2024年度晚期乳腺癌共识与争议的现状及展望  

Current status and future perspectives on consensus and controversies in advanced breast cancer for 2024

作　　者：王小波 王涛 WANG Xiaobo;WANG Tao(Department of Medical Oncology,The Fifth Medical Center,Chinese PLA General Hospital,Beijing 100071,China)

机构地区：[1]中国人民解放军总医院第五医学中心肿瘤内科,北京100071

出　　处：《中国癌症杂志》2025年第3期263-272,共10页China Oncology

基　　金：北京市自然科学基金面上项目(7232161);首都卫生发展科研专项项目(首发2024-2-5064)。

摘　　要：乳腺癌是女性发病率最高的恶性肿瘤,晚期乳腺癌患者的5年生存率不足20%。随着对乳腺癌发生、发展机制认识的深入,以及越来越多新药、新方案的问世,晚期乳腺癌患者的生存期不断延长。晚期乳腺癌的治疗进展推动了治疗共识的形成,但与此同时新的争议也在不断发生。本文基于2024年度关键临床研究证据,系统性梳理当前不同分子分型乳腺癌治疗的共识与争议,旨在为临床实践提供更全面的循证医学依据。针对人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性晚期乳腺癌的一线治疗方案选择,尽管已经有CLEOPATRA研究结果使曲妥珠单抗和帕妥珠单抗联合紫杉类药物的治疗方案成为共识,但是PHILA研究结果提供了曲妥珠单抗和吡咯替尼联合紫杉类药物的新选择。两个研究亚组分析结果也为临床实践的差异化选择提供了参考。在晚期三阴性乳腺癌(triple-negative breast cancer,TNBC)的治疗中,对于程序性死亡蛋白配体-1(programmed death ligand-1,PD-L1)阳性患者,基于KEYNOTE-355、TORCHLIGHT研究,化疗联合程序性死亡蛋白-1(programmed death-1,PD-1)抑制剂治疗已成为标准推荐。然而,免疫治疗的选择人群、PD-L1阳性标准及免疫治疗药物的对应选择仍存在争议。新的抗体药物偶联物(antibody-drug conjugate,ADC)联合PD-L1抑制剂治疗的早期研究显示,不依赖于PD-L1表达,在晚期TNBC患者一线治疗中获得迄今最长的超过1年的无进展生存期(progression-free survival,PFS),可能是未来一线方案的最佳选择。激素受体阳性、HER2阴性晚期乳腺癌患者,细胞周期蛋白依赖性激酶(cyclin-dependent kinase,CDK)4/6抑制剂联合内分泌治疗已成为指南推荐的标准一线治疗。但SONIA研究设计对指南推荐和有效药物先用的传统治疗理念提出了挑战,SONIA研究结果提示并非所有的激素受体阳性、HER2阴性晚期乳腺癌一线治疗方�Breast cancer remains the most prevalent malignancy in women,with a 5-year survival rate less than 20%in advanced stages.The deepening understanding of breast cancer pathogenesis and the emergence of novel therapeutic agents/regimens have progressively extended survival outcomes for advanced breast cancer patients.While therapeutic advancements have driven the formation of treatment consensus,new controversies continue to emerge.This article systematically reviews current consensus and controversies in managing different molecular subtypes of breast cancer based on pivotal 2024 clinical evidence,aiming to provide evidence-based guidance for clinical practice.For first-line treatment of human epidermal growth factor receptor 2(HER2)-positive advanced breast cancer,the CLEOPATRA trial established the trastuzumab-pertuzumab-taxane regimen as standard care.However,the PHILA study proposed a new alternative combining trastuzumab,pyrotinib,and taxanes.Subgroup analyses from both trials provide valuable references for differentiated clinical decision-making.In triple-negative breast cancer(TNBC)management,KEYNOTE-355 and TORCHLIGHT trials established chemotherapy combined with programmed death-1(PD-1)inhibitors as standard therapy for programmed death ligand-1(PD-L1)-positive patients.Nevertheless,controversies persist regarding patient selection criteria,PD-L1 positivity thresholds,and optimal immunotherapy agents.Early-phase studies of antibody-drug conjugate(ADC)/PD-L1 inhibitor combinations demonstrated unprecedented progression-free survival(PFS)exceeding 12 months in the firstline TNBC treatment,independent of PD-L1 expression,potentially representing the future frontline regimen.For hormone receptorpositive/HER2-negative advanced breast cancer,cyclin-dependent kinase(CDK)4/6 inhibitor-endocrine therapy combinations remain guideline-endorsed first-line treatment.The SONIA trial challenged conventional paradigms by demonstrating that not all patients required upfront CDK4/6 inhibitors.It also highlighted critical u

关 键 词：晚期乳腺癌 共识 争议 

分 类 号：R737.9[医药卫生—肿瘤]