DESCRIPTION
Hepatic (liver) tumors can arise either as primary liver cancer or by metastasis to the liver from other tissues or organs. Surgical resection is presently the treatment of choice for hepatic tumors. Unfortunately, most hepatic tumors are unresectable at diagnosis. This is due either to the tumors anatomic location, size, and number of lesions, concurrent nonmalignant liver disease or insufficient hepatic reserve.
Selective internal radiation therapy (SIRT) via microspheres is being offered as a non-surgical technique that seeks to cure or palliate primary and metastatic tumors of the liver. Radioactive microspheres are injected using a syringe into the hepatic artery via an access route. This route is via a transfemoral catheter or a permanently implanted hepatic artery port with catheter. Once injected, the microspheres travel through the blood stream and target the tumor within the liver, delivering high doses of ionizing radiation (beta radionuclide yttrium-90 [90Y]). Treatment takes about 20-30 minutes and may be delivered under mild sedation.
There are commercial (e.g., TheraSpheresŪ, SIR-SpheresŪ) and non-commercial forms of 90Y microspheres. Non-commercial forms are mostly used outside the United States. While the commercial products use the same radioisotope (90Y) and have the same target dose (100 Gy), they differ in microsphere size profile, base material (i.e., resin versus glass) and size of commercially available doses. These physical characteristics of the active and inactive ingredients affect the flow of microspheres during injection, their retention at the tumor site, spread outside the therapeutic target region, and dosimetry calculations. Also, depending on the form of 90Y microspheres being used, monotherapy or therapy in combination with chemotherapy may be given.
Selective internal radiation via microspheres may also be referred to as a type of brachytherapy or radioembolization.
POLICY
Selective internal radiation therapy using intra-arterial injection of radiolabeled microspheres for the treatment of primary or metastatic liver tumors is considered investigational.
ADDITIONAL INFORMATION
Well-designed randomized controlled trials regarding this technology are lacking. Available published literature does not allow for conclusions regarding the effect of the technology on palliative outcomes, disease symptoms or long-term health outcomes. The current published studies do not validate improved survival rates with the use of this technology.
SOURCES
American Cancer Society. (2009, November). What's new in liver cancer research and treatment? Retrieved November 18, 2009 from http://www.cancer.org/docroot/CRI/content/CRI_2_4_6X_Whats_new_in_liver_cancer_research_and_treatment_25.asp?sitearea.
American College of Radiology. (2008 October). Practice guideline for radioembolization with microsphere brachytherapy device (RMBD) for treatment of liver malignancies. Retrieved November 18, 2009 from http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/ro/RMBD.aspx.
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2009). Selective internal radiation therapy for primary and metastatic tumors of the liver (8.01.43). Retrieved November 3, 2009 from BlueWeb. (35 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2006, June). Intrahepatic yttrium- 90 microsphere therapy for metastatic colorectal cancer. Retrieved December 17, 2007 from ECRI Institute. (16 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2006, June). Intrahepatic yttrium- 90 microsphere therapy for primary liver cancer. Retrieved December 17, 2007 from ECRI Institute. (19 articles and/or guidelines reviewed)
Gulec, S. A., Mesoloras, G., Dezarn, W. A., McNeillie, P., & Kennedy, A. S. (2007). Safety and efficacy of Y-90 microsphere treatment in patients with primary and metastatic liver cancer: The tumor selectivity of the treatment as a function of tumor to liver flow ratio. Journal of Translational Medicine, 5 (15). (Level 4 Evidence)
Hayes. Medical Technology Directory. (2008, July). Radioactive Yttrium-90 Microspheres for treatment of secondary liver cancer. Retrieved November 18, 2009 from www.Hayesinc.com/subscribers. (96 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2008, July). Radioactive Yttrium-90 Microspheres for treatment of primary liver cancer. Retrieved November 18, 2009 from www.Hayesinc.com/subscribers. (79 articles and/or guidelines reviewed)
Lim, L., Gibbs, P., Yip, D., Shapiro, J. D., Dowling, R., Smith, D., et al. (2005). Research Article. A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy. BioMed Central, 5 (132). (Level 4 Evidence)
National Comprehensive Cancer Network. (2009). NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. V.I.2010. Retrieved November 20, 2009 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site.
National Guideline Clearinghouse. National Center for Primary Care. (2007 November). ACR appropriateness criteria hepatic malignancy. Retrieved November 21, 2009 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=11558&string=liver+AND+cancer.
National Institute for Health and Clinical Excellence. (2004, September). Selective internal radiation therapy for colorectal metastases in the liver. Retrieved November 18, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG093guidance.pdf.
Salem, R., Lewandowski, R. J., Atassi, B., Gordon, S. C., Gates, V. L., Barakat, O., et al. (2005). Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): Safety, tumor response, and survival. Journal of Vascular and Interventional Radiology, 16 (12), 1627 - 1639. (Level 4 Evidence)
Sharma, R. A., Van Hazel, G. A., Morgan, B., Berry, D. P., Blanshard, K., Price, D., et al. (2007). Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. Journal of Clinical Oncology, 25 (9), 1099 - 1106. (Level 1 Evidence)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCDs for Wisconsin Physicians Service. (2009, August). LCD for selective internal radiation therapy (SIRT) for primary and secondary hepatic malignancy (90Y-Microsphere Hepatic Brachytherapy) (L30137). Retrieved November 18, 2009 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=30137&lcd_version=3&show=all.
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. Product approval information - licensing action. H980006 - TheraSpheresŪ. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H980006.
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. Product approval information - licensing action. SIR-SpheresŪ - P990065. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p990065.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 1/14/2010
ID_BT
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