A randomized trial of mometasone furoate 0.1% to reduce high-grade acute radiation dermatitis in breast cancer patients receiving postmastectomy radiation Journal Article


Authors: Ho, A. Y.; Olm-Shipman, M.; Zhang, Z.; Siu, C. T.; Wilgucki, M.; Phung, A.; Arnold, B. B.; Porinchak, M.; Lacouture, M.; McCormick, B.; Powell, S. N.; Gelblum, D. Y.; Cahlon, O.
Article Title: A randomized trial of mometasone furoate 0.1% to reduce high-grade acute radiation dermatitis in breast cancer patients receiving postmastectomy radiation
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 receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream. © 2018
Keywords: adult; cancer chemotherapy; controlled study; aged; major clinical study; intensity modulated radiation therapy; doxorubicin; fluorouracil; skin toxicity; cancer radiotherapy; radiation dose; methotrexate; cancer staging; cancer diagnosis; cancer incidence; quality of life; breast cancer; randomized controlled trial; radiotherapy; cyclophosphamide; docetaxel; body mass; body mass index; disease severity; photons; trastuzumab; randomized trial; diseases; radiation dermatitis; desquamation; conformal radiotherapy; radical mastectomy; adverse events; common terminology criteria; patient-reported outcome; intensity-modulated; mometasone furoate; human; female; priority journal; article
Journal Title: International Journal of Radiation Oncology, Biology, Physics
Volume: 101
Issue: 2
ISSN: 0360-3016
Publisher: Elsevier Inc.  
Date Published: 2018-06-01
Start Page: 325
End Page: 333
Language: English
DOI: 10.1016/j.ijrobp.2018.02.006
PROVIDER: scopus
PUBMED: 29726361
DOI/URL:
Notes: Article -- Erratum to the author list issued, see DOI: 10.1016/j.ijrobp.2018.05.050 -- Export Date: 1 June 2018 -- Source: Scopus
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MSK Authors
  1. Alice Yoosun Ho
    109 Ho
  2. Zhigang Zhang
    237 Zhang
  3. Simon Nicholas Powell
    163 Powell
  4. Mario E Lacouture
    248 Lacouture
  5. Daphna Y Gelblum
    78 Gelblum
  6. Oren Cahlon
    82 Cahlon
  7. Beryl McCormick
    243 McCormick
  8. Brittany Berasi Arnold
    5 Arnold
  9. Chun Ting Siu
    15 Siu
  10. Anh Xuan Phung
    3 Phung