mCRC Clinical Studies

SIR-Spheres® Y-90 resin microspheres have been extensively investigated in the treatment of liver metastases from colorectal cancer (mCRC).

SIR-Spheres in first-line treatment of mCRC

  • Three large RCTs, SIRFLOX, FOXFIRE and FOXFIRE Global, investigated the use of SIR-Spheres Y-90 resin microspheres in addition to chemotherapy No additional benefit in Overall Survival was reported but they demonstrated a significantly increased Response Rate and median Progression Free Survival in the liver.1,2
  • A sub-group analysis on right-sided primary (RSP) patients showed that treating patients with FOLFOX-based chemotherapy + SIR-Spheres resulted in a statistically significant (p<0.008) and clinically meaningful (HR=0.64) 4.9-month median Overall Survival benefit compared to chemotherapy alone.3
  • Increased eligibility for hepatic resection following SIR-Spheres has been shown in the REsect study, a retrospective, blinded evaluation of CT scans from the SIRFLOX study patient cohort.4

SIR-Spheres in chemorefractory mCRC

  • Beyond first-line, multiple prospective studies and retrospective analyses have shown the efficacy across various endpoints when SIR-Spheres are used as a single agent, or in combination with chemotherapy.5-8

1. Van Hazel G et al. J Clin Oncol 2016; 34: 1723–1731.
2. Wasan HS et al. Lancet Oncol 2017; 18: 1159-1171
3. Gibbs P et al. Clin Col Cancer 2018; 17: e617-e629
4. Garlipp B et al. Br J Surg 2019; 106: 1837-1846.
5. Hendlisz A et al. J Clin Oncol 2010; 28: 3687–94.
6. Seidensticker R et al. Cardiovasc Interv Radiol 2012; 35; 1066‒73.
7. Cosimelli M et al. Br J Cancer 2010; 103: 324–31.
8. Kennedy A et al. J Gastrointest Oncol 2015; 6: 134‒42.

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