In an investigator-initiated phase III SIRveNIB trial in Asia-Pacific patients reported in the Journal of Clinical Oncology, Chow et al found no difference in overall survival with selective internal radiation therapy, or radioembolization, vs sorafenib (Nexavar) in patients with unresectable locally advanced hepatocellular carcinoma.
In the open-label trial, 360 patients with or without portal vein thrombosis (PVT) who were not amenable to curative treatment from 27 sites in 11 countries in the Asia-Pacific region were randomized between July 2010 and May 2016 to yttrium-90 (90Y) resin microspheres radioembolization (n = 182) or sorafenib at 800 mg/d (n = 178). Randomization was stratified by study center and the presence of PVT (30.8% of radioembolization group, 30.3% of sorafenib group). The primary endpoint was overall survival in the intention-to-treat population.
In total, 28.6% of the radioembolization group and 9.0% of the sorafenib group did not receive the assigned treatment, with no significant crossover occurring for either group. Median overall survival was 8.8 months in the radioembolization group vs 10.0 months in the sorafenib group (hazard ratio [HR] = 1.1, P = .36). In the treated population, median overall survival was 11.3 vs 10.4 months (HR = 0.86, P = .27).
Grade ≥ 3 adverse events occurred in 27.7% of the radioembolization group vs 50.6% of the sorafenib group (P < .001); the most common of these adverse events in the radioembolization group were ascites (3.8% vs 2.5%), abdominal pain (2.3% vs 1.2%), and radiation hepatitis (1.5% vs 0%). The most common in the sorafenib group were palmar-plantar erythrodysesthesia syndrome (16.7% vs 0%), diarrhea (3.7% vs 0%), fatigue (3.7% vs 0%), anemia (2.5% vs 0%), and ascites. Serious adverse events occurred in 20.8% of the radioembolization group vs 35.2% of the sorafenib group.
The investigators concluded, “In patients with locally advanced [hepatocellular carcinoma], [overall survival] did not differ significantly between [radioembolization] and sorafenib. The improved toxicity profile of [radioembolization] may inform treatment choice in selected patients.”
The work was supported in part by Sirtex Medical.
Pierce K.H. Chow, MBBS, FRCS, PhD, of the Division of Surgical Oncology, National Cancer Centre Singapore, is the corresponding author for the Journal of Clinical Oncology article.
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