Objectives: To compare the time trade-off (TTO) utility values of EQ-5D-5L health states elicited from different general populations in Asia. Methods: We analyzed the TTO data from seven Asian EQ-5D-5L valuation studies in which utility values of 86 EQ-5D-5L health states were elicited from general population samples. An eight-parameter multiplicative regression model including five dimension parameters (mobility [MO], self-care, usual activities [UA], pain/discomfort, anxiety/depression) and three level parameters (level 2 [L2], level 3 [L3], and level 4 [L4]) was used to model the data from each of the populations. The model coefficients were compared to understand how the valuations of EQ-5D-5L health states differ. Results: For dimension parameters, Korea and Indonesia generally had the highest and lowest values among the populations, respectively; UA and MO commonly had the highest and lowest values among the parameters, respectively. For level parameters, Singapore and Korea generally had the highest and lowest values, respectively; L2 showed less variance compared to L3 and L4. Koreans, Indonesians, and Singaporeans appeared to have different health preferences compared with other populations. Conclusion: Utility values of EQ-5D-5L health states differ among Asian populations, suggesting that each health system should establish and use its own value set.
The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279) was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC) not amenable to curative therapies.
Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.