机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[2]Karsh Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, California.[3]Department of Surgery and Cancer, Imperial College London, United Kingdom.[4]Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Austria.[5]The Eighth Hospital of Xi'an City, Xi'an Jiaotong University, Shaanxi, China.[6]Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.[7]Department of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[8]Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany.[9]Department of Rheumatology and Immunology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.临床科室免疫风湿科河北医科大学第四医院[10]Department of Diagnostic Radiology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.[11]Department of Hematology and Hematopoietic Stem Cell Transplantation, City of Hope National Medical Center, Duarte, California.[12]Division of Hematology/Oncology, Department of Medicine, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco.[13]Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.[14]Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.[15]Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.[16]Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.[17]Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.[18]Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale "A Avogadro," Novara, Italy.[19]National and Local Joint Engineering Research Center of Biodiagnosis and Biotherapy, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[20]Shaanxi Provincial Clinical Medical Research Center of Infectious Diseases, Xi'an, China.[21]Key Laboratory of Surgical Critical Care and Life Support (Xi'an Jiaotong University), Ministry of Education, Xi'an, China.
Immune checkpoint inhibitors (ICIs) are increasingly used in patients with advanced hepatocellular carcinoma (HCC). However, data on ICI therapy in patients with advanced HCC and impaired liver function are scarce.To conduct a systematic review and meta-analysis to determine the efficacy and safety of ICI treatment for advanced HCC with Child-Pugh B liver function.PubMed, Embase, Web of Science, and Cochrane Library were searched for relevant studies from inception through June 15, 2022.Randomized clinical trials, cohort studies, or single-group studies that investigated the efficacy or safety of ICI therapy for Child-Pugh B advanced HCC were included.The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guideline was followed to extract data. A random-effects model was adopted if the heterogeneity was significant (I2 > 50%); otherwise, a fixed-effect model was used.The objective response rate (ORR) and overall survival (OS) were considered to be the primary efficacy outcomes of ICI treatment for Child-Pugh B advanced HCC, and the incidence of treatment-related adverse events (trAEs) was set as the primary measure for the safety outcome.A total of 22 studies including 699 patients with Child-Pugh B and 2114 with Child-Pugh A advanced HCC comprised the analytic sample (median age range, 53-73 years). Upon pooled analysis, patients treated with ICIs in the Child-Pugh B group had an ORR of 14% (95% CI, 11%-17%) and disease control rate (DCR) of 46% (95% CI, 36%-56%), with a median OS of 5.49 (95% CI, 3.57-7.42) months and median progression-free survival of 2.68 (95% CI, 1.85-3.52) months. The rate of any grade trAEs in the Child-Pugh B group was 40% (95% CI, 34%-47%) and of grade 3 or higher trAEs was 12% (95% CI, 6%-23%). Compared with the Child-Pugh A group, the ORR (odds ratio, 0.59; 95% CI, 0.43-0.81; P < .001) and DCR (odds ratio, 0.64; 95% CI, 0.50-0.81; P < .001) were lower in the Child-Pugh B group. Child-Pugh B was independently associated with worse OS in patients with advanced HCC treated with ICIs (hazard ratio, 2.72 [95% CI, 2.34-3.16]; adjusted hazard ratio, 2.33 [95% CI, 1.81-2.99]). However, ICIs were not associated with increased trAEs in the Child-Pugh B group.The findings of this systematic review and meta-analysis suggest that although the safety of ICI treatment was comparable between patients with HCC with vs without advanced liver disease and the treatment resulted in a significant number of radiologic responses, survival outcomes are still inferior in patients with worse liver function. More study is needed to determine the effectiveness of ICI treatment in this population.
基金：
This study was supported by
grant 82170626 from the National Natural Science
Foundation of China and grant 2022SF-451 from
the Natural Science Foundation of Shaanxi
Province.
第一作者机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
共同第一作者：
通讯作者：
通讯机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[3]Department of Surgery and Cancer, Imperial College London, United Kingdom.[18]Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale "A Avogadro," Novara, Italy.[19]National and Local Joint Engineering Research Center of Biodiagnosis and Biotherapy, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[20]Shaanxi Provincial Clinical Medical Research Center of Infectious Diseases, Xi'an, China.[21]Key Laboratory of Surgical Critical Care and Life Support (Xi'an Jiaotong University), Ministry of Education, Xi'an, China.[*1]Department of Surgery and Cancer, Imperial College London, Hammersmith Campus, Du Cane Road, London W12 0HS, UK[*2]Department of Infectious Diseases, The Second Affiliated Hospital of Xi’an Jiaotong University, No. 157 XiWu Rd, Xi’an 710004, Shaanxi Province, China
推荐引用方式(GB/T 7714)：
Xie Enrui,Yeo Yee Hui,Scheiner Bernhard,et al.Immune Checkpoint Inhibitors for Child-Pugh Class B Advanced Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis[J].JAMA ONCOLOGY.2023,9(10):1423-1431.doi:10.1001/jamaoncol.2023.3284.
APA：
Xie Enrui,Yeo Yee Hui,Scheiner Bernhard,Zhang Yue,Hiraoka Atsushi...&Ji Fanpu.(2023).Immune Checkpoint Inhibitors for Child-Pugh Class B Advanced Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.JAMA ONCOLOGY,9,(10)
MLA：
Xie Enrui,et al."Immune Checkpoint Inhibitors for Child-Pugh Class B Advanced Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis".JAMA ONCOLOGY 9..10(2023):1423-1431
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