德曲妥珠单抗所致间质性肺病全程管理策略

张剑; 韩茜; 徐菲; 甘露; 陈占红; 马力; 王浩; 刘洁琼; 吴小红; 蔡莉; 赵兵; 吕铮; 黎莉; 倪苏婕; 胡夕春

doi:10.19401/j.cnki.1007-3639.2024.12.001

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德曲妥珠单抗所致间质性肺病全程管理策略

专家述评 | 更新时间：2025-12-31

- 德曲妥珠单抗所致间质性肺病全程管理策略
- Comprehensive management strategy of interstitial lung disease induced by trastuzumab deruxtecan
- 中国癌症杂志 2024年34卷第12期页码：1067-1079
- 作者机构：
  
  1. 复旦大学附属肿瘤医院肿瘤内科，复旦大学上海医学院肿瘤学系，上海 200032
  2. 上海市抗癌协会肿瘤药物临床研究专业委员会，上海 200032
  3. 广州医科大学附属第一医院，广州呼吸健康研究院，呼吸内科，广东广州 510120
  4. 中山大学肿瘤防治中心肿瘤内科，广东广州 510000
  5. 重庆医科大学附属第一医院肿瘤科，重庆 400042
  6. 浙江省肿瘤医院乳腺内科，浙江杭州 310022
  7. 河北医科大学第四医院乳腺中心，河北石家庄 050011
  8. 四川省肿瘤医院乳腺外科，四川成都 610041
  9. 中山大学孙逸仙纪念医院乳腺外科，广东广州 510120
  10. 江南大学附属医院肿瘤内科，江苏无锡 214122
  11. 哈尔滨医科大学附属肿瘤医院乳腺肿瘤内科，黑龙江哈尔滨 150081
  12. 新疆医科大学附属肿瘤医院乳腺内科，新疆乌鲁木齐 830011
  13. 吉林大学白求恩第一医院肿瘤科，吉林长春 130021
  14. 山东大学齐鲁医院肿瘤内科，山东济南 250012
  15. 南通大学附属医院肿瘤化疗科，江苏南通 226006
- 作者简介：
  
  [ "胡夕春，主任医师，教授，博士研究生导师，复旦大学附属肿瘤医院大内科首席专家，复旦大学附属肿瘤医院福建医院（福建省肿瘤医院）大内科主任。现为欧洲临床肿瘤学会（European Society for Medical Oncology，ESMO）乳腺癌Faculty Member、国际ABC5-7 Panelist、中华医学会肿瘤学分会肿瘤内科专家委员会副主任委员、中国抗癌协会多原发和不明原发肿瘤专业委员会荣誉主任委员、中国抗癌协会临床化疗专业委员会副主任委员、中国抗癌协会分子靶向专业委员会副主任委员、中国研究型医院学会乳腺专业委员会副主任委员、上海市医师协会肿瘤科医师分会副会长、上海市抗癌协会常务理事、上海市抗癌协会肿瘤药物临床研究专业委员会主任委员、上海市抗癌协会癌症康复和姑息治疗委员会前任主任委员、国家食品药品监督管理总局审评中心审评专家等。已在The Lancet Oncology、Journal of Clinical Oncology等杂志发表论著300多篇。主编《肿瘤内科方案的药物不良反应及对策》和《肿瘤科常见诊疗问题问答—胡夕春医师查房实录》等专著。主持十三五计划“重大新药创制”科技重大专项等，获上海市领军人才、中国抗癌协会科技奖二等奖、全国妇幼健康科学技术奖一等奖和上海市医学科技进步奖一等奖等。国际ABC5-7 Panelist、中华医学会肿瘤学分会肿瘤内科专家委员会副主任委员、中国抗癌协会多原发和不明原发肿瘤专业委员会荣誉主任委员、中国抗癌协会临床化疗专业委员会副主任委员、中国抗癌协会分子靶向专业委员会副主任委员、中国研究型医院学会乳腺专业委员会副主任委员、上海市医师协会肿瘤科医师分会副会长、上海市抗癌协会常务理事、上海市抗癌协会肿瘤药物临床研究专业委员会主任委员、上海市抗癌协会癌症康复和姑息治疗委员会前任主任委员、国家食品药品监督管理总局审评中心审评专家等。已在The Lancet Oncology、Journal of Clinical Oncology等杂志发表论著300多篇。主编《肿瘤内科方案的药物不良反应及对策》和《肿瘤科常见诊疗问题问答—胡夕春医师查房实录》等专著。主持十三五计划“重大新药创制”科技重大专项等，获上海市领军人才、中国抗癌协会科技奖二等奖、全国妇幼健康科学技术奖一等奖和上海市医学科技进步奖一等奖等。张剑（ORCID: 0009-0008-7807-3492），博士，主任医师，教授，博士研究生导师。" ]
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2024.12.001
  中图分类号：
- 收稿：2024-11-13，
  
  纸质出版：2024-12-30
- 稿件说明：
移动端阅览
张剑, 韩茜, 徐菲, 等. 德曲妥珠单抗所致间质性肺病全程管理策略[J]. 中国癌症杂志, 2024,34(12):1067-1079.

Jian ZHANG, Qian HAN, Fei XU, et al. Comprehensive management strategy of interstitial lung disease induced by trastuzumab deruxtecan[J]. China Oncology, 2024, 34(12): 1067-1079.
张剑, 韩茜, 徐菲, 等. 德曲妥珠单抗所致间质性肺病全程管理策略[J]. 中国癌症杂志, 2024,34(12):1067-1079. DOI： 10.19401/j.cnki.1007-3639.2024.12.001.

Jian ZHANG, Qian HAN, Fei XU, et al. Comprehensive management strategy of interstitial lung disease induced by trastuzumab deruxtecan[J]. China Oncology, 2024, 34(12): 1067-1079. DOI： 10.19401/j.cnki.1007-3639.2024.12.001.

摘要

德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）已在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）表达乳腺癌、胃癌、肺癌及其他实体瘤等领域的临床试验中证实了显著疗效，其安全性总体可控、可耐受，但其也会导致间质性肺病（interstitial lung disease，ILD）。ILD病因多样，不同抗肿瘤药物所致ILD发生率不等，症状表现各异，发病机制尚不明确。T-DXd相关ILD多为1~2级，实施规范化的临床管理措施可降低ILD严重事件的发生率，改善患者预后，有利于实现T-DXd临床获益最大化。本文对ILD的流行病学、病因、高危因素以及药物所致ILD的可能机制进行总结，并重点介绍T-DXd所致ILD的发生率、发生时间以及经规范化临床管理后的ILD发生情况，以帮助读者更好地理解T-DXd治疗前和治疗期间进行规范化临床管理的重要性。在具体的临床管理策略上，本文结合临床研究方案管理标准及国内外真实世界管理经验，从患者筛查、患者教育、ILD监测、诊断和治疗等方面对T-DXd所致ILD全程管理策略进行综述。在接受T-DXd治疗前，患者筛查有助于识别高危ILD风险患者，高危患者应谨慎使用T-DXd。

Abstract

Trastuzumab deruxtecan (T-DXd) has demonstrated significant efficacy in clinical trials for human epidermal growth factor receptor 2 (HER2)-expressing breast cancer

gastric cancer

lung cancer and other solid tumors. Its overall safety profile is manageable and tolerable

including the clinically concerning interstitial lung disease (ILD). The etiology of ILD is varied

among which drug-induced ILD is an exclusionary diagnosis. The incidence of ILD caused by different antitumor drugs varies with different symptoms

and the pathogenesis remains unclear. T-DXd-induced ILD is mostly Grades 1-2

and implementing a standardized clinical management protocol can reduce the incidence of severe ILD events

improve patient prognosis

and help maximize the clinical benefits of T-DXd. This article summarized the epidemiology

etiology

risk factors

and potential mechanisms of drug-induced ILD

with a focus on the incidence

time to onset

and outcomes of T-DXd-induced ILD after standardized clinical management. It aimed to help readers understand the importance of standardized clinical management before and during T-DXd treatment. Regarding specific clinical management strategies

the article reviewed comprehensive management approaches for T-DXd-induced ILD based on clinical trial protocols and real-world experiences from both domestic and international perspectives

covering patient screening

patient education

ILD monitoring

diagnosis

and treatment. Before initiating T-DXd treatment

patient screening helps identify those at high risk for ILD

and T-DXd should be used cautiously in these high-risk patients. Effective patient education can enhance patient initiative

encouraging them to promptly report suspected symptoms

which contributes to early identification of ILD. During T-DXd treatment

it is important to regularly monitor symptoms and signs related to ILD

implement regular imaging monitoring and leverage multidisciplinary team collaboration to diagnose ILD as early as possible

thereby minimizing the risk of severe ILD. If symptoms or imaging suggest ILD

T-DXd treatment must be immediately interrupted

and relevant examinations should be completed to rule out other possible causes while considering corticosteroid treatment. Upon ILD diagnosis

subsequent T-DXd dose adjustments

corticosteroid therapy

and supportive treatments should be guided by severity. The article also explored whether patients with T-DXd-induced ILD can be re-treated

concluding that Grade 1 ILD patients might be eligible for re-treatment under specific conditions. In conclusion

the article reviewed the epidemiology

characteristics

clinical trial-recommended management strategies

and real-world management measures of T-DXd-induced ILD

integrating clinical expert experiences to summarize and discuss comprehensive management strategies for it. This aimed to enhance clinicians' understanding of T-DXd-induced ILD and provide valuable insights for early identification

timely diagnosis

and proper management of it.

关键词

Keywords

references

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