Clinical Policy Bulletin: Radiation Treatment of Keloids
Aetna considers low-dose radiation (superficial or interstitial) medically necessary as an adjunctive therapy immediately following excisional surgery (within 7 days) in the treatment of keloids where medical necessity criteria for keloid removal are met. See CPB 0031 - Cosmetic Surgery for medically necessary indications for keloid removal.
Keloids are benign fibrous growths that arise from proliferation of dermal tissue following skin injury. Conventional treatment options for keloids are occlusive dressings (including silicone-based materials), compression therapy, intra-lesional injections of corticosteroid, cryosurgery, and excision surgery. Newer modalities include the carbon dioxide laser, Nd:YAG laser, argon laser, pulsed dye laser, intra-lesional interferon-gamma and interferon-alfa 2b, and cultured epithelial autografts. In general, laser excision results in similar recurrence rates as conventional surgery. However, the incidence of recurrence is high following conventional forms of treatment. In particular, the recurrence rate of keloids after excision alone has been reported to be between 45 % and 100 %. It has also been reported that the recurrence rate following excision is higher with keloids forming at infected sites and in patients with a family history of keloids. The likelihood of recurrence does not appear to be affected by the person's age, sex, or ethnicity; keloid size or location; individual keloid history; or prior therapy.
Post-operative radiation therapy has been shown to be safe and effective in reducing recurrence of keloids after excision surgery. In addition, it has been reported that post-operative radiation therapy is a simpler treatment modality with better patient compliance than post-operative corticosteroid injections.
Kal and Veen (2005) stated that for successful prevention of recurrence of keloids after surgical excision, a relatively high-dose must be applied in a short overall treatment time. The optimal treatment probably is an irradiation scheme resulting in a biologically effective dose (BED) value of at least 30 Gy. A BED value of 30 Gy can be obtained with, for instance, 1 single acute dose of 13 Gy, 2 fractions of 8 Gy, or 3 fractions of 6 Gy, or 1 single dose of 27 Gy at low-dose rate. The radiation treatment should be administered within 2 days following surgery.
Ogawa and colleagues (2009) noted that keloids are best treated by a combination of surgery and post-operative radiation therapy, although randomized controlled trials testing this are still lacking. However, plastic surgeons tend to avoid radiation therapy for keloids for fear of inducing malignant tumors. Thus, the authors searched for previous reports of associations between carcinogenesis and keloid radiation therapy, and examined the evidence-based opinions of radiation oncologists regarding the acceptability of using radiation to treat keloids. A computerized literature search was carried out using PubMed that included citations from Medline and PubMed Central between 1901 and March of 2009. The following search terms were used: "keloid(s)," "hypertrophic scar(s)," "radiation," "radiation therapy," "radiotherapy," "carcinogenesis," "carcinoma," "cancer," "complications," and "side effects." Moreover, the references for each report were also retrieved. The authors located 5 cases of carcinogenesis (i.e., fibrosarcoma, basal cell carcinoma, thyroid carcinoma, and breast carcinoma) that were associated with radiation therapy for keloids. However, it was unclear if an appropriate dose of radiation was used and whether sufficient protection of surrounding tissues was provided. Moreover, a questionnaire study of radiation oncologists around the world revealed that approximately 80 % considered radiation to be acceptable for treating keloids. The authors concluded that the risk of carcinogenesis attributable to keloid radiation therapy is very low when surrounding tissues, including the thyroid and mammary glands, especially in children and infants, are adequately protected, and that radiation therapy is acceptable as a keloid treatment modality.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
ICD-9 codes covered if selection criteria are met:
The above policy is based on the following references:
Tisdale BA. When to consider radiation therapy for your patients. Am Fam Physician. 1999;59(5):1177-1184.
English RS, Shenefelt PD. Keloids and hypertrophic scars. Dermatol Surg. 1999;25(8):631-638.
Ogawa R, Mitsuhashi K, Hyakusoku H, Miyashita T. Postoperative electron-beam irradiation therapy for keloids and hypertrophic scars: Retrospective study of 147 cases followed for more than 18 months. Plast Reconstr Surg. 2003;111(2):547-553; discussion 554-555.
Thom GA, Heywood JM, Cassidy B, Freund JM. Three-year retrospective review of superficial radiotherapy for skin conditions in a Perth radiotherapy unit. Australas J Dermatol. 2003;44(3):174-179.
Dinh Q, Veness M, Richards S. Role of adjuvant radiotherapy in recurrent earlobe keloids. Australas J Dermatol. 2004;45(3):162-166.
Malaker K, Vijayraghavan K, Hodson I, Al Yafi T. Retrospective analysis of treatment of unresectable keloids with primary radiation over 25 years. Clin Oncol (R Coll Radiol). 2004;16(4):290-298.
UK National Health Service (NHS), National Library for Health (NLH). What is the recommended management of cheloid scars? Primary Care Question Answering Service. London, UK: NLH; February 28, 2005. Available at: http://www.clinicalanswers.nhs.uk/index.cfm?question=259. Accessed August 22, 2005.
Kal HB, Veen RE. Biologically effective doses of postoperative radiotherapy in the prevention of keloids. Dose-effect relationship. Strahlenther Onkol. 2005;181(11):717-723.
Al-Attar A, Mess S, Thomassen JM, Keloid pathogenesis and treatment. Plast Reconstr Surg. 2006;117(1):286-300.
Jones K, Fuller CD, Luh JY, et al. Case report and summary of literature: Giant perineal keloids treated with post-excisional radiotherapy. BMC Dermatol. 2006;6:7.
De Lorenzi F, Tielemans HJ, van der Hulst RR, et al. Is the treatment of keloid scars still a challenge in 2006? Ann Plast Surg. 2007;58(2):186-192.
van de Kar AL, Kreulen M, van Zuijlen PP, Oldenburger F. The results of surgical excision and adjuvant irradiation for therapy-resistant keloids: A prospective clinical outcome study. Plast Reconstr Surg. 2007;119(7):2248-2254.
Ogawa R, Miyashita T, Hyakusoku H, et al. Postoperative radiation protocol for keloids and hypertrophic scars: Statistical analysis of 370 sites followed for over 18 months. Ann Plast Surg. 2007;59(6):688-691.
Speranza G, Sultanem K, Muanza T. Descriptive study of patients receiving excision and radiotherapy for keloids. Int J Radiat Oncol Biol Phys. 2008;71(5):1465-1469.
Viani GA, Stefano EJ, Afonso SL, De Fendi LI. Postoperative strontium-90 brachytherapy in the prevention of keloids: Results and prognostic factors. Int J Radiat Oncol Biol Phys. 2009;73(5):1510-1516.
Sakamoto T, Oya N, Shibuya K, et al. Dose-response relationship and dose optimization in radiotherapy of postoperative keloids. Radiother Oncol. 2009;91(2):271-276.
Ogawa R, Yoshitatsu S, Yoshida K, Miyashita T. Is radiation therapy for keloids acceptable? The risk of radiation-induced carcinogenesis. Plast Reconstr Surg. 2009;124(4):1196-1201.
Stahl S, Barnea Y, Weiss J, et al. Treatment of earlobe keloids by extralesional excision combined with preoperative and postoperative "sandwich" radiotherapy. Plast Reconstr Surg. 2010;125(1):135-141.
Flickinger JC. A radiobiological analysis of multicenter data for postoperative keloid radiotherapy. Int J Radiat Oncol Biol Phys. 2011;79(4):1164-1170.
Yamawaki S, Naitoh M, Ishiko T, et al. Keloids can be forced into remission with surgical excision and radiation, followed by adjuvant therapy. Ann Plast Surg. 2011;67(4):402-406.
Pai VB, Cummings I. Are there any good treatments for keloid scarring after sternotomy? Interact Cardiovasc Thorac Surg. 2011;13(4):415-418.
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