Yi-Min Zhang, Xin-Tong Wu, Jun-Zhe Yi, Jie Xu, Yu-Nan Zhang, Ning Lyu, Ming Zhao
{"title":"动脉FOLFOX与阿特唑单抗-贝伐单抗治疗不可切除肝癌的间接比较","authors":"Yi-Min Zhang, Xin-Tong Wu, Jun-Zhe Yi, Jie Xu, Yu-Nan Zhang, Ning Lyu, Ming Zhao","doi":"10.1159/000545891","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>A previous phase 3 FOHAIC-1 study demonstrated that hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen displayed favorable outcomes in advanced hepatocellular carcinoma (HCC) patients, including those with high-risk features (main portal tumor invasion and >50% liver infiltration). This study aimed to compare the treatment efficacy of HAIC-FOLFOX versus atezolizumab-bevacizumab in HCC patients.</p><p><strong>Methods: </strong>Individual patient data from the Chinese FOHAIC-1 study and aggregate data from the global IMbrave150 study were used to conduct an anchored matching-adjusted indirect comparison. Hazard ratios (HR) and restricted mean survival times (RMST) were calculated to assess survival differences. Landmark analysis was performed to evaluate time-sensitive treatment effects, and simulated treatment comparison (STC) was conducted as a sensitivity analysis. Rates of treatment-related adverse events (TRAEs) and TRAE-related discontinuations were also compared.</p><p><strong>Results: </strong>After matching baseline characteristics, HAIC showed a numerical OS benefit (HR 0.57, 95% CI, 0.30-1.08) and similar PFS benefit (HR 0.79, 95% CI, 0.43-1.47) compared to atezolizumab-bevacizumab in the overall population. In high-risk patients, HAIC demonstrated significantly improved OS (HR 0.30, 95% CI, 0.12-0.72) and 2.89-month longer RMST compared to atezolizumab-bevacizumab (95% CI, 0.15-5.64 months). Additionally, HAIC showed superior PFS (HR 0.25, 95% CI, 0.10-0.64) and 2.88-month longer RMST over atezolizumab-bevacizumab (95% CI, 0.90-4.86). Landmark analysis in the high-risk group revealed that HAIC was associated with significant improvements in both OS (HR 0.32, 95% CI, 0.13-0.79) and PFS (HR 0.24, 95% CI, 0.09-0.63) during the 0-12 months following treatment initiation. Sensitivity analysis using the anchored STC analysis yielded consistent results. HAIC was associated with lower rates of grade 3-4 TRAEs and TRAE-related discontinuation in both the overall population and the high-risk group.</p><p><strong>Conclusion: </strong>HAIC treatment provided superior survival benefits and a favorable safety profile compared to atezolizumab-bevacizumab in high-risk HCC patients.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":"1-18"},"PeriodicalIF":11.6000,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12113427/pdf/","citationCount":"0","resultStr":"{\"title\":\"Matching-Adjusted Indirect Comparison of Arterial FOLFOX and Atezolizumab-Bevacizumab in Unresectable Hepatocellular Carcinoma.\",\"authors\":\"Yi-Min Zhang, Xin-Tong Wu, Jun-Zhe Yi, Jie Xu, Yu-Nan Zhang, Ning Lyu, Ming Zhao\",\"doi\":\"10.1159/000545891\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>A previous phase 3 FOHAIC-1 study demonstrated that hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen displayed favorable outcomes in advanced hepatocellular carcinoma (HCC) patients, including those with high-risk features (main portal tumor invasion and >50% liver infiltration). This study aimed to compare the treatment efficacy of HAIC-FOLFOX versus atezolizumab-bevacizumab in HCC patients.</p><p><strong>Methods: </strong>Individual patient data from the Chinese FOHAIC-1 study and aggregate data from the global IMbrave150 study were used to conduct an anchored matching-adjusted indirect comparison. Hazard ratios (HR) and restricted mean survival times (RMST) were calculated to assess survival differences. Landmark analysis was performed to evaluate time-sensitive treatment effects, and simulated treatment comparison (STC) was conducted as a sensitivity analysis. Rates of treatment-related adverse events (TRAEs) and TRAE-related discontinuations were also compared.</p><p><strong>Results: </strong>After matching baseline characteristics, HAIC showed a numerical OS benefit (HR 0.57, 95% CI, 0.30-1.08) and similar PFS benefit (HR 0.79, 95% CI, 0.43-1.47) compared to atezolizumab-bevacizumab in the overall population. In high-risk patients, HAIC demonstrated significantly improved OS (HR 0.30, 95% CI, 0.12-0.72) and 2.89-month longer RMST compared to atezolizumab-bevacizumab (95% CI, 0.15-5.64 months). Additionally, HAIC showed superior PFS (HR 0.25, 95% CI, 0.10-0.64) and 2.88-month longer RMST over atezolizumab-bevacizumab (95% CI, 0.90-4.86). Landmark analysis in the high-risk group revealed that HAIC was associated with significant improvements in both OS (HR 0.32, 95% CI, 0.13-0.79) and PFS (HR 0.24, 95% CI, 0.09-0.63) during the 0-12 months following treatment initiation. Sensitivity analysis using the anchored STC analysis yielded consistent results. HAIC was associated with lower rates of grade 3-4 TRAEs and TRAE-related discontinuation in both the overall population and the high-risk group.</p><p><strong>Conclusion: </strong>HAIC treatment provided superior survival benefits and a favorable safety profile compared to atezolizumab-bevacizumab in high-risk HCC patients.</p>\",\"PeriodicalId\":18156,\"journal\":{\"name\":\"Liver Cancer\",\"volume\":\" \",\"pages\":\"1-18\"},\"PeriodicalIF\":11.6000,\"publicationDate\":\"2025-04-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12113427/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Liver Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000545891\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Liver Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000545891","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Matching-Adjusted Indirect Comparison of Arterial FOLFOX and Atezolizumab-Bevacizumab in Unresectable Hepatocellular Carcinoma.
Introduction: A previous phase 3 FOHAIC-1 study demonstrated that hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen displayed favorable outcomes in advanced hepatocellular carcinoma (HCC) patients, including those with high-risk features (main portal tumor invasion and >50% liver infiltration). This study aimed to compare the treatment efficacy of HAIC-FOLFOX versus atezolizumab-bevacizumab in HCC patients.
Methods: Individual patient data from the Chinese FOHAIC-1 study and aggregate data from the global IMbrave150 study were used to conduct an anchored matching-adjusted indirect comparison. Hazard ratios (HR) and restricted mean survival times (RMST) were calculated to assess survival differences. Landmark analysis was performed to evaluate time-sensitive treatment effects, and simulated treatment comparison (STC) was conducted as a sensitivity analysis. Rates of treatment-related adverse events (TRAEs) and TRAE-related discontinuations were also compared.
Results: After matching baseline characteristics, HAIC showed a numerical OS benefit (HR 0.57, 95% CI, 0.30-1.08) and similar PFS benefit (HR 0.79, 95% CI, 0.43-1.47) compared to atezolizumab-bevacizumab in the overall population. In high-risk patients, HAIC demonstrated significantly improved OS (HR 0.30, 95% CI, 0.12-0.72) and 2.89-month longer RMST compared to atezolizumab-bevacizumab (95% CI, 0.15-5.64 months). Additionally, HAIC showed superior PFS (HR 0.25, 95% CI, 0.10-0.64) and 2.88-month longer RMST over atezolizumab-bevacizumab (95% CI, 0.90-4.86). Landmark analysis in the high-risk group revealed that HAIC was associated with significant improvements in both OS (HR 0.32, 95% CI, 0.13-0.79) and PFS (HR 0.24, 95% CI, 0.09-0.63) during the 0-12 months following treatment initiation. Sensitivity analysis using the anchored STC analysis yielded consistent results. HAIC was associated with lower rates of grade 3-4 TRAEs and TRAE-related discontinuation in both the overall population and the high-risk group.
Conclusion: HAIC treatment provided superior survival benefits and a favorable safety profile compared to atezolizumab-bevacizumab in high-risk HCC patients.
期刊介绍：
Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.
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