Study shows SIR-Spheres Y-90 resin microspheres in liver cancer reduces side effects versus sorafenib with no impact on survival- Sirtex

Patients with advanced or inoperable Hepatocellular Carcinoma (HCC) who usually received one or two treatments with liver-directed SIR-Spheres Y-90 resin microspheres, from Sirtex, in the 459-patient French phase III SARAH study had similar survival compared to patients who received standard twice-daily systemic treatment with sorafenib, but with less than half the number and significantly fewer severe treatment-related adverse effects and significantly better Quality of Life.

Neither sorafenib nor SIR-Spheres Y-90 resin microspheres produced a statistically significant difference in Overall Survival (OS) of the patients we studied. The primary endpoint of Overall Survival by intention-to-treat was not significantly different (median 8.0 vs. 9.9 months). However the difference in the frequency and severity of side effects of patients treated with SIR-Spheres Y-90 resin microspheres versus sorafenib was striking.

Significantly fewer patients treated with SIR-Spheres Y-90 resin microspheres had any treatment-related side effects at all (76.5% vs. 94.0% for sorafenib), and these were also less severe (more than grade 3; 40.7% vs. 63.0%, respectively). Moreover, those patients treated with SIR-Spheres Y-90 resin microspheres who reported treatment-related side effects experienced a median of only 5 such events over the course of the SARAH study, compared to a median of 10 events in those who received sorafenib. General treatment-related symptoms such as fatigue (42% vs. 65%), abdominal pain (20% vs. 29%), nausea or vomiting (12% vs. 23%) and infection (4% vs. 11%) were also significantly less frequently reported and less severe for patients receiving SIR-Spheres Y-90 resin microspheres, compared to sorafenib. Data were presented at The International Liver Congress.