Regorafenib for Taiwanese patients with unresectable hepatocellular carcinoma after sorafenib failure: Impact of alpha‐fetoprotein levels

Abstract

Background and Aims Regorafenib has demonstrated its survival benefit for unresectable hepatocellular carcinoma (uHCC) patients in a phase III clinical trial. We aimed to assess the efficacy and tolerability of regorafenib and the predictors of treatment outcomes in Taiwanese patients. Methods We analyzed the survival, best overall response, predictors of treatment outcomes, and safety for uHCC patients who had tumor progression on sorafenib therapy and received regorafenib as salvage therapy between March 2018 and November 2020. Results Eighty‐six patients with uHCC were enrolled (median age, 66.5 years; 76.7% male). The median regorafenib treatment duration was 4.0 months (95% confidence interval [CI], 3.6–4.6). The most frequently reported adverse events were hand‐foot skin reaction (44.2%), diarrhea (36.0%), and fatigue (29.1%). No unpredictable toxicity was observed during treatment. The median overall survival (OS) with regorafenib was 12.4 months (95% CI, 7.8–17.0) and the median progression‐free survival (PFS) was 4.2 months (95% CI, 3.7–4.7). Of 82 patients with regorafenib responses assessable, 4 patients (4.9%) achieved a partial response, and 33 (40.2%) had stable disease, leading to a disease control rate (DCR) of 45.1% (n = 37). Patients possessing baseline AFP < 400 ng/ml exhibited a markedly longer median OS, median PFS, and higher DCR compared with their counterparts (15.7 vs. 8.1 months, 4.6 vs. 3.7 months, 60.9% vs. 27.5%, respectively). Despite possessing high baseline AFP levels, patients with early AFP response (>10% reduction at 4 weeks or >20% reduction at 8 weeks after regorafenib administration) exhibited comparable treatment outcomes to those with baseline AFP < 400 ng/ml. Conclusions The results of this real‐world study verified the tolerability and efficacy of regorafenib treatment for uHCC patients who failed prior sorafenib therapy, especially for those with lower baseline AFP levels or with early AFP response.

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“…Lastly, a higher CLIP score was associated with increased mortality in our study. Although our analysis did not establish an independent association of tumor morphological parameters or the presence of splenic vein thrombosis, the integration of these parameters in the CLIP score suggested a potential association, as supported by Hsu et al's study, which demonstrated increased mortality with a higher CLIP score [ 36 ]. Our analysis indicated that among patients with Child-Pugh class B, the risk of death was 1.21 times higher compared to those with Child-Pugh class A. Additionally, although not statistically significant, the risk of death was 2.81 times higher in patients with Child-Pugh class C compared to those with class A, aligning with findings reported by Hassan-Kadle et al [ 37 ].…”

Impact of post‐progression survival in second‐line treatment with molecular target agents for unresectable hepatocellular carcinoma

“…A search of the PubMed database identified 24 cohorts in 23 studies encompassing 2074 patients treated with REG (Figure 1 and Table ) 11,14–35 . Similarly, six cohorts from six studies comprising 621 patients treated with RAM 12,36–40 were identified, as well as seven cohorts from six studies involving 1240 patients treated with CAB 13,23,33,41–43 (Figure 1 and Tables and , respectively).…”

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