BlueCross BlueShield of Tennessee Medical Policy Manual

Brachytherapy and Accelerated Partial Breast Irradiation for Breast Cancer

DESCRIPTION

Brachytherapy is a type of radiation therapy (either low or high dose) that uses radioactive materials implanted temporarily or permanently into tissue. The implants can be solid or liquid isotopes. They can be implanted interstitially (needles or seeds), intracavitary (balloon) or as intraluminal therapy. When used in combination or as an adjunct to whole-breast irradiation it is referred to as local ‘boost’ therapy (e.g. MammoSite® Radiation Therapy System).

Conventional treatment of early-stage breast cancer involves either a total mastectomy (removal of the breast and affected nodes) or lumpectomy also known as breast conservation therapy (BCT). A lumpectomy is typically followed by external beam radiation therapy of the whole breast. For individuals diagnosed with early stage (I or II) breast cancer, survival after lumpectomy followed by whole breast radiotherapy has been shown to be equivalent to survival after mastectomy. Accelerated radiotherapy approaches have been proposed to make the regimen less burdensome for patients with early-stage breast cancer at low risk of recurrence. When the timeframe for whole breast irradiation is shortened by increasing the dose at each session it can be referred to as accelerated whole breast irradiation.

Another approach to reducing radiotherapy treatment time is accelerated partial-breast irradiation (APBI). By treating a focused area of the breast with concentrated dosing can local tissue damage can occur and failure to adequately treat multicentric tumors and cancer that has spread to nearby lymph nodes may also be a risk. Several methods can be used to deliver APBI, including brachytherapy, focused external-beam radiotherapy, or intraoperative radiotherapy, which occurs at the time of surgery.

A new technology using external applicators to deliver radiation to targeted locations, without implanting radioactive materials, is being investigated. This procedure is known as non-invasive brachytherapy (e.g. AccuBoost®).

POLICY

See also:  Intraoperative Radiation Therapy (IORT)

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Staging of the disease is determined by tumor size, the degree of invasiveness, lymph node involvement, and axillary lymph node involvement. Stage I describes invasive breast cancer in which the tumor measures up to 2 cm and no lymph nodes are involved. Stage IIB describes invasive breast cancer that the tumor is larger than 5 cm across but does not grow into the chest wall or skin. The cancer has not spread to the lymph nodes or to distant sites. For the purposes of this policy, Stages I to IIB are considered early-stage breast cancer.

Given the limited follow-up durations and clinically informative conclusions on accelerated partial-breast irradiation studies this method of breast conserving irradiation remains investigational.

Evidence for noninvasive breast brachytherapy to provide boost radiation to the tumor bed is very limited; therefore this technique is considered investigational.

SOURCES

Agency for Healthcare Research and Quality. (2013) Research Activity, No. 390: Older women with breast cancer experience more complications with brachytherapy than whole breast irradiation. Retrieved April 8, 2016 from: http://www.ahrq.gov.  

American College of Radiology / American Brachytherapy Society (2015) ACR_ABS Practice parameter for the performance of radionuclide-based high-dose-rate brachytherapy. Retrieved April 8, 2016 from:  http://www.acr.org.

American College of Radiology / American Society for Radiation Oncology. (2010). ACR-ASTRO practice guideline for the performance of high-dose-rate brachytherapy. Retrieved October 19, 2011 from http://www.acr.org.

American College of Radiology. (2015) Conservative surgery and radiation — stage I and II breast carcinoma. Retrieved January 24, 2017 from: https://acsearch.acr.org.

American Society for Radiation Oncology (ASTRO) (2016, September) Accelerated partial breast irradiation: executive summary for the update of an ASTRO evidence-based consensus statement. Retrieved January 25, 2017 from: https://www.astro.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017) Accelerated breast irradiation after breast conserving surgery for early stage breast cancer. (8.01.13). Retrieved January 24, 2017 from BlueWeb. (52 articles and/or guidelines reviewed)

Christoudias, M, Collett, A., Stull, T, Gracely, E., Frazier, T., Barrio, A. (October, 2013) Are the American Society for Radiation Oncology Guidelines Accurate Predictors of Recurrence in Early Stage Breast Cancer Patients Treated with Balloon-Based Brachytherapy? International Journal of Surgical Oncology. Vol. 2013, ID 829050. (Level 4 evidence)

ECRI Institute. Health Technology Information Service. Emerging Technology Report. (2012). Accelerated partial breast irradiation using intracavitary brachytherapy to treat early stage breast cancer. Retrieved October 18, 2011 from ECRI Institute.

Garsha, A., Ferraro, D., DeWees, T., Deshields, T., Margenthaler, J., Cyr, A., et. al. (December, 2013) A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer. International Journal of Radiation Oncology.1; 87(5): 1043–1050. (Level 3 Evidence)

Genebes, C. Chand, M., Gal, J. Gautier, M., Raoust, I. Ihrai, T. et. al. (2014, October) Accelerated partial breast irradiation in the elderly: 5-year results of high-dose rate multi-catheter brachytherapy. Radiation Oncology. 9:115 (Level 3 evidence)

Marta, G., Macedo, C., Carvalho, H.,  Hanna, S., da Silva, J., Riera, R. (2015, January) Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. Radiotherapy Oncology. 114(1):42-9. Abstract retrieved from PubMed database January 24, 2017.

National Comprehensive Cancer Network. (2016). NCCN Clinical Practice Guidelines in Oncology®. Breast cancer V 2.2016. Retrieved January 24, 2017 from http://www.nccn.org

National Institute for Heath and Clinical Excellence. (2008, July). Brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision. Interventional procedural guidance Retrieved January 24, 2017 from: http://www.nice.org .

Shaitelman, S., Vicini, F., Beitsch, P., Haffty, B., Keisch, M., and Lyden, M. (2010, October) Five-year outcome of patients classified using the american society for radiation oncology consensus statement guidelines for the application of accelerated partial breast Irradiation. Cancer 2010;116:4677-85. (Level 3 evidence)

Smith, G., Jiang, J. Buchholz, T., Xu, Y. Hoffman, K., Giordano, S., et. al., (February 2014) Benefit of Adjuvant Brachytherapy Versus External Beam Radiation for Early Breast Cancer: Impact of Patient Stratification on Breast Preservation. International Journal of Radiation Oncology. 1; 88(2): 274–284. (Level 4 evidence)

Smith, G., Xu, Y., Buchholz, T., Giordano, S., Jiang, J., Shih, Y., et. al., (2012, May) Association between treatment with brachytherapy vs whole- breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. Journal of the American Medical Association. 307(17): 1827–1837 (Level 4 evidence)

Strnad, V., Ott, O. Hildebrandt, G., Kauer-Dorner, D., Knauerhase, H., Major, T., et. al. (2016, January) 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 387(10015):229-38. Abstract retrieved from PubMed database January 24, 2017.

Technology Evaluation Center. (2013, February). Accelerated radiotherapy after breast-conserving surgery for early stage breast cancer. (Vol. 27, No. 6). Retrieved August 5, 2013 from http://www.bcbs.com.

U. S. Food and Drug Administration. (1999, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K983115. Retrieved March 9, 2015 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2004, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K032067. Retrieved October 18, 2011 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2005, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050843. Retrieved February 10, 2015 from http://www.accessdata.fda.gov. 

U. S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070468. Retrieved February 10, 2015 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2008, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081079. Retrieved October 18, 2011 from http://www.accessdata.fda.gov.

Vicini, F., Auther, D. Wazer, D., Chen, P., Mitchell. C., Wallace, M,, et. al. (2011, March) Limitations of the american society of therapeutic radiology and oncology consensus panel guidelines on the use of accelerated partial breast irradiation. International Journal of Radiation Oncology. 2011 Mar 15;79(4):977-84. Abstract retrieved from PubMed database January 24, 2017.

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December). Accelerated partial breast irradiation for breast cancer using brachytherapy. Retrieved January 24, 2017 from www.Hayesinc.com  (72 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December). Brachytherapy as an adjunct to other types of radiation therapy for breast cancer. Retrieved January 24, 2017 from www.Hayesinc.com  (64 articles and/or guidelines reviewed)

Yeo S,G., Kim, J., Kwak, G.H., Kim, J.Y., Park, K., Kim, E.S., et al. (2010). Accelerated partial breast irradiation using multicatheter brachytherapy for the select early-stage breast cancer: local control and toxicity. Radiation Oncology, 5 (56). (Level 3 Evidence - Independent study)

ORIGINAL EFFECTIVE DATE:  12/1/2002

MOST RECENT REVIEW DATE:  3/23/2017

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