CLDN18.2靶向治疗药物相关恶心、呕吐的预防和管理专家共识(2026年版)OA
Expert consensus on prevention and management of nausea and vomiting associated with CLDN18.2-targeted therapeutic drugs(2026 edition)
CLDN18.2是近年来胃癌、食管胃结合部腺癌、胰腺癌等消化系统肿瘤中备受关注的治疗靶点.CLDN18.2靶向治疗在临床研究和实践中显示出良好抗肿瘤效果的同时,也暴露出以恶心、呕吐为代表的特征性胃肠道不良反应,可能成为临床实践中影响患者生活质量、治疗依从性及疗效持续性的关键问题.现有基础及临床研究提示,此类不良反应主要与CLDN18.2在正常胃黏膜中的表达导致的在靶/脱瘤胃黏膜损伤相关,其发生机制、临床表现及管理策略均不同于传统抗肿瘤治疗药物相关恶心、呕吐,不能简单地沿用常规止吐模式.为进一步规范CLDN18.2靶向治疗药物相关恶心、呕吐的风险评估、预防、监测及全程管理,上海市抗癌协会抗肿瘤药物安全管理专业委员会组织相关领域专家,在系统回顾国内外循证医学证据并结合临床实践经验的基础上,采用推荐分级的评估、制定与评价(Grading of Recommendations,Assessment,Development and Evaluation,GRADE)方法和专家共识方法,围绕个体化风险评估、分层止吐预防、胃黏膜保护、输注优化、暴发性呕吐处理、中西医辅助干预、患者宣教随访及多学科管理等关键问题提出推荐意见,以期为临床规范化管理此类特异性毒性、提高治疗依从性及患者获益提供指导.本共识最大的创新点在于首次针对CLDN18.2靶向治疗药物相关恶心、呕吐这一具有独特发生机制的毒性,提出区别于传统化疗所致恶心、呕吐(chemotherapy-induced nausea and vomiting,CINV)管理的全流程、全周期、多学科管理策略,为该类药物的临床安全应用和不良反应规范化管理提供参考.
Claudin 18.2(CLDN18.2)has emerged as an important therapeutic target in gastrointestinal malignancies,particularly gastric cancer,adenocarcinoma of gastroesophageal junction,and pancreatic cancer.While CLDN18.2-targeted therapies have demonstrated promising antitumor efficacy in both clinical trials and real-world practice,they are also associated with characteristic gastrointestinal toxicities,most notably nausea and vomiting,which may adversely affect patients'quality of life,treatment adherence,and sustained therapeutic efficacy.Increasing preclinical and clinical evidence suggests that these adverse events are primarily attributable to on-target/off-tumor gastric mucosal injury resulting from physiological CLDN18.2 expression in normal gastric mucosa.Consequently,their underlying mechanisms,clinical manifestations,and management strategies differ substantially from those of conventional cancer therapy-induced nausea and vomiting,and therefore should not be managed using standard antiemetic protocols alone.To standardize the risk assessment,prevention,monitoring,and full course management of CLDN18.2-targeted therapy-related nausea and vomiting,the Antitumor Drug Safety Management Professional Committee of Shanghai Anti-Cancer Association convened a multidisciplinary expert panel.Based on a systematic review of the domestic and international evidence and extensive clinical experience,recommendations were developed using the Grading of Recommendations,Assessment,Development and Evaluation(GRADE)approach and a formal consensus methodology.The consensus addresses key aspects of clinical management,including individualized risk assessment,risk-adapted antiemetic prophylaxis,gastric mucosal protection,infusion optimization,management of breakthrough nausea and vomiting,integrative supportive care combining Western and traditional Chinese medicine,patient education and follow-up,as well as multidisciplinary management.Recommendations were formulated to provide practical guidance for the standardized management of this specific toxicity,improvement of treatment adherence,and enhancement of patient benefit.Notably,this is the first expert consensus to propose a comprehensive,multidisciplinary,full-course and full cycle management strategy specifically tailored to the unique pathophysiological characteristics of CLDN18.2-targeted therapy-related nausea and vomiting,which distinguishes it from conventional chemotherapy-induced nausea and vomiting(CINV)management.This consensus is intended to provide practical guidance for the safe clinical application of CLDN18.2-targeted therapies and the standardized management of their associated adverse events.
上海市抗癌协会抗肿瘤药物安全管理专业委员会;林晓琳;肖秀英
上海交通大学医学院附属仁济医院肿瘤科
医药卫生
CLDN18.2靶向治疗恶心呕吐预防管理专家共识
CLDN18.2-targeted therapyNauseaVomitingPreventionManagementExpert consensus
《中国癌症杂志》 2026 (7)
700-716,17
上海东方英才计划拔尖项目(BJWS2025064). Shanghai Eastern Talent Plan Leading Project(BJWS2025064).
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