BlueCross BlueShield of Tennessee Medical Policy Manual

Intraoperative Radiation Therapy (IORT)

DESCRIPTION

Intraoperative radiation therapy (IORT) is delivered directly to exposed tissues during surgery. It 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. The evidence is insufficient to determine the effects of IORT on all cancer types.

POLICY

See also:

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The evidence for IORT includes nonrandomized clinical studies and some systematic reviews. Relevant outcomes are overall survival and treatment-related morbidity. Study quality was judged to be low given the heterogeneous patient populations, lack of comparison groups, heterogeneous delivery of IORT doses, and the concomitant heterogeneous delivery of other treatments.

SOURCES 

American College of Radiology. (2010). ACR appropriateness criteria®. Retreatment of recurrent head and neck cancer after prior definitive radiation. Retrieved June 2, 2011 from: http://www.acr.org.

American College of Radiology. (2015). ACR-ABS practice parameter for the performance of radionuclide-based high-dose-rate brachytherapy. Retrieved December 9, 2015 from www.acr.org.

Azinovic, I., Monge, R. M., Aristu, J. J., Salgado, E., Villafranca, E., Hidalgo, O. F., et al. (2003). Intraoperative radiotherapy electron boost followed by moderate doses of external beam radiotherapy in resected soft-tissue sarcoma of the extremities. Radiotherapy and Oncology, 67 (2003), 331-337. (Level 4 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2016). Intraoperative radiation therapy. (8.01.08). Retrieved January 11, 2017 from BlueWeb. (38 articles and/or guidelines reviewed)

Call, J. A., Stafford, S. L., Petersen, I. A., & Haddock, M. G. (2014). Use of intraoperative radiotherapy for upper-extremity soft-tissue sarcomas: analysis of disease outcomes and toxicity. American Journal of Clinical Oncology, 37 (1), 81-85. (Level 4 evidence - Independent)

Calvo, F. A., Sole, C. V., Polo, A., Cambeiro, M., Montero, A., Alvarez, A., et al. (2014). Limb-sparing management with surgical resection, external-beam and intraoperative electron-beam radiation therapy boost for patients with primary soft tissue sarcoma of the extremity. Radiation Therapy Oncology, 2014, 190, 891-898. (Level 4 evidence)

Moojen, W., Vleggeert-Lancamp C., Krol, D. and Dijkstra, S. (2011, May) Long-term results: adjuvant radiotherapy in en bloc resection of sacrococcygeal chordoma is advisable. Spine. 36(10):E656-61. Abstract retrieved October 18, 2016 from PubMed database.

National Comprehensive Cancer Network. (2017). Cervical cancer. Retrieved October 18, 2016 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017). Colon cancer. Retrieved January 30, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017). Rectal cancer. Retrieved January 30, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017). Soft tissue sarcoma. Retrieved January 30, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017). Uterine neoplasms. Retrieved January 30, 2017 from the National Comprehensive Cancer Network.

Oertel, S., Treiber, M., Zahlten-Hinguranage, A., Eichin, S., Roeder, F., Funk, A., et al. (2006). Intraoperative electron boost radiation followed by moderate doses of external beam radiotherapy in limb-sparing treatment of patients with extremity soft-tissue sarcoma. International Journal of Radiation Oncology, 64 (5), 1416-1423, (Level 4 evidence)

Pan, E., Goldberg, S. I., Chen, Y. L., Giraud, C., Hornick, J. L., Nielsen, G. P., et al. (2014). Role of post-operative radiation boost for soft tissue sarcomas with positive margins following pre-operative radiation and surgery. Journal of Surgical Oncology, 110 (7), 817-822. Abstract retrieved January 12, 2017 from PubMed database.

Roeder, F., & Krempien, R. (2017). Intraoperative radiation therapy (IORT) in soft-tissue sarcoma. Radiation oncology, 12 (20), 1-18. (Level 4 evidence - Industry sponsored)

Tinkle, C. L., Weinberg, V., Braunstein, S. E., Wustrack, R., Horvai, A., Jahan, T., et al. (2015). Intraoperative radiotherapy in the management of locally recurrent extremity soft tissue sarcoma. Sarcoma, 2015, Article ID 913565. (Level 4 evidence - Independent)

Tran, Q. N., Kim, A. C., Gottschalk, A. R., Wara, W. M., Phillips, T. L., O’Donnell, R. J., et al. (2006). Clinical outcomes of intraoperative radiation therapy for extremity sarcomas. Sarcoma, 2006, Article ID 91671, 1-6. (Level 4 evidence - Independent)

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.fda.gov.

U. S. Food and Drug Administration. (2012, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K121653. Retrieved December 9, 2015 from http://www.fda.gov.

U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K133655. Retrieved December 9, 2015 from http://www.fda.gov.

Wagner, T., Kobayashi, W., Dean, S., Goldberg, S., Kirsch, D., Suit, H., et al., (2009, January). Combination short-course preoperative irradiation, surgical resection, and reduced-field high-dose postoperative irradiation in the treatment of tumors involving the bone. International Journal of Radiation Oncology, 1, 73 (1), 259-66. Abstract retrieved October 18, 2016 from PubMed database.

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)

Winifred C. Hayes, Inc. Medical Technology Directory. (2015, November). Intraoperative radiotherapy for treatment of early-stage breast cancer. Retrieved December 8, 2015 from www.Hayesinc.com/subscribers. (100 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  8/1985

MOST RECENT REVIEW DATE:  5/11/2017

ID_BT

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