Sirtex Medical Limited has announced that the results of the SIRFLOX study with SIR-Spheres Y-90 resin microspheres have been published on-line in the Journal of Clinical Oncology (JCO), the leading peer-reviewed publication of the American Society of Clinical Oncology (ASCO). Initial study findings were reported in an oral abstract presentation at the ASCO Annual Congress in Chicago, USA, in May 2015.
JCO has published the SIRFLOX study as a “Rapid Communication”, which they define as a commitment to freely disseminate ground-breaking and practice-changing information so that it may benefit all readers and patients.
Lead author and the study’s co-principal investigator, Prof. Guy A van Hazel of the University of Western Australia, Perth, Australia, said “In the primary endpoint of the study, patients with non- resectable liver-dominant or liver-only colorectal cancer who received FOLFOX-based first-line chemotherapy alone had a median Progression-Free Survival (PFS) at any site of 10.2 versus 10.7 months in those that received chemotherapy plus SIR-Spheres, but this difference was not statistically significant. However, the addition of SIR-Spheres Y-90 resin microspheres to chemotherapy significantly prolonged PFS in the liver, from a median of 12.6 months in the chemotherapy control arm compared to 20.5 months in the SIR-Spheres arm, which translated to a 31 percent reduction in the risk of tumour progression in the liver. Long-term disease control is critical as liver metastases eventually cause the death of the majority of the hundreds of thousands of patients who get colorectal cancer that cannot be removed by surgery.”
Gilman Wong, CEO of Sirtex Medical Limited, said that, “Today’s publication of the SIRFLOX study results represents both a culmination and a beginning for our company. SIRFLOX has been for us a ten-year journey to demonstrate in the clearest scientific terms that SIR-Spheres Y-90 resin microspheres belong among the first-line options that oncologists can use to treat mCRC. The publication of SIRFLOX in JCO is definitive recognition of the relevance of our technology in the control of liver metastases from colorectal cancer.”
Mr Wong added that, “We remain hopeful that our pre-planned, combined analysis of the SIRFLOX data with the findings of the FOXFIRE and FOXFIRE Global studies, which will be available in 2017, will give us a clear indication of the survival benefit associated with adding SIR-Spheres Y-90 resin microspheres to a standard-of-care chemotherapy.”
The SIRFLOX study recruited 530 patients who had been diagnosed with unresectable mCRC at 87 medical centres in Australia, Europe, Israel, New Zealand, and USA, between October 2006 and April 2013. Of these 530 patients, 263 control patients were randomized to be treated with the mFOLFOX6 regimen of 5FU, leucovorin and oxaliplatin, with the biological agent bevacizumab allowed at local investigator’s discretion. The other 267 patients received selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres in addition to the mFOLFOX6 chemotherapy regimen (± bevacizumab).