SIRFLOX Key Findings

SIR-Spheres^® Y-90 resin microspheres + mFOLFOX6 (+ bev*) in mCRC

• No statistically significant improvement of PFS at any site.¹
• Statistically significant improvement of 7.9 months in median PFS in the liver, from 12.6 to 20.5 months representing a 31% reduction in risk of progression in the liver.¹
• Statistically significant increase of hepatic Depth of Response (DpR) by 20% in patients with >12% tumor burden and >100 day improvement in Time to Nadir compared to chemotherapy alone.²
• Three-fold increase in complete response rate in the liver.¹
• Statistically significant increase in hepatic response rate.¹

SIRFLOX was the first large, randomized, controlled, open-label, multicentre international study to examine the use of chemo-radiotherapy in the first-line treatment of colorectal liver metastases.

The study evaluated the efficacy and safety of adding SIR-Spheres Y-90 resin microspheres to a current first-line systemic chemotherapy in patients with unresectable colorectal liver metastases.

bev*: bevacizumab (bevacizumab allowed at investigator’s discretion, per institutional practice)
1. van Hazel GA et al. J Clin Oncol 2016; 34: 1723–1731.
2. Heinemann V et al. ESMO WCGIC, Annals of Oncology 2016; 27 (Suppl 2): Abs. O-014.

The SIRFLOX data were presented at ASCO 2015 by Professor Peter Gibbs, The Royal Melbourne Hospital, Australia, Co-Principal Investigator.