Sirtex Medical Limited has announced it completed patient enrolment in FOXFIRE and FOXFIRE Global, two large-scale multi-centre clinical trials that combine liver-directed radiation therapy with SIR-Spheres Y-90 resin microspheres to a chemotherapy regimen in over 560 inoperable metastatic colorectal cancer (mCRC) patients.
SIR-Spheres Y-90 resin microspheres are used to deliver radioembolisation, or SIRT, a technology used for liver tumors that cannot be operated upon, and can deliver significant, specific doses of radiation directly to towards the tumor, making it a marginally invasive radiation therapy technique.
Through a catheter infusion, millions of SIR-Spheres microspheres are directed into the liver, where they can target cancer cells with a radiation dose up to forty times higher than the one used in traditional radiotherapy, while preserving the healthy tissue surrounding the tumor area.
These spheres are produced by Sirtex Medical Limited and are indicated in the United States for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.
The data from these two clinical trials will be combined with previous findings from the SIRFLOX study, which will enable the development of a database comprising over 1,000 patients. This will allow researchers enough statistical significance to assess the efficacy of first-line SIR-Spheres microspheres combined with chemotherapy (versus chemotherapy alone) in improving overall survival mCRC patients suffering from liver metastases.
“We are very pleased that FOXFIRE and FOXFIRE Global have so quickly reached their ambitious enrolment goals,” Gilman Wong, CEO of Sirtex Medical Limited, said in a press release. “Announcing the results of the earlier SIRFLOX study remains our immediate priority. However, the fact that enrolment in all three studies is now complete presents us an unprecedented opportunity to demonstrate the important role that SIR-Spheres microspheres may play in the treatment of patients with mCRC, for whom liver tumours are all too often the greatest cause of failing health. We are grateful to the many doctors, nurses and other medical staff, and especially the patients and their families who have made this important undertaking possible.”
“Despite significant advances we have made in treating this disease with chemotherapy and biologically targeted therapies, optimising the care for patients with colorectal cancer that has spread to the liver remains a significant challenge in oncology,” explained one of the study’s lead investigators Professor Ricky Sharma, Consultant Clinical Oncologist at the Oxford University Hospitals NHS Trust. “For rectal cancer, the combination of radiotherapy and chemotherapy is an established standard of care. Treating the liver with the same combination of treatments has been difficult due to the sensitivity of healthy liver tissue to radiotherapy. These exciting clinical trials combine a safe form of internally administered radiotherapy with routine chemotherapy. Recruiting over 1,000 patients to these trials represents an important step forward in determining whether targeting these tumours with both treatments acting together is better than using chemotherapy on its own”, he added.
Study chief investigator Dr. Harpreet Wasan, Consultant and Reader in Medical Oncologist, Imperial College Healthcare, Hammersmith Hospital, London, further stated, “This is the reason why we needed to conduct definitive research in the early use of liver-directed radiotherapy with SIR-Spheres Y-90 resin microspheres in these patients. Completing enrolment in the FOXFIRE study is an important milestone in our work to address whether adding selective internal radiation therapy to first-line chemotherapy will provide an important gain in Overall Survival for patients with colorectal cancer liver metastases.”