FOXFIRE and FOXFIRE Global studies complete patient enrolment

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Combined data from more than 1,000 patients is being collected to assess the overall survival benefit of adding first-line SIR-Spheres Y-90 resin microspheres treatment to a current chemotherapy regimen for inoperable metastatic colorectal cancer.

Sirtex has announced the completion of patient enrolment in FOXFIRE and FOXFIRE Global, two large multicentre studies that added liver-directed radiation therapy with SIR-Spheres Y-90 resin microspheres to a current standard of care chemotherapy regimen in the first-line treatment of more than 560 patients recently diagnosed with inoperable metastatic colorectal cancer.

By previous design, the data of FOXFIRE and FOXFIRE Global will be combined with the findings of 500-patient SIRFLOX study to form a database of more than 1,000 patients that has sufficient statistical power to evaluate whether first-line SIR-Spheres microspheres in combination with a standard-of-care chemotherapy versus chemotherapy alone can significantly increase the overall survival of patients with colorectal cancer liver metastases. The results of this combined study are expected to be known in the first half of 2017.

“We are very pleased that FOXFIRE and FOXFIRE Global have so quickly reached their ambitious enrolment goals,” said Gilman Wong, CEO of Sirtex. “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 metastatic colorectal cancer, 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.”

The FOXFIRE Study, which enrolled more than 360 patients in 32 UK cancer centres, was initiated in 2008 by the Oxford Oncology Clinical Trials Office (OCTO) in collaboration with the UK National Cancer Research Institute. It is sponsored by the University of Oxford, and funded by the Bobby Moore Fund for Cancer Research UK, the Experimental Cancer Medicine Centre (ECMC) Network and Sirtex.

The FOXFIRE chief investigators are Ricky Sharma, consultant clinical oncologist at the Oxford University Hospitals NHS Trust, UK, and Harpreet Wasan, consultant medical oncologist, Imperial College Healthcare, Hammersmith Hospital, London, UK.

“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,” Sharma said.

“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.”

Wasan added: “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.”

 

FOXFIRE Global, which enrolled more than 200 patients and was funded by Sirtex, began in 2013 in a network of more than 80 centres in Australia, New Zealand, Asia Pacific, Israel, Western Europe and the United States. The principal investigator of FOXFIRE Global is Peter Gibbs, associate professor of Medical Oncology, Royal Melbourne Hospital and Western Hospital, Melbourne, Australia.

“Completing these three studies was an enormous undertaking, but it is no less enormous than the need for more effective ways to treat colorectal cancer that has metastasised to the liver, which is the most common site of its spread and affects several hundred thousand patients worldwide each year,” Gibbs explained. “Obviously, we do not yet know if this combination of chemo-radiotherapy will prove successful in early treatment of metastatic colorectal cancer, but we do know from published data that metastatic colorectal cancer patients who no longer respond to chemotherapy have already benefitted from selective internal radiation therapy, or SIRT, as it is more widely known.”