The SIRveNIB abstract published on–line in the Journal of Clinical Oncology states that treatment of locally advanced hepatocellular carcinoma (HCC) with a single treatment of SIR–Spheres® Y–90 resin microspheres results in Overall Survival not significantly different from twice–daily oral sorafenib, but with significantly better tumour response and fewer and less severe adverse events.
The study was conducted by The Asia–Pacific Hepatocellular Carcinoma Trials Group (AHCC) in collaboration with the National Cancer Centre Singapore and Singapore Clinical Research Institute (SCRI) and supported by the National Medical Council Singapore and Sirtex Medical Limited.

The lead author of the SIRveNIB abstract, Professor Pierce Chow, Senior Consultant Surgeon at the National Cancer Centre Singapore and the Singapore General Hospital, reported that: “Asia Pacific patients with locally advanced primary liver cancer (HCC or hepatocellular carcinoma) with no spread (metastases) outside the liver who are treated with Y–90 resin microspheres have a significantly better tumour response rate (TRR) compared to sorafenib, despite 28.6% (n=52) of patients not receiving Y–90 therapy as planned (TRR – 16.5% for Y–90 resin microspheres vs 1.7% for sorafenib, respectively; p < 0.001). Moreover, patients experienced fewer, less serious adverse events when compared with those treated with sorafenib. There were no statistically significant differences in the primary endpoint of overall survival (OS) between the two treatments.”

Although the median OS in the intent–to–treat group1 was 8.54 months for Y–90 resin microspheres vs. 10.58 months for sorafenib, respectively (p=0.203), there was a trend in improvement in median OS in the treated group2 for Y–90 resin microspheres (11.27 vs. 10.41 months, p=0.273). While Y–90 resin microspheres were not superior to sorafenib regarding OS, Professor Chow, who is also Professor and Course Director at the Duke–NUS Medical School, indicated that “the better tumour response and tolerability of Y–90 resin microspheres offers a compelling treatment alternative for patients with advanced hepatocellular carcinoma, for whom there are limited treatment options available.”

SIRveNIB was designed to compare the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium–90 [Y–90] resin microspheres (SIR–Spheres; Sirtex Medical Limited, North Sydney, Australia) versus sorafenib (Nexavar®; Bayer HealthCare Pharmaceuticals, Berlin, Germany), a systemic treatment that is the current standard of care in advanced hepatocellular carcinoma. The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation.

“Each year we are making good progress in treating liver cancer. The deeper we go in our research the better we are able to understand how the cancer behaves and we are able to widen the treatments options for our patients. The results reinforced our belief that with the right people on the research project, we can get the best results. I am grateful to our partners for collaborating in this study,” added Professor Soo Khee Chee, Director of NCCS.

“Completion of the investigator–led SIRveNIB study represents a significant milestone in Asia Pacific liver cancer research, and underscores the strong private–public partnership that exists between Sirtex Medical Limited, the National Cancer Centre Singapore and Singapore Clinical Research Institute. We look forward to the presentation of more complete results of SIRveNIB at the impending ASCO Annual Meeting,” said Associate Professor Teoh Yee Leong, CEO Singapore Clinical Research Institute.