Alice Y Ho1, Molly Olm-Shipman2, Zhigang Zhang3, Chun Ting Siu4, Molly Wilgucki4, Anh Phung4, Brittany B Arnold5, Marypat Porinchak6, Mario Lacouture7, Beryl McCormick4, Simon N Powell4, Daphna Y Gelblum4. 1. Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA. Electronic address: Alice.Ho@mgh.harvard.edu. 2. Department of Oncology Access, University of Colorado Health, Aurora, Colorado. 3. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York. 4. Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. 5. Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA. 6. Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, New York. 7. Department of Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Abstract
PURPOSE: A 2-arm, double-blinded randomized trial was conducted to evaluate the efficacy of 0.1% mometasone furoate (MF) versus Eucerin Original (E) cream in preventing the development of moderate to severe acute radiation dermatitis (ARD) in breast cancer patients receiving postmastectomy radiation (PMRT). METHODS:Breast cancer patients undergoing chest wall with or without nodal radiation therapy (RT) (50 Gy) were eligible. Randomization (1:1) was to MF or E, applied twice daily from day 1 of PMRT to 14 days after PMRT. Patients were stratified by RT technique, body mass index, and reconstruction status. Daily bolus of 3 to 10 mm was applied in all patients. The primary endpoint was the development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03) ARD with moist desquamation or any grade ≥3 dermatitis. Secondary endpoints were time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16. Assessments were performed at baseline, weekly during PMRT, and 2 weeks after PMRT. RESULTS:124 patients were enrolled between May 2013 and February 2016. Of those, 35% had pathologic stage III disease, 6% had cT4d disease, and 68% underwent reconstruction. Sixty percent received 3-dimensional conformal RT with photons only to the chest wall, 18% received electrons and photons, and 23% received inverse-planned intensity modulated RT. Groups were well balanced for age, skin type, and stage. The rate of moist desquamation was 54.8% in the entire cohort, with a significantly reduced incidence in the MF arm than in the E arm (43.8% vs 66.7%; P = .012). The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001). There was no difference in patient-reported skin outcomes between arms. CONCLUSIONS:Breast cancer patients receivingMF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. Published by Elsevier Inc.
RCT Entities:
PURPOSE: A 2-arm, double-blinded randomized trial was conducted to evaluate the efficacy of 0.1% mometasone furoate (MF) versus Eucerin Original (E) cream in preventing the development of moderate to severe acute radiation dermatitis (ARD) in breast cancerpatients receiving postmastectomy radiation (PMRT). METHODS:Breast cancerpatients undergoing chest wall with or without nodal radiation therapy (RT) (50 Gy) were eligible. Randomization (1:1) was to MF or E, applied twice daily from day 1 of PMRT to 14 days after PMRT. Patients were stratified by RT technique, body mass index, and reconstruction status. Daily bolus of 3 to 10 mm was applied in all patients. The primary endpoint was the development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03) ARD with moist desquamation or any grade ≥3 dermatitis. Secondary endpoints were time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16. Assessments were performed at baseline, weekly during PMRT, and 2 weeks after PMRT. RESULTS: 124 patients were enrolled between May 2013 and February 2016. Of those, 35% had pathologic stage III disease, 6% had cT4d disease, and 68% underwent reconstruction. Sixty percent received 3-dimensional conformal RT with photons only to the chest wall, 18% received electrons and photons, and 23% received inverse-planned intensity modulated RT. Groups were well balanced for age, skin type, and stage. The rate of moist desquamation was 54.8% in the entire cohort, with a significantly reduced incidence in the MF arm than in the E arm (43.8% vs 66.7%; P = .012). The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001). There was no difference in patient-reported skin outcomes between arms. CONCLUSIONS:Breast cancerpatients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. Published by Elsevier Inc.
Authors: Andrea L DiCarlo; Aaron C Bandremer; Brynn A Hollingsworth; Suhail Kasim; Adebayo Laniyonu; Nushin F Todd; Sue-Jane Wang; Ellen R Wertheimer; Carmen I Rios Journal: Radiat Res Date: 2020-09-16 Impact factor: 2.841
Authors: Julie Ryan Wolf; Jennifer S Gewandter; Javier Bautista; Charles E Heckler; Jon Strasser; Pawal Dyk; Thomas Anderson; Howard Gross; Tod Speer; Lindsey Dolohanty; Kevin Bylund; Alice P Pentland; Gary R Morrow Journal: Support Care Cancer Date: 2019-11-22 Impact factor: 3.603