CHICAGO — Patients with hepatocellular carcinoma who underwent surgical resection or local ablation experienced similar rates of recurrence when treated with adjuvant sorafenib or placebo, according to results of a randomized phase 3 study presented at the 2014 ASCO Annual Meeting.
In the STORM trial, Jordi Bruix, MD, of the University of Barcelona, and colleagues evaluated data from 1,114 patients with hepatocellular carcinoma who had an intermediate (54%) or high (46%) recurrence risk after surgical resection or local ablation. The median age of patients was 59 years, and 62% of patients were Asian. A majority of patients underwent resection (81%) and 97% had Child-Pugh class A disease.
Bruix and colleagues assigned 556 patients to 400 mg twice-daily sorafenib (Nexavar, Bayer). The other 558 patients received placebo. Treatment continued for a maximum 4 years.
RFS served as the primary endpoint.
After 464 events, researchers observed no significant differences in RFS (HR=0.94; 95% CI, 0.78-1.134), time to recurrence (HR=0.891; 95% CI, 0.735-1.081) or OS (HR=0.995; 95% CI, 0.761-1.3) among patients who received sorafenib vs. placebo.
Patients assigned sorafenib received treatment for a shorter median duration (12.5 months vs. 22.2 months) and in lower mean daily doses (578 mg vs. 778 mg) compared with patients assigned placebo.
More patients in the sorafenib arm discontinued treatment due to treatment-related adverse events (24% vs. 7%) and consent withdrawal (17% vs. 6%).
Incidence of grade 3 to grade 4 adverse events was higher in the sorfaenib arm (69% vs. 42%). The most common grade 3 to grade 4 adverse events in the sorafenib arm were hand–foot skin reaction (28%), hypertension (7%) and diarrhea (6%).
For more information:
Bruix J. Abstract #4006. Presented at: 2014 ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Disclosure: Researchers report consultant/advisory roles or employment/leadership positions with, honoraria or research funding from and stock ownership in ArQule, Bayer, Biocompatibles, BioSphere Medical, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Lilly, NanoString Technologies, Novartis, Roche and Sirtex Medical.