Intraoperative Radiation Therapy (IORT)
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.
Intraoperative radiation therapy (IORT) for the treatment of cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Intraoperative radiation therapy (IORT) for all other oncologic applications is considered investigational.
Intraoperative radiation therapy (IORT) is considered medically appropriate if ANY ONE of the following criteria are met:
Recurrent, noncentral cervical cancer with positive or close margins
Recurring uterine/endometrial cancer confined to the pelvis
Retroperitoneal/intra-abdominal sarcoma with positive or close margins
Extremity, trunk, head/neck soft tissue sarcoma with positive or close margins
Colon cancer with T4 or recurrent cancer
Rectal cancer with positive or close margins with T4 or recurrent cancer
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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.
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.
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2017). Intraoperative radiation therapy. (8.01.08). Retrieved March 7, 2018 from BlueWeb. (39 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)
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, October). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Soft tissue sarcoma v.1.2018. Retrieved March 7, 2018 from www.nccn.org.
National Comprehensive Cancer Network. (2018, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer v.1.2018. Retrieved March 7, 2018 from www.nccn.org.
National Comprehensive Cancer Network. (2018, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Rectal cancer v. 4.2017. Retrieved March 7, 2018 from www.nccn.org.
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)
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)
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.
Winifred C. Hayes, Inc. Medical Technology Directory. (2015, November, last update search November 2017). Intraoperative radiotherapy for treatment of early-stage breast cancer. Retrieved March 7, 2018 from www.Hayesinc.com/subscribers. (100 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 8/1985
MOST RECENT REVIEW DATE: 4/12/2018