Primary Study Endpoint

Progression-Free Survival

  • The primary endpoint of the SIRFLOX study was progression-free survival (PFS)
  • PFS response was determined by an independent central imaging review panel
  • SIRFLOX was designed to detect a relative risk reduction of 25% with 80% power and 95% confidence (Hazard Ratio = 0.75)

Secondary Study Endpoints

Progression-Free Survival in the Liver

  • PFS in the liver measures progression of tumours in the liver only
  • This secondary study endpoint is important as liver metastases are commonly the only, or dominant, site of disease in patients with mCRC and are the major site of disease influencing survival, with the majority of mCRC patients dying of liver failure due to the local effects of metastases
  • PFS response is determined by an independent central imaging review panel
  • SIR-Spheres® Y-90 resin microspheres are specifically targeted to treat liver metastases

Objective Response Rate

  • The objective response rate (ORR) defines the proportion of patients with a complete response or a partial response
  • ORR was assessed in the liver and at any site
  • ORR was determined by an independent central imaging review panel

Liver Resection Rate   

  • SIRFLOX assessed the percentage of previously non-resectable patients who become able to undergo potentially curative surgical resection of their remaining liver tumours as a secondary endpoint
  • Previous studies have shown that a proportion of patients receiving SIR-Spheres Y-90 resin microspheres can have a sufficient downsizing of their liver tumours to enable surgical resection
  • SIR-Spheres Y-90 resin microspheres induce contralateral hypertrophy in untreated segments of the liver, which increases future liver remnant and may enable surgical resection
  • SIR-Spheres Y-90 resin microspheres may provide new treatment options for patients who were previously inoperable

Safety and Toxicity   

  • Assessing safety and toxicity is another important secondary endpoint
  • In earlier studies, SIR-Spheres Y-90 resin microspheres were well-tolerated, without adding to the toxicity of chemotherapy alone

Overall Survival  

  • Overall survival will be assessed as the primary endpoint in a combined analysis of the SIRFLOX study with two other large post marketing studies, named FOXFIRE and FOXFIRE Global
  • FOXFIRE and FOXFIRE Global also added SIR-Spheres Y-90 resin microspheres to a current chemotherapy regimen in the first-line treatment of more than 500 patients recently diagnosed with non-resectable mCRC and completed patient enrolment at the end of 2014
  • The results of this pre-planned analysis of >1,100 patients pooled from these three studies are expected during 2017

Other Secondary Endpoints   

  • A further secondary endpoint is health-related quality of life

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