Second-line systemic therapy with regorafenib improves overall survival among patients with hepatocellular carcinoma (HCC) regardless of prior sorafenib dose, according to a study being presented at the 2017 Gastrointestinal Cancers Symposium.1
Previously reported findings of the double-blind, phase 3 RESOURCE trial (ClinicalTrials.gov Identifier: NCT01774344) showed that treatment with regorafenib significantly reduced the risk of death by 37% compared with placebo among patients with HCC who progressed during sorafenib treatment (hazard ratio [HR], 0.63; 95% CI, 0.50-0.79; P < .001).
To explore the impact of first-line sorafenib therapy on outcomes of patients treated with second-line regorafenib, investigators analyzed efficacy and safety data from RESOURCE by the last sorafenib dose. Times from the initiation of sorafenib to progression on sorafenib and times from progression on sorafenib to start of regorafenib or placebo were similar between the regorafenib and placebo arms.
Among patients treated with 800 mg per day of sorafenib as the last sorafenib dose, median overall survival was 10.6 months (95% CI, 8.1-12.6) with regorafenib compared with 7.0 months (95% CI, 5.3-9.0) with placebo (HR, 0.67; 95% CI, 0.51-0.87)
Among those who received less than 800 mg per day of sorafenib before discontinuing therapy, patients treated with second-line regorafenib had a median overall survival of 10.6 months (95% CI, 7.4-14.0) vs 8.5 months (95% CI, 5.6-10.0) for the placebo arm (HR, 0.68; 95% CI, 0.48-0.97).
Median overall survival from the start of sorafenib was 26.0 months (95% CI, 22.6-28.1) with regorafenib vs 19.2 months (95% CI, 16.3-22.8) with placebo.
Among those who received regorafenib, 100% of patients treated with 800 mg and less than 800 mg of prior sorafenib experienced treatment-emergent adverse events; 92% and 93% of patients given 800 mg and less than 800 mg of sorafenib with placebo developed adverse events, respectively.
- Finn RS, Merle P, Granito A, et al. Outcomes with sorafenib (SOR) followed by regorafenib (REG) or placebo (PBO) for hepatocellular carcinoma (HCC): Results of the international, randomized phase 3 RESORCE trial. J Clin Oncol. 2017;35(suppl):4S. Abstract 344.