2024年度晚期乳腺癌共识与争议的现状及展望

王小波; 王涛

doi:10.19401/j.cnki.1007-3639.2025.03.002

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2024年度晚期乳腺癌共识与争议的现状及展望

专家述评 | 更新时间：2025-12-31

- 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
- 中国癌症杂志 2025年35卷第3期页码：263-272
- 作者机构：
  
  中国人民解放军总医院第五医学中心肿瘤内科，北京 100071
- 作者简介：
  
  [ "王小波（ORCID: 0009-0005-5097-1192），博士，主治医师。" ]
  [ "王涛，医学博士，主任医师，教授，博士研究生导师，中国人民解放军总医院第五医学中心肿瘤内科病区主任。中国临床肿瘤学会神经系统肿瘤专家委员会副主任委员，中国抗癌协会乳腺癌专业委员会常委，中国抗癌协会乳腺肿瘤整合康复专业委员会副主任委员，北京乳腺病防治学会副理事长，中国临床肿瘤学会乳腺癌专家委员会委员。曾于美国梅奥医学乳腺中心做访问学者。从事乳腺肿瘤诊治26年，擅长乳腺癌的综合治疗，包括化疗、内分泌治疗、靶向治疗。担任《中国临床肿瘤学会乳腺癌诊疗指南（2019—2024版）》《中国临床肿瘤学会神经系统肿瘤诊疗指南》的执笔者，同时是《中国晚期乳腺癌临床诊疗专家共识》《中国晚期乳腺癌维持治疗专家共识》等国内主要乳腺癌诊治相关指南与共识的专家组成员。先后承担国家自然科学基金、北京市自然科学基金、军队和北京市科委专项基金10余项。署名发表文章超过50篇，其中在SCI收录期刊上发表10余篇，主编、副主编、参编专著10部。" ]
- 基金信息：
  
  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(2024-2-5064)
- DOI：10.19401/j.cnki.1007-3639.2025.03.002
  中图分类号： R737.9
- 收稿：2025-01-02，
  
  修回：2025-02-20，
  
  纸质出版：2025-03-30
- 稿件说明：
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王小波, 王涛. 2024年度晚期乳腺癌共识与争议的现状及展望[J]. 中国癌症杂志, 2025,35(3):263-272.

Xiaobo WANG, Tao WANG. Current status and future perspectives on consensus and controversies in advanced breast cancer for 2024[J]. China Oncology, 2025, 35(3): 263-272.
王小波, 王涛. 2024年度晚期乳腺癌共识与争议的现状及展望[J]. 中国癌症杂志, 2025,35(3):263-272. DOI： 10.19401/j.cnki.1007-3639.2025.03.002.

Xiaobo WANG, Tao WANG. Current status and future perspectives on consensus and controversies in advanced breast cancer for 2024[J]. China Oncology, 2025, 35(3): 263-272. DOI： 10.19401/j.cnki.1007-3639.2025.03.002.

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案都应该选择CDK4/6抑制剂，同时SONIA研究的局限性也猝然显现，即CDK4/6抑制剂治疗失败后的治疗选择目前还无标准推荐，但基于现有循证医学证据建议有靶点突变优选靶点药物治疗，若无靶点突变可选择ADC药物、内分泌治疗等。脑转移是临床治疗的难点，随着更多的药物包括靶向HER2的小分子酪氨酸激酶抑制剂（tyrosine kinase inhibitor，TKI）药物和大分子ADC药物被证实对HER2阳性脑转移治疗有效，如何将药物治疗与局部治疗进行有机地结合，是需要深入研究的焦点。ADC药物是目前研发的热点领域，随着ADC药物越来越多，如何选择是目前临床研究的重点。未来的研究需要关注创新药物研发、整合各种治疗手段，给予患者精准个体化治疗，延长患者的生存期。

Abstract

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 first-line TNBC treatment

independent of PD-L1 expression

potentially representing the future frontline regimen. For hormone receptor-positive/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 unresolved issues: no standard recommendations exist for post-CDK4/6 inhibitor therapy

though current evidence supports prioritizing targeted therapies for mutation-positive cases or ADC/endocrine therapies for mutation-negative scenarios. Brain metastasis management presents ongoing challenges. Emerging anti-HER2 agents

including tyrosine kinase inhibitor (TKI) and ADC with demonstrated intracranial efficacy

necessitate further investigation into optimal integration strategies with local therapies. ADC dominate therapeutic innovation

with current research prioritizing optimal sequencing strategies amidst expanding ADC options. Future directions should focus on novel drug development

multimodal treatment integration

and personalized precision therapies to prolong patient survival.

关键词

Keywords

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