Adverse events of neoadjuvant immunotherapy for rectal cancer:a nationwide multicenter retrospective study
QIU Xiao-yuan
SUN Li-ting
WANG Chen-tong
YAO Hong-wei
WANG Quan
ZHOU Ai-ping
WU Xiao-jian
ZHANG Wei
ZHOU Lei
ZHOU Jiao-lin
LIN Guo-le
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.
Keywords：rectal cancerimmunotherapyimmune checkpoint inhibitorimmune-related adverse event
Publication Date：2024-07-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 787-792 )