Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial From the North Central Cancer Treatment Group N06C4

Journal Article · Fri Apr 01 00:00:00 EDT 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2010.01.031· OSTI ID:21491686

Schwartz, David J ^[1]; Sloan, Jeff A ^[2]; Griffin, Patricia C ^[3]; Deming, Richard L ^[4]; Anders, Jon C ^[5]; Stoffel, Thomas J ^[6]; Haselow, Robert E ^[7]; Schaefer, Paul L ^[8]; Bearden, James D ^[3]; Atherton, Pamela J ^[2]; Loprinzi, Charles L; Martenson, James A ^[9]

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1. Minneapolis Radiation Oncology, P.A., Minneapolis, MN (United States)
2. Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, MN (United States)
3. Upstate Carolina Community Clinic Oncology Program, Spartanburg, SC (United States)
4. Iowa Oncology Research Association Community Clinic Oncology Program, Des Moines, Iowa (United States)
5. Wichita Community Clinical Oncology Program, Wichita, KS (United States)
6. Cedar Rapids Oncology Project Community Clinic Oncology Program, Cedar Rapids, IA (United States)
7. Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, MN (United States)
8. Toledo Community Hospital Oncology Program Community Clinic Oncology Program, Toledo, OH (United States)
9. Department of Radiation Oncology, Mayo Clinic, Rochester, MN (United States)

Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

• OSTI ID: 21491686
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 79, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2010.01.031; PII: S0360-3016(10)00131-8; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CARCINOMAS
CHEST
GLUCOCORTICOIDS
MAMMARY GLANDS
RADIODERMATITIS
RADIOTHERAPY
SKIN
TOXICITY
ADRENAL HORMONES
BIOLOGICAL EFFECTS
BIOLOGICAL RADIATION EFFECTS
BODY
CORTICOSTEROIDS
DERMATITIS
DISEASES
GLANDS
HORMONES
HYDROXY COMPOUNDS
INJURIES
KETONES
LOCAL RADIATION EFFECTS
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANS
PREGNANES
RADIATION EFFECTS
RADIATION INJURIES
RADIOLOGY
SKIN DISEASES
STEROID HORMONES
STEROIDS
THERAPY