SIR-Spheres recommended in new oncology clinical guidelines for treatment of metastatic colorectal cancer

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Newly published European Society for Medical Oncology (ESMO) clinical guidelines for the treatment of metastatic colorectal cancer endorse radioembolisation, specifically with yttrium-90 (Y90) resin microspheres, as a clinically proven technology to “prolong time to liver tumour progression” in patients who have failed to respond to available chemotherapy options.

SIR-Spheres (Sirtex) is the only product used for radioembolisation or selective internal radiation therapy (SIRT) that is recommended in the new ESMO guidelines, a press release from the company says.

The new guidelines, authored on behalf of the ESMO Guidelines Working Group by Eric Van Cutsem (Leuven, Belgium), Andres Cervantes (Valencia, Spain), Bernard Nordlinger (Paris, France) and Dirk Arnold (Freiberg, Germany) were published online in a 4 September 2014 supplement to the Annals of Oncology.

“We are very pleased that the authors of major international clinical guidelines in the treatment of metastatic colorectal cancer have singled out radioembolisation, and particularly our unique product, SIR-Spheres y90 resin microspheres, as an appropriate treatment for patients with colorectal liver metastases that have failed to respond to chemotherapy,” said Nigel Lange, CEO of Sirtex Medical Europe GmbH.  “We believe the new ESMO clinical guidelines will have an immediate effect on improving patient access to SIR-Spheres y90 resin microspheres across Europe.”

As clinical evidence for the new ESMO recommendation, the authors cited a multicentre randomised controlled study conducted by Alain Hendlisz (Brussels, Belgium) and colleagues.  The study was a “Phase III trial comparing intravenous fluorouracil infusion with yttrium-90 resin microspheres for liver-limited metastatic colorectal cancer refractory to standard chemotherapy.”

In April 2013, Sirtex announced that it had completed recruitment of patients for SIRFLOX, a 500-patient randomised clinical study that compares the use of SIR-Spheres in combination with standard chemotherapy to standard chemotherapy alone in the treatment of patients recently diagnosed with inoperable metastatic colorectal cancer, which is much earlier in the treatment paradigm. Data from SIRFLOX are expected in 2015.