Abstract
Simple SummaryRegorafenib after sorafenib therapy improved survival in patients with advanced hepatocellular carcinoma in the RESORCE study. The aim of our retrospective study was to investigate the predictors of response and outcome of regorafenib therapy in patients with unresectable hepatocellular carcinoma in whom sorafenib therapy had failed. We demonstrated that albumin-bilirubin grade at the initiation of regorafenib therapy is an independent predictor of disease control, progression-free survival, and overall survival. Patients with albumin-bilirubin grade 2 and an alpha-fetoprotein level of ≥20 ng/mL had the worst progression-free survival (after regorafenib therapy) and overall survival (after regorafenib and sorafenib therapy). Thus, a combination of albumin-bilirubin grade and alpha-fetoprotein level can be used to stratify patients with unresectable hepatocellular carcinoma by progression-free survival and overall survival probability for sorafenib–regorafenib sequential therapy.In the RESORCE study, regorafenib after sorafenib therapy improved survival in patients with advanced hepatocellular carcinoma (HCC). In total, 88 patients with unresectable HCC who received sorafenib–regorafenib sequential therapy were enrolled. The objective response rate and disease control rate were 19.3% and 48.9%, respectively, for regorafenib therapy (median duration: 8.1 months). Median progression-free survival (PFS) after regorafenib therapy was 4.2 months (95% CI: 3.2–5.1). The median overall survival (OS; from initiation of either sorafenib or regorafenib) was not reached in this cohort. According to multivariate Cox regression analyses, albumin-bilirubin (ALBI) grade at the initiation of regorafenib therapy is an independent predictor of disease control, PFS, and OS. Moreover, the combination of ALBI grade 2 and an alpha-fetoprotein (AFP) level of ≥20 ng/mL was an independent predictor of PFS (hazard ratio (HR): 3.088, 95% CI: 1.704–5.595; p < 0.001) for regorafenib therapy, and OS for both regorafenib (HR: 3.783, 95% CI: 1.316–10.88; p = 0.014) and sorafenib–regorafenib sequential (HR: 4.603, 95% CI: 1.386–15.29; p = 0.013) therapy. A combination of ALBI grade and AFP level can be used to stratify patients with unresectable HCC by PFS and OS probability for sorafenib–regorafenib sequential therapy.
Highlights
Multiple lines of therapy can improve overall survival (OS) in cancer
The combination of ALBI grade 2 and an AFP level of ≥20 ng/mL was an independent predictor of progression-free survival (PFS) in the model based on both ALBI grade and AFP level (Table 3, hazard ratio (HR): 3.088, 95% CI: 1.704–5.595, p < 0.001)
We explored whether factors before the initiation of regorafenib therapy were predictive of OS after sorafenib–regorafenib sequential therapy
Summary
Multiple lines of therapy can improve overall survival (OS) in cancer. For advanced hepatocellular carcinoma (HCC), the median OS increases from 11–14 months to 35 months after two or more lines of systemic therapy [1,2,3]. Information regarding the survival benefit of sequential therapy and its optimal regimen is limited [8,9]. In the RESORCE study, regorafenib was first demonstrated to have survival benefits, exhibiting a hazard ratio (HR) of 0.63 versus placebo after failure of sorafenib therapy; regorafenib was subsequently approved for second-line treatment of patients with advanced HCC [1,10,11]. It remains unclear who may benefit most from sorafenib–regorafenib sequential therapy. Identification of potential responders may guide the selection of optimal patients for sorafenib–regorafenib sequential therapy in advance
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