SIRFLOX Key Findings

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

• No statistically significant improvement of PFS at any site.¹
• Risk of first progression in the liver as per competing risk analysis significantly lower for patients receiving SIR-Spheres Y-90 resin microspheres. The improvement was 7.9 month with an HR of 0.69 corresponding to a 31% reduction in risk of progression in the liver at any point in time.¹
• Statistically significant increase of hepatic Depth of Response (DpR) by 20% in patients with >12% tumour burden and >100 day increase 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
• A retrospective analysis showed a statistically significant increase in number of patients rendered technically resectable following the addition of SIR-Spheres Y-90 resin microspheres to chemo.³

SIRFLOX was the first large, randomised, 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.

1. van Hazel GA et al. J Clin Oncol 2016; 34:1723–31.
2. Heinemann V et al. ESMO WCGIC, Annals of Oncology 2016; 27 (Suppl 2): Abs. O-014.
3. Garlipp B et al. E-AHPBA 2017; Abs. FP 15.08