Minireviews
Copyright ©The Author(s) 2022.
World J Hepatol. Jun 27, 2022; 14(6): 1074-1086
Published online Jun 27, 2022. doi: 10.4254/wjh.v14.i6.1074
Table 1 Summary of survival data from phase III randomized controlled trials of second- or later-line treatments in patients with advanced hepatocellular carcinoma
Ref.
Study design
Treatment arms
n
Patient population
Key findings
Zhu et al[20], REACHRandomized, placebo-controlled, double-blind, multicenter, phase III trialRamucirumab or placebo565Patients with advanced HCC with previous progression or intolerance to sorafenibRamucirumab vs placebo. Median OS: 9.2 mo (95%CI: 8.0-10.6) vs 7.6 mo (95%CI: 6.0-9.3), HR = 0.87 (95%CI: 0.72-1.05) P = 0.14. Median PFS: 2.8 mo (95%CI: 2.7-3.9) vs 2.1 mo (95%CI: 1.6-2.7), HR = 0.63 (95%CI: 0.52-0.75) P < 0.0001
Zhu et al[44], REACH-2Randomized, placebo-controlled, double-blind, multicenter, phase III trialRamucirumab or placebo292Patients with advanced HCC with previous progression or intolerance to sorafenib, AFP ≥ 400 ng/mLRamucirumab vs placebo. Median OS (7.6 mo follow-up): 8.5 mo (95%CI: 7.0-10.6) vs 7.3 mo (95%CI: 5.4-9.1), HR = 0.710 (95%CI: 0.531-0.949) P = 0.0199. Median PFS: 2.8 mo (95%CI: 2.8-4.1) vs 1.6 mo (95%CI: 1.5-2.7), HR = 0.452 (95%CI: 0.339-0.603) P < 0.0001
Bruix et al[33], RESORCERandomized, double-blind, parallel-group, phase III trialBSC + regorafenib or placebo573Patients with advanced HCC with previous progression or intolerance to sorafenibBSC + regorafenib vs placebo. Median OS: 10.6 mo (95%CI: 9.1-12.1) vs 7.8 mo (95%CI: 6.3-8.8), HR = 0.63 (95%CI: 0.50-0.79) one-sided P < 0.0001. Median PFS (RESIST 1.1): 3.4 mo (95%CI: 2.9-4.2) vs 1.5 mo (95%CI: 1.4-1.5), HR = 0.43 (95%CI: 0.35-0.52) P < 0.0001
Abou-Alfa et al[39], CELESTIALRandomized, double-blind, placebo-controlled, phase III trialCabozantinib or placebo773Patients with advanced HCC with previous progression or intolerance to sorafenibCabozantinib vs placebo. Median OS: 10.2 mo (95%CI: 9.1-12.0) vs 8.0 mo (95%CI: 6.8-9.4), HR = 0.76 (95%CI: 0.63-0.92) P = 0.005. Median PFS: 5.2 mo (95%CI: 4.0-5.5) vs 1.9 mo (95%CI: 1.9-1.9), HR = 0.44 (95%CI: 0.36-0.52) P < 0.001
AFP: Alpha-fetoprotein; BSC: Best supportive care; CI: Confidence interval; HCC: Hepatocellular carcinoma; HR: Hazard ratio; OS: Overall survival; PFS: Progression-free survival.