Characterization of Patients with Unresectable Hepatocellular Carcinoma in REFLECT Who Achieved Tumor Response or Alpha-Fetoprotein Response When Treated with Lenvatinib

Background: The phase 3 REFLECT study (NCT01761266) established lenvatinib’s noninferiority to sorafenib for unresectable hepatocellular carcinoma (uHCC). This subanalysis examines patients treated with lenvatinib according to the depth of their tumor response and their status as an alpha-fetoprotein (AFP) responder/nonresponder. Methods: Of 478 lenvatinib-treated patients, 194 achieved an objective response by mRECIST per independent imaging review. Patients with tumor response were further categorized by their maximal tumor reduction (assessed every 8 weeks). Patients were also assessed according to their AFP response (≥20% reduction from baseline by week 8) status, including AFP responders (n = 227) and nonresponders (n = 73). Results: Median duration of response in patients with ≥75% (n = 59)/≥50% to