A Randomized Trial of Mometasone Furoate 0.1% to Reduce High-Grade Acute Radiation Dermatitis in Breast Cancer Patients Receiving Postmastectomy Radiation
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)....
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Published in | International journal of radiation oncology, biology, physics Vol. 101; no. 2; pp. 325 - 333 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Elsevier Inc
01.06.2018
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Abstract | 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).
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.
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.
Breast cancer patients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. |
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AbstractList | 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).
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.
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.
Breast cancer patients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. 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). |
Author | Powell, Simon N. Porinchak, Marypat Siu, Chun Ting Zhang, Zhigang Wilgucki, Molly Phung, Anh Lacouture, Mario Ho, Alice Y. Gelblum, Daphna Y. Arnold, Brittany B. Olm-Shipman, Molly McCormick, Beryl |
Author_xml | – sequence: 1 givenname: Alice Y. surname: Ho fullname: Ho, Alice Y. email: Alice.Ho@mgh.harvard.edu organization: Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA – sequence: 2 givenname: Molly surname: Olm-Shipman fullname: Olm-Shipman, Molly organization: Department of Oncology Access, University of Colorado Health, Aurora, Colorado – sequence: 3 givenname: Zhigang surname: Zhang fullname: Zhang, Zhigang organization: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 4 givenname: Chun Ting surname: Siu fullname: Siu, Chun Ting organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 5 givenname: Molly surname: Wilgucki fullname: Wilgucki, Molly organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 6 givenname: Anh surname: Phung fullname: Phung, Anh organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 7 givenname: Brittany B. surname: Arnold fullname: Arnold, Brittany B. organization: Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA – sequence: 8 givenname: Marypat surname: Porinchak fullname: Porinchak, Marypat organization: Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 9 givenname: Mario surname: Lacouture fullname: Lacouture, Mario organization: Department of Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 10 givenname: Beryl surname: McCormick fullname: McCormick, Beryl organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 11 givenname: Simon N. surname: Powell fullname: Powell, Simon N. organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York – sequence: 12 givenname: Daphna Y. surname: Gelblum fullname: Gelblum, Daphna Y. organization: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York |
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SubjectTerms | Acute Disease Adult Aged Aged, 80 and over Breast Neoplasms - pathology Breast Neoplasms - radiotherapy Breast Neoplasms - surgery DERMATITIS Dermatologic Agents - administration & dosage Dermatologic Agents - therapeutic use Double-Blind Method Female Humans Lipids - administration & dosage Lipids - therapeutic use MAMMARY GLANDS Mastectomy Middle Aged Mometasone Furoate - administration & dosage Mometasone Furoate - therapeutic use NEOPLASMS Ointment Bases - administration & dosage Ointment Bases - therapeutic use PATIENTS Postoperative Care Quality of Life Radiodermatitis - pathology Radiodermatitis - prevention & control RADIOLOGY AND NUCLEAR MEDICINE Thoracic Wall - radiation effects Treatment Outcome |
Title | A Randomized Trial of Mometasone Furoate 0.1% to Reduce High-Grade Acute Radiation Dermatitis in Breast Cancer Patients Receiving Postmastectomy Radiation |
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