SIRT Does Not Improve Overall Survival vs Sorafenib in Hepatocellular Carcinoma
Researchers randomly assigned 459 patients to receive SIRT with 90Y-loaded resin microspheres for 2 to 5 weeks or oral sorafenib 400 mg twice daily continuously.
Selective internal radiotherapy (SIRT) with yttrium-90 (90Y) resin microspheres did not prolong survival among patients with advanced- or intermediate-stage hepatocellular carcinoma (HCC) after unsuccessful chemoembolization, according to a study published in Lancet Oncology.1
Sorafenib is the standard treatment for patients with advanced HCC and prolongs overall survival, but many patients are unresponsive to therapy after undergoing transarterial chemoembolization.
For the open-label, phase 3 SARAH trial (ClinicalTrials.gov Identifier: NCT01482442), researchers randomly assigned 459 patients to receive SIRT with 90Y-loaded resin microspheres for 2 to 5 weeks or oral sorafenib 400 mg twice daily continuously.
The median follow-up periods were 27.9 months and 28.1 months in the SIRT and sorafenib arms, respectively. Median overall survival in the SIRT group was 8.0 months (95% CI, 6.7-9.9) compared with 9.9 months (95% CI, 8.7-11.4) in the sorafenib arm (hazard ratio [HR], 1.15; 95% CI, 0.94-1.41; P = .018).
In the SIRT arm, 77% of patients reported at least 1 serious adverse event (AE) compared with 82% in the sorafenib arm. The most frequently reported grade 3 or worse AEs in both study arms were fatigue (9% vs 19%, SIRT vs sorafenib, respectively), liver dysfunction (11% vs 13%), increased liver enzymes (9% vs 7%), hematological abnormalities (10% vs 14%), diarrhea (1% vs 14%), abdominal pain (3% vs 6%), increased creatinine levels (2% vs 6%), and hand-foot skin reaction (<1% vs 6%).
There were 19 and 12 treatment-related deaths in the SIRT and sorafenib arms, respectively.
The authors concluded that OS did not differ significantly, but added that “[q]uality of life and tolerance might help when choosing between the two treatments. Better local efficacy of SIRT suggests that it might be appropriate to evaluate SIRT in patients with less-advanced hepatocellular carcinoma.”
- Vilgrain V, Pereira H, Assenat E, et al. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017 Oct 26. doi: 10.1016/S1470-2045(17)30683-6 [Epub ahead of print]