DESCRIPTION
Intraoperative radiation therapy (IORT) is designed to increase the intensity of radiation directly delivered to tumors. The tumor volume and associated tissues at risk for micrometastatic spread are directly visualized at the time of the surgery. IORT is delivered directly to the tumor volume, and normal or uninvolved tissues are not exposed to radiation because they are removed or shielded from the treatment field.
IORT is performed with applicators and cones that attach to the treatment head of high-energy medical linear accelerators and that are designed to direct radiation to defined surface structures. Most individuals are concurrently treated with high dose external beam photon irradiation.
POLICY
Intraoperative radiation therapy (IORT) is considered investigational.
ADDITIONAL INFORMATION
There is insufficient scientific evidence to show that intraoperative radiation is as effective as established standards of practice in improving health outcomes.
SOURCES
Abeloff, M. D., Armitage, J. O., Niederhuber, J., E., Kastan, M. B., & McKenna, W. G. (Eds.). (2008). Abeloff: Clinical Oncology (4th ed., pp. 1550 - 1551). Philadelphia: Elsevier, Inc.
American College of Radiology. (2008). ACR appropriateness criteria. Retrieved June 30, 2009 from http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonRadiationOncologyRectalAnalWorkGroup/RecurrentRectalCancerUpdateinProgress.aspx.
BlueCross BlueShield Association, Medical Policy Reference Manual. (4:2003). Intraoperative Radiation Therapy (8.01.08). Retrieved June 30, 2009 from BlueWeb.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, March). Intracavity balloon brachytherapy for early-stage breast cancer. Retrieved June 27, 2007 from ECRI Institute. (16 articles and/ or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, April). Accelerated partial-breast irradiation using intracavitary brachytherapy to treat early-stage breast cancer. Retrieved June 30, 2009 from ECRI Institute. (26 articles and/or guidelines reviewed)
Holmes, D., Baum, M. & Joseph, D. (2007). The TARGIT trial: targeted intraoperative radiation therapy versus conventional postoperative whole-breast radiotherapy after breast-conserving surgery for the management of early-stage invasive breast cancer (a trial update). American Journal of Surgery, 194 (4), 507 - 510. (Level 1 Evidence)
Hulvat, M., Hansen, N., & Jeruss, J. (2009). Multidisciplinary care for patients with breast cancer. The Surgical Clinics of North America, 89 (1), 133 - 176. (Level 5 Evidence)
Intra, M., Leonardi, C., Luini, A., Veronesi, P., Gennari, R., Gatti, G., et al. (2005) Full-dose intraoperative radiotherapy with electrons in breast surgery: broadening the indications. Archives of Surgery, 140 (10), 936-939. (Level 4 Evidence)
Miller, R. (2005). Miller’s Anesthesia (6th ed. pp. 2656 - 2657). Philadelphia: Elsevier, Inc.
Takamori, H., Hiraoka, T., Kanemitsu, K., Tsuji, T., Hamada, C., & Baba, H. (2006). Identification of prognostic factors associated with early mortality after surgical resection for pancreatic cancer-under-analysis of cumulative survival curve. World Journal of Surgery, 30 (2), 213 - 218. (Level 4 Evidence)
Technology Evaluation Center. (2007, August). Accelerated partial breast irradiation as sole radiotherapy after breast-conserving surgery for early stage breast cancer. (Vol. 22, No. 4). Chicago: BlueCross BlueShield Association. (94 articles and/or guidelines reviewed)
U.S. Food and Drug Administration. (1989, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K891261. Retrieved June 30, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=74571.
Williams, C., Reynolds, H., Delaney, C., Champagne, B., Obias, V., Joh, Y., et al. (2008). Clinical results of intraoperative radiation therapy for patients with locally recurrent and advanced tumors having colorectal involvement. American Journal of Surgery, 195 (3), 405 - 409. (Level 4 Evidence)
ORIGINAL EFFECTIVE DATE: 8/1985
MOST RECENT REVIEW DATE: 8/13/2009
ID_BT
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