中国实用外科杂志2024，Vol.44Issue(7)：787-792,6.DOI:10.19538/j.cjps.issn1005-2208.2024.07.14
直肠癌新辅助免疫治疗相关不良反应分析:一项全国多中心回顾性研究
Adverse events of neoadjuvant immunotherapy for rectal cancer:a nationwide multicenter retrospective study
摘要
Abstract
Objective To analyze the immune-related adverse events(irAEs)and their management strategies in patients with rectal cancer receiving neoadjuvant immune checkpoint inhibitors(ICIs)therapy.Methods We conducted a retrospective study,including 100 rectal cancer patients who underwent irAEs after neoadjuvant immune therapy between September 2020 and March 2024 at seven centers nationwide.Baseline data,neoadjuvant treatment regimens,irAEs diagnosis and treatment,surgical outcomes,and follow-up information were collected.Results During neoadjuvant treatment,there were a total of 141 episodes of irAEs,with 32 patients(32％)experiencing more than one irAE.irAEs mainly occurred in the endocrine system,liver,skin,gastrointestinal tract,and musculoskeletal system,with 41,33,29,17and 7 times,respectively,and the median time of irAEs occurrence in each system was 31,18,12,32.5 and 29 days,respectively.Grade Ⅰ and Ⅱ irAEs occurred 131 times(92.9％),which could be managed with conservative treatment and symptomatic management.GradeⅢ and above irAEs occurred 10 times(7.1％),and after evaluation by a multi-disciplinary team(MDT),applying treatment such as glucocorticoids,immunosuppressants,and so on,ameliorated irAEs.Among them,7 patients permanently discontinued ICIs treatment,and 3 patients continued ICIs treatment.The severity of irAEs was not associated with whether patients received combined radiotherapy(P=0.858).Delayed irAEs occurred in 5 cases(5％).3 patients(3％)with clinical complete remission after neoadjuvant treatment opted for Watch & Wait strategy,while 97 patients(97％)underwent surgical treatment.11 cases(11.3％)had surgery-related complications.The median follow-up time after surgery was 12 months.Among the cases,97 patients(97％)achieved disease-free survival,1 patient(1％)experienced tumor recurrence,and 2 patients(2％)developed distant metastases.Conclusion There is a possibility of one or multiple irAEs occurring in neoadjuvant immunotherapy for rectal cancer,with the endocrine system,liver,and skin being the most commonly affected systems.Most irAEs can be alleviated with symptomatic treatment.For grade Ⅲand above irAEs,a MDT should be consulted to develop a diagnosis and treatment plan and most of them need to permanently discontinue ICIs.The severity of irAEs is not related to the usage of combined radiotherapy.After treatment,irAEs did not affect the safety of patients undergoing surgery,but vigilance is needed for delayed onset of irAEs.关键词
直肠癌/免疫治疗/免疫检查点抑制剂/免疫相关不良反应Key words
rectal cancer/immunotherapy/immune checkpoint inhibitor/immune-related adverse event分类
医药卫生引用本文复制引用
邱小原,周皎琳,林国乐,孙丽婷,王晨童,姚宏伟,王权,周爱萍,吴小剑,张卫,周雷..直肠癌新辅助免疫治疗相关不良反应分析:一项全国多中心回顾性研究[J].中国实用外科杂志,2024,44(7):787-792,6.基金项目
中央高水平医院临床科研专项项目(No.2022-PUMCH-C-005) （No.2022-PUMCH-C-005）
中国医学科学院医学与健康科技创新工程项目(No.2022-I2M-C&T-B-032) （No.2022-I2M-C&T-B-032）
