SIR-Spheres® Y-90 resin microspheres + chemo in mCRC

  • No statistically significant improvement of PFS at any site
  • Significantly improves median PFS in the liver by 7.9 months, from 12.6 to 20.5 months (p=0.002)1
  • 31% reduction in risk of progression in the liver (HR: 0.69; 95% CI 0.55-0.90; p=0.002) 1

SIR-Spheres Y-90 resin microspheres – the only SIRT supported by Level 1 evidence

PFS in the liver

Click HERE to learn more about the SIRFLOX Study

bev*: bevacizumab (bevacizumab allowed at investigator’s discretion, per institutional practice)
van Hazel GA et al. J Clin Oncol 2016; 34: 1723–1731.

 

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. SIR-Spheres Y-90 resin microspheres may only be distributed to a duly licensed or accredited facility capable of handling therapeutic medical isotopes. This product is radioactive and should thus be handled in accordance with all applicable standards and regulations. Intended Use / Indications For Use: SIR-Spheres Y-90 resin microspheres are approved for use in Argentina, Australia, Brazil, Canada, the European Union (CE Mark), Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In the US, SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Warnings / Precautions: Inadvertent delivery of the microspheres to locations other than the intended hepatic tumor may result in local radiation damage. Due to the radioactivity and the significant consequences of misplacing the microspheres in situ, this product must be implanted by physicians who have completed the Sirtex TEC training program. A SPECT scan of the upper abdomen immediately after implantation is recommended. Patients may experience abdominal pain immediately after administration and pain relief may be required. H-2 blocking agents may be administered the day before implantation and continued as needed to reduce gastric complications. Side Effects: Common side effects are fever, transient decrease of hemoglobin, mild to moderate abnormality of liver function tests, abdominal pain, nausea, vomiting, and diarrhea. Potential serious effects due to exposure to high radiation include acute pancreatitis, radiation pneumonitis, acute gastritis, radiation hepatitis, and acute cholecystitis. Contraindications: SIR-Spheres Y-90 resin microspheres should not be implanted in patients who have either had previous external beam radiation therapy to the liver, ascites, or are in clinical liver failure. This device is contraindicated in patients with markedly abnormal synthetic and excretory liver function tests, greater than 20% lung shunting of the hepatic artery blood flow, disseminated extra-hepatic malignant disease, and portal vein thrombosis. This device should not be implanted in patients determined via angiogram to have an abnormal vascular anatomy that would result in significant reflux of the hepatic arterial blood flow to the stomach, pancreas or bowel. Reference the Package Insert (www.sirtex.com) for a complete listing of indications, contraindications, side effects, warnings, and precautions.



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