乳腺癌免疫检查点抑制剂治疗的研究进展与探索方向

曾成; 王沅怡; 王佳妮; 马飞

doi:10.19401/j.cnki.1007-3639.2025.02.006

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乳腺癌免疫检查点抑制剂治疗的研究进展与探索方向

专家述评 | 更新时间：2025-12-31

- 乳腺癌免疫检查点抑制剂治疗的研究进展与探索方向
- Advances in immune checkpoint inhibitor therapy for breast cancer: research progress and future directions
- 中国癌症杂志 2025年35卷第2期页码：195-204
- 作者机构：
  
  国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科，北京 100021
- 作者简介：
  
  [ "曾成（ORCID: 0000-0002-9392-8259），博士研究生。" ]
  [ "马飞，主任医师，教授，博士研究生导师，博士后合作导师，教育部长江学者特聘教授、北京协和医学院长聘教授、国家癌症中心/中国医学科学院肿瘤医院肿瘤内科治疗中心主任。任分子肿瘤学全国重点实验室PI、国家重点研发计划首席科学家、Cancer Innovation主编、健康中国研究中心癌症防治专委会主任委员、国家肿瘤质控中心乳腺癌专委会副主任委员兼秘书长、中国乳腺癌筛查与早诊早治规范委员会秘书长、国家抗肿瘤药物临床应用监测专委会秘书长、中国抗癌协会肿瘤药物临床研究专业委员会副主任委员、中国抗癌协会整合肿瘤心脏病学分会副主任委员、中国抗癌协会标准建设委员会秘书长、中国药师协会肿瘤专科药师分会副主任委员、中国抗癌协会多原发和不明原发肿瘤专业委员会副主任委员、博鳌肿瘤创新研究院理事长等职。主持国家科技重大专项、国家重点研发计划、国家自然科学基金重点项目等多项课题。研究成果发表于British Medical Journal、Nature Medicine、 Lancet Oncology、Cancer Cell、Signal Transduction and Targeted Therapy等国际著名学术期刊。获国家科技进步二等奖、中国抗癌协会科技奖一等奖、中国肿瘤青年科学家奖等。" ]
- 基金信息：
  
  国家自然科学基金重点项目(82230058)
- DOI：10.19401/j.cnki.1007-3639.2025.02.006
  中图分类号： R737.9
- 收稿：2024-12-23，
  
  修回：2025-02-03，
  
  纸质出版：2025-02-28
- 稿件说明：
移动端阅览
曾成, 王沅怡, 王佳妮, 等. 乳腺癌免疫检查点抑制剂治疗的研究进展与探索方向[J]. 中国癌症杂志, 2025,35(2):195-204.

Cheng ZENG, Yuanyi WANG, Jiani WANG, et al. Advances in immune checkpoint inhibitor therapy for breast cancer: research progress and future directions[J]. China Oncology, 2025, 35(2): 195-204.
曾成, 王沅怡, 王佳妮, 等. 乳腺癌免疫检查点抑制剂治疗的研究进展与探索方向[J]. 中国癌症杂志, 2025,35(2):195-204. DOI： 10.19401/j.cnki.1007-3639.2025.02.006.

Cheng ZENG, Yuanyi WANG, Jiani WANG, et al. Advances in immune checkpoint inhibitor therapy for breast cancer: research progress and future directions[J]. China Oncology, 2025, 35(2): 195-204. DOI： 10.19401/j.cnki.1007-3639.2025.02.006.

摘要

乳腺癌是全球女性中发病率最高的恶性肿瘤。近年来，免疫检查点抑制剂（immune checkpoint inhibitor，ICI）作为一种新兴的治疗策略，在乳腺癌的不同分子分型中展现出重要的临床应用价值。本综述系统地总结ICI在激素受体（hormone receptor，HR）阳性型、人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）过表达型及三阴型乳腺癌（triple-negative breast cancer，TNBC）中的研究进展及临床应用前景。其中，在HR阳性乳腺癌中，KEYNOTE-756和CheckMate 7FL研究证实，ICI联合新辅助化疗可提高病理学完全缓解（pathological complete response，pCR）率，其中程序性死亡受体配体1（programmed cell death-ligand 1，PD-L1）阳性患者获益更明显。此外，PROMENADE研究表明，雌激素受体（estrogen receptor，ER）、低表达HER2阴性乳腺癌患者接受ICI治疗后的pCR率更接近TNBC，而非HR阳性乳腺癌。在转移性HR阳性乳腺癌中，SACI-IO和DOLAF研究提示，ICI联合抗体药物偶联物（antibody-drug conjugate，ADC）或多腺苷二磷酸核糖聚合酶[poly (ADP-ribose) polymerase，PARP]抑制剂可能为特定亚组患者带来临床获益。在HER2过表达乳腺癌中，Keyriched-1和Neo-PATH研究显示，ICI联合抗HER2治疗可能改善HR阴性/HER2阳性患者的pCR情况。然而，Impassion-050和KATE2研究未能证明ICI使HER2阳性乳腺癌患者获益。在TNBC中，KEYNOTE-522研究的长期随访数据显示，新辅助ICI联合化疗不仅提高pCR率，还能为患者带来长期的生存获益。Impassion-130、KEYNOTE-355和TORCHLIGHT等研究证实，ICI联合化疗可改善PD-L1阳性晚期TNBC患者的无进展生存期（progression-free survival，PFS）和总生存期（overall survival，OS）。此外，ICI联合抗血管生成治疗、PARP抑制剂及ADC的治疗策略在TNBC中呈现出良好的应用前景。目前，ICI联合化疗仍是主要的治疗模式，同时ICI与抗HER2治疗、内分泌治疗、ADC及抗血管生成治疗的联合方案亦在积极探索中。然而，ICI治疗仍面临耐药机制复杂、疗效异质性及免疫相关不良事件管理等挑战。未来应进一步优化患者分层管理并探索更精准的联合治疗策略，以使乳腺癌患者的生存长期获益。

Abstract

Breast cancer is the most prevalent malignancy among women worldwide. In recent years

immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic strategy across different molecular subtypes of breast cancer

demonstrating significant clinical potential. This review systematically summarized the progress and clinical applications of ICIs in hormone receptor-positive (HR-positive)

human epidermal growth factor receptor 2-overexpressing (HER2-positive)

and triple-negative breast cancer (TNBC). In HR-positive breast cancer

the KEYNOTE-756 and CheckMate 7FL trials demonstrated that ICIs combined with neoadjuvant chemotherapy significantly improved the pathological complete response (pCR) rate

with greater benefits observed in programmed cell death-ligand 1 (PD-L1)-positive patients. Furthermore

the PROMENADE study indicated that estrogen receptor (ER)-low HER2-negative breast cancer patients achieved a pCR rate closer to that of TNBC rather than HR-positive breast cancer following ICIs treatment. In metastatic HR-positive breast cancer

the SACI-IO and DOLAF studies suggested that ICIs combined with antibody-drug conjugates (ADC) or poly (ADP-ribose) polymerase (PARP) inhibitors may provide clinical benefits for specific subgroups of patients. For HER2-positive breast cancer

the Keyriched-1 and Neo-PATH studies revealed that ICIs combined with anti-HER2 therapy might improve pCR rates in HR-negative/HER2-positive patients. However

the Impassion-050 and KATE2 trials failed to demonstrate widespread clinical benefits of ICIs in HER2-positive breast cancer. In TNBC

long-term follow-up data from the KEYNOTE-522 study showed that ICIs combined with neoadjuvant chemotherapy not only improved pCR rates but also conferred long-term survival benefits. Additionally

the Impassion-130

KEYNOTE-355

and TORCHLIGHT studies confirmed that ICIs combined with chemotherapy prolonged both progression-free survival (PFS) and overall survival (OS) in PD-L1-positive advanced TNBC patients. Meanwhile

treatment strategies combining ICIs with anti-angiogenic therapy

PARP inhibitors and ADCs have demonstrated promising efficacy in TNBC (SPARK and BEGONIA trial). Currently

ICIs combined with chemotherapy remains the primary treatment approach

while combination strategies involving ICIs with anti-HER2 therapy

endocrine therapy

ADCs

and anti-angiogenic therapy are actively being explored. However

challenges remain

including complex resistance mechanisms

heterogeneous treatment responses

and the management of immune-related adverse events. Future research should focus on refining patient stratification strategies and developing more precise combination therapies to improve long-term survival outcomes for breast cancer patients.

关键词

Keywords

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