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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