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Regorafenib approved for previously treated advanced liver cancer

NICE has approved regorafenib as an option for advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, and have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

The clinical evidence to support the recommendation came from the international, phase 3 RESORCE trial, which included 573 patients with disease progression on sorafenib, who received either 160 mg regorafenib orally once daily for weeks 1 to 3 of each four‑week treatment cycle, or best supportive care (BSC). RESORCE included five clinical trial centres in the UK, with 20 patients randomised to treatment in four of the centres.

The results showed a small but statistically significant median overall survival (OS) gain of 2.8 months for regorafenib (10.6 months; 95% CI 9.1-12.1) compared with BSC (7.8 months; 95% CI 6.3-8.8). The hazard ratio for OS for regorafenib vs BSC was 0.63 (95% CI 0.50-0.79).

Median progression-free survival (PFS) was significantly better for regorafenib (3.1 months, 95% CI 2.8- 4.2) than BSC (1.5 months, 95% CI 1.4-1.6). The hazard ratio for PFS with regorafenib was 0.46 (95% CI 0.37-0.56).

The appraisal committee concluded that “regorafenib meets NICE's criteria to be considered a life-extending treatment at the end of life. The most plausible cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources for end-of-life treatments. Therefore, it is recommended for people with hepatocellular carcinoma who have had sorafenib and have an ECOG performance status of 0 or 1 and Child-Pugh grade A liver impairment.”


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