Selective internal radiation therapy/radioembolization (RE) and sorafenib yield similar overall survival (OS) outcomes among patients with unresectable hepatocellular carcinoma (HCC), according to a study published in Journal of Clinical Oncology.1 RE may, however, have a superior toxicity profile.
For the phase 3 SIRveNIB study (ClinicalTrials.gov Identifier: NCT01135056), researchers randomly assigned 360 patients with locally advanced HCC to receive RE with yttrium-90 (90Y) resin microspheres or sorafenib 800 mg daily. Patients were enrolled regardless of portal vein thrombosis status and were unable to tolerate other curative therapies.
The median OS was 8.8 months for patients assigned to the RE group compared with 10.0 months in the sorafenib group (hazard ratio [HR], 1.1; 95% CI, 0.9-1.4; P = .36).
In total, 1468 treatment-emergent adverse events (AEs) were reported: 437 cases in the RE group vs 1031 in the sorafenib group. Significantly fewer patients had grade 3 or worse AEs in the RE group vs the sorafenib group (27.7% vs 50.6%; P < .001), and patients who received RE also had a lower rate of serious AEs (20.8% vs 35.2%, respectively).
The most frequently reported AEs included ascites, abdominal pain, anemia, and radiation hepatitis.
While neither therapy was superior for improving OS, the authors concluded that “the improved toxicity profile of RE may inform treatment choice in selected patients.”
- Chow PK, Gandhi M, Tan SB, et al. SIRveNIB: selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma. J Clin Oncol. 2018 Mar 2. doi: 10.1200/JCO.2017.76.0892 [Epub ahead of print]