studies. Original research that shows positive or negative results are welcomed. Invited review articles may cover single-drug reviews, drug class reviews, latest advances in drug therapy, therapeutic-area reviews, place-in-therapy reviews, new pathways and classes of drugs. In addition, systematic reviews and meta-analyses are welcomed and may be published as original research if performed per accepted guidelines. Editorials of key topics and issues in drugs and therapeutics are welcomed. The Editor-in-Chief will also consider manuscripts of interest in areas such as technologies that support diagnosis, assessment and treatment. EQUATOR Network reporting guidelines should be followed for each article type. GPP3 Guidelines should be followed for any industry-sponsored manuscripts. Other Editorial sections may include Editorial, Case Report, Conference Report, Letter-to-the-Editor, Educational Section.
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