SIRT Shows No Survival Benefit in SORAMIC Study Palliative Cohort
The results of the palliative cohort of the SORAMIC study indicate that there is no confirmed clinical advantage to combining selective internal radiation therapy (SIRT) with standard sorafenib versus treatment with sorafenib alone. However, a subgroup analysis suggests a benefit for the combined therapy in certain patient groups.
Researchers presented the study results at the International Congress of the Liver 2018, which took place from April 11-15 in Paris, France.
SORAMIC ((SORAfenib in combination with local MICro-therapy guided by gadolinium-EOB-DTPA-enhanced MRI) began in February 2010 and includes three separate diagnostic, local ablation, and palliative sub-studies. The palliative cohort consisted of 424 patients with inoperable hepatocellular carcinoma (HCC) who were not candidates for transarterial chemoembolization (TACE). The patients were randomized to be treated with either SIRT with yttrium-90 (Y-90) resin microspheres plus sorafenib or only sorafenib. The researchers assessed overall survival (OS) as the primary endpoint in the intention-to-treat population.
Results showed that the median OS was 12.1 months in the SIRT combined with sorafenib arm and 11.5 months in the sorafenib arm. In the per-protocol group, the median OS was 14.1 months in the group who received SIRT and sorafenib and 11.1 months in the sorafenib arm.
When a subgroup of patients aged 65 years or younger were analyzed, there was a survival benefit found for SIRT and sorafenib. The benefit was also seen in patients with a non-alcoholic etiology of cirrhosis and patients who did not have cirrhosis.
“There remains a significant unmet need for new treatment approaches in patients with unresectable HCC, and SIRT had shown promising results in previous, non-randomized studies,” said Dr. Jens Ricke from the Ludwig-Maximilians-University in Munich, Germany, who presented the results. “We believe our results have generated some very interesting new hypotheses in terms of the types of HCC patients that might benefit from combination therapy of SIRT and sorafenib, and we hope to explore these further in the future.”
Selective internal radiation therapy (SIRT) fails to extend survival in the SORAMIC study palliative cohort [press release]. EurekAlert. April 13, 2018.