A Randomized Trial of Mometasone Furoate 0.1% to Reduce High-Grade Acute Radiation Dermatitis in Breast Cancer Patients Receiving Postmastectomy Radiation

被引:60
|
作者
Ho, Alice Y. [1 ]
Olm-Shipman, Molly [2 ]
Zhang, Zhigang [3 ]
Siu, Chun Ting [4 ]
Wilgucki, Molly [4 ]
Phung, Anh [4 ]
Arnold, Brittany B. [1 ]
Porinchak, Marypat [5 ]
Lacouture, Mario [6 ]
McCormick, Beryl [4 ]
Powell, Simon N. [4 ]
Gelblum, Daphna Y. [4 ]
机构
[1] Massachusetts Gen Hosp, Dept Radiat Oncol, Boston, MA 02114 USA
[2] Univ Colorado Hlth, Dept Oncol Access, Aurora, CO USA
[3] Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, New York, NY 10021 USA
[4] Mem Sloan Kettering Canc Ctr, Dept Radiat Oncol, 1275 York Ave, New York, NY 10021 USA
[5] Mem Sloan Kettering Canc Ctr, Dept Nursing, 1275 York Ave, New York, NY 10021 USA
[6] Mem Sloan Kettering Canc Ctr, Dept Med, Dermatol Serv, New York, NY 10021 USA
来源
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2018年 / 101卷 / 02期
关键词
QUALITY-OF-LIFE; INDUCED SKIN TOXICITY; DOUBLE-BLIND; PHASE-III; PROPHYLACTIC AGENT; RADIOTHERAPY; THERAPY; CREAM; PREVENTION; INSTRUMENTS;
D O I
10.1016/j.ijrobp.2018.02.006
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. Published by Elsevier Inc.
引用
收藏
页码:325 / 333
页数:9
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