Superficial Radiation Thera Superficial Radiation Therapy py (SRT) in the Treatment of Keloids (SRT) in the Treatment of Keloids Brian Berman, M.D., Ph.D. Brian Berman, M.D., Ph.D. Center for Clinical and Cosmetic Research & University of Miami School of Medicine
Disclosure of Industry Relationships Disclosure of Industry Relationships Radiation Treatment of Keloids Radiation Treatment of Keloids - Brian Berman, MD, PhD Brian Berman, MD, PhD Biofrontera Advisory Board Honoraria Aiviva Biopharma Consultant Honoraria Pulse Biosciences Consultant Honoraria Celumigen Consultant Stock Options Dermira Advisory Board & Consultant Stock Options Dr. Tattoff Advisory Board Stock Options DUSA Pharmaceuticals, Inc Advisory Board & Consultant Honoraria Exeltis Consultant & Investigator Honoraria Ferndale Laboratories, Inc. Consultant Honoraria Galderma Laboratories, L.P. Advisory Board Honoraria GlaxoSmithKline Consultant Honoraria Self Halscion Advisory Board Honoraria & Stock Options Klara/Goderma, Inc. Consultant Stock Options LEO Pharma, US Speaker, Advisory Board & Investigator Honoraria Medimetriks Pharmaceuticals, Inc. Consultant Honoraria Miragen Consultant Honoraria Sirnaomics, Consultant Honoraria Novan Consultant Honoraria Novartis Pharmaceuticals Corp. Advisory Board & Speaker Honoraria Oculus Innovative Sciences, Inc. Consultant Stock Options SensusSpeaker and Consultant Honoraria Smith & Nephew Advisory Board Honoraria Pierre Fabre Consultant Honoraria TopMD Advisory Board Stock Valeant Pharmaceuticals International Speaker & Advsory Board Aclaris Consultant Honoraria
Keloid Recurrence Rates Keloid Recurrence Rates Weighted Average Recurrence = 71.2 % Weighted Average Recurrence = 71.2 %
Post Post-Excision Excision Radiation and Ke Radiation and Keloid loid Recurrences Recurrences
X-Ray Radiation in the Ray Radiation in the Electromagnetic Spectrum Electromagnetic Spectrum
DNA / RNA Damage due to DNA / RNA Damage due to Ionizing Radiation Ionizing Radiation
Ionizing Radiation on Wound Healing Ionizing Radiation on Wound Healing Full-thickness, 2-cm-diameter, dorsal rat skin, with and without prior local irradiation with 521 rad, was excised Control wounds Control wounds contained: prominent BrdU-positive proliferating cells , at days 3 -9 & minimal TUNEL-positive apoptotic cells during healing Irradiated wounds Irradiated wounds had: fewer fewer BrdU-positive proliferating cells proliferating cells and significant significant TUNEL-positive apoptotic cells apoptotic cells at days 3 -9, & persistent lower lower proportion of G2/M G2/M phase cells Radiation-induced inactive cell proliferation inactive cell proliferation , greater greater apoptosis apoptosis , and cell cycle arrest cell cycle arrest at days 3-9 post-wounding may be cellular mechanisms responsible for delayed wound delayed wound healing healing Liu, X et al. J Trauma. 2005 Sep;59(3):682-90.
Post Post-Excision Radiation & Keloids Excision Radiation & Keloids In a retrospective study retrospective study of 80 80 keloidectomy keloidectomy patients treated with postoperative postoperative single-fraction 10Gy radiotherapy radiotherapy 9% 9% of keloids relapsed after 1 year 16% 16% of keloids relapsed after 5 years RagoowansiR, Cornes PG, Moss AL, Glees JP. Plast Reconstruct Surg 2003; 111: 1853 –9.
Post Post-Excision Radiation of Auricular Kelo Excision Radiation of Auricular Keloids ids Relapse-Free Rate Following Relapse Free Rate Following Post-Operative Radiotherapy (n=76) Post Operative Radiotherapy (n=76) Retrospective study of suturing lines of 60 Retrospective study 60 keloidectomy keloidectomy patients ( 76 76 ear ear keloids keloids ) Treated 1-3 days post post-operatively operatively with 5 Gy/wk, 25-45 Gy total dose, contact or superficial radiotherapy radiotherapy 3 Years 3 Years BL BL 5 year year relapse relapse -free free rate of 79.84% 79.84% No pigmentation or telangiectasias No pigmentation or telangiectasias Recalcati S et al. J Dermatol Treatment 2011; 22: 38 -42
Superficial Radiation Therapy Superficial Radiation Therapy for the for the Prevention of Prevention of Keloids Keloids After Surgery After Surgery A BED value of 30 Gy can be obtained with –a single acute dose of 13 Gy –two fractions of 8 Gy –three fractions of 6 three fractions of 6 Gy Gy –a single dose of 27 Gy at low dose rate The radiation treatment should be administered within 1-2 days after surgery Kal HB, Veen RE . Keloid Dose and Fractionation Schemes
Keloidectomy Keloidectomy + BED 30 SRT + BED 30 SRT 297 297 keloids were surgically completely excised Starting on post-operative day 1 the suture closure line, with a 5 mm margin, received a BED 30 of superficial radiation 70 or 100 kV Almost all, three 6 Gy fractions on POD 1, 2 & 3 Follow-up: 3m to >3 yrs (majority >6m) 9/297 9/297 recurrences recurrences (3.0% 3.0% ) ) Berman et al. SKIN 2: 402, 2018
SRT (BED 30) Post SRT (BED 30) Post-Keloidectomy Keloidectomy BL Post BL Post-Excision Excision 6 m 12 m 6 m 12 m Schmieder, EADV Geneva, 2017
SRT ports for large keloid SRT ports for large keloid excision site treatment excision site treatment 18 cm x 8 cm 12.7 cm diameter at 30 cm SSD at 25 cm SSD
Keloidectomy Keloidectomy + BED 30 SRT: + BED 30 SRT: Chart Review Chart Review Retrospective, chart review study of 96 96 excised keloids + SRT (61 patients) with > 1 year 1 year followup followup (or recurrence noted prior to 1 year), at 4 US sites Usually 3, 6-Gy fractions, on POD 1, 2 & 3 (BED 30 SRT 70 or 100 kV) to the suture closure line, with a 5 mm margin 10 10 /96, 10.4% 10.4% treated keloids noted to recur within 12 12 months - 5/10 5/10 were clinically significant; 1 additional recurrence by 18 18 months f/u 8/11 recurred within the first 6 months; 2/11 within 6 to 12 months and 1/11 within 12 to 18 months; Kaplan-Meier Survival Probability Estimate cure rate cure rate of 85.6% 85.6% from 24 months 24 months post-SRT treatment end onwards onwards Greater rate of recurrence if keloid had previously recurred or was on chest If 1 recurred, not all keloids recurred in patients with multiple treated keloids
Clinically Significant Recurrence Clinically Significant Recurrence Non-Clinically Significant Recurrence Non Clinically Significant Recurrence Prior to Excision and SRT (left) and Prior to Excision and SRT (left) and Prior to Excision/SRT (left) and Prior to Excision/SRT (left) and 6-month follow month follow -up Post up Post-SRT (right) SRT (right) 19 months Post-SRT (right) 19 months Post SRT (right) Silicon scar gel was recommended at Silicon scar gel was recommended at Patient received an intralesional Patient received an intralesional the 6 the 6-month follow month follow -up visit up visit corticosteroid and topical silicone gel at corticosteroid and topical silicone gel at the last follow the last follow -up visit up visit
Consensus Guidelines on the Use Consensus Guidelines on the Use of of Superficial Radiation Therapy for T Superficial Radiation Therapy for Treating reating Nonmelanoma Skin Cancers and Ke Nonmelanoma Skin Cancers and Keloids loids 11.1 …Post-surgical treatment of keloid excision suture lines with several fractions of SRT significantly reduces keloid recurrence rates. … 11.2 …Fractionation of the SRT dose reduces the risk of hyperpigmentation and other adverse events . The optimal treatment protocol is a biologically effective dose of 3000 cGy in three fractions of 600 cGy on post-operative days 1, 2 and 3. … 11.3 There is little evidence that exposing keloid or surrounding healthy skin to SRT at a 3000 cGy dosing causes skin cancer. Nestor, Berman, Goldberg, Cognetta, Gold, Roth, Cockerell , Glick: J Clin Aesthet Dermatol. 2019;12(2):12–18
Radiation Treatment of Keloids Literature Radiation Treatment of Keloids Literature Review for Associated Malignancy Review for Associated Malignancy A computerized literature search of MEDLINE and PubMed Central between 1901 and March of 2009 located 5 cases of carcinogenesis that were associated with radiation therapy for keloids Basal cell carcinoma, thyroid carcinoma, breast carcinoma and fibrosarcoma However, it was unclear whether an appropriate dose of radiation or sufficient protection were used The authors conclude radiation therapy is acceptable as a keloid treatment modality Ogawa et al. Plast Reconstr Surg. 2009 Oct;124(4):1196 -201
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