抗体药物偶联物在乳腺癌领域的研究现状与展望

林佳琳; 王文娜; 徐兵河

doi:10.19401/j.cnki.1007-3639.2025.02.002

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抗体药物偶联物在乳腺癌领域的研究现状与展望

专家述评 | 更新时间：2025-12-31

- 抗体药物偶联物在乳腺癌领域的研究现状与展望
- Current status and future perspectives of antibody-drug conjugates in breast cancer therapy
- 中国癌症杂志 2025年35卷第2期页码：154-166
- 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内科，北京 100021
- 作者简介：
  
  [ "林佳琳（ORCID: 0000-0002-6976-2172），博士研究生。" ]
  [ "徐兵河，博士，主任医师，教授，博士研究生及博士后导师，北京协和医学院长聘教授，中国工程院院士，中国医学科学院学部委员。现任中国医学科学院肿瘤医院国家抗肿瘤药物临床试验研究中心主任。徐兵河院士是国际乳腺癌诊疗领域的知名专家与领先学者，他在肿瘤内科治疗、乳腺癌的临床和转化研究领域中做出了开拓性贡献，取得了一系列具有国际影响力的系统性原创成果，改变了乳腺癌临床实践。同时在国际上也享有盛誉，担任St. Gallen早期乳腺癌治疗国际专家共识团成员、晚期乳腺癌治疗国际专家共识指南团成员、欧洲肿瘤内科学会（European Society for Medical Oncology，ESMO）和欧洲肿瘤学院（European School of Oncology，ESCO）核心成员（Faculty member）、ESMO早期乳腺癌临床实践指南执笔组成员，并担任 Lancet Oncology杂志国际顾问委员会委员。主持国家863科技专项、国家重点研发计划、国家自然科学基金重大专项等重大课题30余项；主编专著及高校教材15部；主持制定国家卫健委、国家癌症中心《乳腺癌诊疗指南》《乳腺癌合理用药指南》《中国乳腺癌筛查与早诊早治规范》等指南、规范和共识30余部；发表论文450余篇，其中在BMJ、Nature Medicine、Cancer Cell、Lancet Oncology、Annals of Oncology、Journal of Clinical Oncology、JAMA Oncology、STTT等国际著名期刊发表SCI论文260余篇。以第一完成人获国家科技进步二等奖、何梁何利基金科技进步奖、全国创新争先奖（基础研究与前沿探索）；另获省部级科技进步一等奖6项、二等奖4项以及国家发明授权专利10项；获首届“北京市先进科技工作者”、“首都十大健康卫士”、“北京市优秀研究生导师”、“北京市师德先锋”等荣誉称号。" ]
- 基金信息：
  
  中国医学科学院医学与健康科技创新工程研究项目(2021-12M-1-014);中国医学科学院医学与健康科技创新工程研究项目(2022-12M-2-002)
- DOI：10.19401/j.cnki.1007-3639.2025.02.002
  中图分类号： R737.9
- 收稿：2024-12-29，
  
  修回：2025-02-11，
  
  纸质出版：2025-02-28
- 稿件说明：
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林佳琳, 王文娜, 徐兵河. 抗体药物偶联物在乳腺癌领域的研究现状与展望[J]. 中国癌症杂志, 2025,35(2):154-166.

Jialin LIN, Wenna WANG, Binghe XU. Current status and future perspectives of antibody-drug conjugates in breast cancer therapy[J]. China Oncology, 2025, 35(2): 154-166.
林佳琳, 王文娜, 徐兵河. 抗体药物偶联物在乳腺癌领域的研究现状与展望[J]. 中国癌症杂志, 2025,35(2):154-166. DOI： 10.19401/j.cnki.1007-3639.2025.02.002.

Jialin LIN, Wenna WANG, Binghe XU. Current status and future perspectives of antibody-drug conjugates in breast cancer therapy[J]. China Oncology, 2025, 35(2): 154-166. DOI： 10.19401/j.cnki.1007-3639.2025.02.002.

摘要

抗体药物偶联物（antibody-drug conjugate，ADC）作为乳腺癌精准治疗的突破性药物，其独特的靶向递送机制能够有效地提高抗肿瘤治疗的选择性，并降低传统化疗的非特异性毒性。近年来，ADC在乳腺癌治疗中的应用范围不断拓展，尤其是在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性及HER2低表达乳腺癌中的成功应用，显著改变了疾病的治疗格局。其中，恩美曲妥珠单抗（trastuzumab emtansine，T-DM1）是首个取代拉帕替尼+卡培他滨方案，成为HER2阳性乳腺癌二线治疗的ADC类药，而德曲妥珠单抗（trastuzumab deruxtecan，DS-8201，T-DXd）在DESTINY-Breast04研究中展现出对HER2低表达乳腺癌的显著疗效，并成为首个获批用于该亚型患者的ADC。针对滋养层细胞表面抗原2（trophoblast cell surface antigen 2，Trop-2）靶点的ADC如戈沙妥珠单抗（sacituzumab govitecan，SG）也已在三阴性乳腺癌（triple-negative advanced breast cancer，TNBC）及激素受体阳性/HER2阴性乳腺癌患者中展现出良好的临床获益。此外，新一代ADC技术的优化，如提高连接子稳定性、优化药物抗体比（drug-to-antibody ratio，DAR）及增强旁观者效应，进一步提升了药物的抗肿瘤活性及安全性，使其成为乳腺癌精准治疗的重要发展方向。虽然ADC药物在提高疗效的同时仍可能伴随一定的靶点相关及载荷相关的不良反应，但随着管理策略的不断优化，其安全性已得到有效提升。HER2靶向ADC的不良反应主要包括T-DXd相关的间质性肺病（interstitial lung disease，ILD）、T-DM1的血小板减少及肝功能异常，而Trop-2靶向ADC如SG的血液毒性及胃肠道反应亦需关注。值得注意的是，新一代ADC在结构优化后已显著改善其安全性，并且通过早期监测、个体化剂量调整及支持治疗，可以有效地降低严重不良事件的发生风险。临床上ADC治疗的毒性管理已趋向成熟，绝大多数不良反应均可通过优化治疗方案和联合支持治疗得到有效控制。因此，在实际临床操作中，应综合考虑患者的个体因素、既往治疗史及伴随疾病情况，以制定最优的ADC应用策略，确保疗效与安全性的最大化。随着ADC技术的不断进步，未来乳腺癌治疗将更加精准化。新型HER2-Trop-2双靶点ADC的研发为HER2低表达及HER2阴性乳腺癌患者提供了新的治疗可能，而T-DXd联合免疫检查点抑制剂（immune checkpoint inhibitor，ICI）、CDK4/6抑制剂及多腺苷二磷酸核糖聚合酶[poly（ADP-ribose）polymerase，PARP]抑制剂的研究显示出协同抗肿瘤效应。本综述系统总结乳腺癌ADC的最新研究进展，重点探讨HER2及Trop-2靶向ADC的临床应用、安全性管理策略及新型ADC的发展趋势，旨在为乳腺癌的精准治疗提供参考。

Abstract

Antibody-drug conjugates (ADCs) represent a breakthrough in precision therapy for breast cancer

offering a unique targeted drug delivery mechanism that enhances tumor selectivity while reducing the nonspecific toxicity associated with conventional chemotherapy. In recent years

the clinical applications of ADCs in breast cancer have expanded significantly

particularly in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low breast cancer

reshaping the therapeutic landscape. Trastuzumab emtanserin (T-DM1) was the first ADC drug to replace lapatinib plus capecitabine as a second-line treatment for HER2-positive breast cancer

while trastuzumab deruxtecan (T-DXd) demonstrated remarkable efficacy in HER2-low breast cancer in the DESTINY-Breast04 trial

becoming the first approved ADC for this patient subgroup. Furthermore

trophoblast cell surface antigen 2 (Trop-2)-targeting ADCs

such as sacituzumab govitecan (SG)

have shown promising clinical benefits in patients with triple-negative breast cancer (TNBC) and hormone receptor-positive/HER2-negative breast cancer. Advances in next-generation ADC technologies

including improvements in linker stability

drug-to-antibody ratio (DAR) optimization

and enhanced bystander effects

have further improved the therapeutic efficacy and safety profile of these agents

reinforcing their role in the precision treatment of breast cancer. Although ADCs have demonstrated substantial clinical benefits

they are associated with target- and payload-related toxicities. However

with ongoing advancements in management strategies

their safety profile has been significantly improved. HER2-targeting ADCs present specific adverse events

including interstitial lung disease (ILD) associated with T-DXd

thrombocytopenia

and liver function abnormalities observed with T-DM1

while Trop-2-targeting ADCs such as SG are linked to hematologic toxicity and gastrointestinal side effects. Notably

structural optimizations in next-generation ADCs have led to significant improvements in their safety profile. Early monitoring

individualized dose modifications

and supportive care measures have been shown to effectively reduce the incidence of severe adverse events. Clinical studies indicate that toxicity management strategies for ADCs have matured

with most adverse effects being effectively controlled through optimized treatment regimens and adjunctive supportive care. Thus

in clinical practice

it is essential to consider patient-specific factors

prior treatment history

and comorbidities to devise an optimal ADC treatment strategy that maximizes both efficacy and safety. As ADC technology continues to evolve

breast cancer treatment is expected to become increasingly precise. The development of novel HER2-Trop-2 bispecific ADCs offers new therapeutic options for patients with HER2-low and HER2-negative breast cancer. Additionally

studies investigating the combination of T-DXd with immune checkpoint inhibitors (ICIs)

CDK4/6 inhibitors

and poly (ADP-ribose) polymerase (PARP) inhibitors have demonstrated synergistic antitumor effects

further expanding the prospects for precision medicine in breast cancer. This review systematically summarized the latest advancements in ADCs for breast cancer

with a focus on the clinical applications

safety management strategies

and future development of HER2- and Trop-2-targeting ADCs

aiming to provide valuable insights for the future of precision breast cancer treatment.

关键词

Keywords

references

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