Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA, et al.
International journal of radiation oncology, biology, physics. Date of publication 2011 Apr 1;volume 79(5):1460-6.
1. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1460-6. doi:
10.1016/j.ijrobp.2010.01.031. Epub 2010 Aug 26.
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.
Miller RC(1), Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel
TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson
JA.
Author information:
(1)Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.
miller.robert@mayo.edu
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.
Copyright © 2011 Elsevier Inc. All rights reserved.
DOI: 10.1016/j.ijrobp.2010.01.031
PMCID: PMC2995007
PMID: 20800381 [Indexed for MEDLINE]
