Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study

Masatoshi Kudo; Richard S. Finn; Shukui Qin; Kwang–Hyub Han; Kenji Ikeda; Ann‐Lii Cheng; Arndt Vogel; Francesco Tovoli; Kazuomi Ueshima; Hiroshi Aikata; Carlos López; Marc Pracht; Zhiqiang Meng; Bruno Daniele; Joong‐Won Park; D. Palmer; Toshiyuki Tamai; Kenichi Saito; Corina E. Dutcus; Riccardo Lencioni

doi:10.1016/j.jhep.2022.09.006

Abstract

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This analysis of data taken from a completed clinical trial (REFLECT) looked for any link between objective response and overall survival time in individuals with unresectable HCC receiving anti-angiogenic treatments. Significantly longer median overall survival was found for responders (21.6 months) vs. non-responders (11.9 months). Overall survival was also significantly longer for responders vs. non-responders (based on objective response status at 2, 4, and 6 months) in the landmark analysis. Our results indicate that objective response is an independent predictor of overall survival in this setting, confirming its validity as a rapid marker of efficacy that can be applied in phase II trials; however, further validation is required to determine is validity for other systemic treatments (e.g. immunotherapies), or as a surrogate of overall survival.

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