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.
OBJECTIVE
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
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).


CONCLUSIONS
Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.
Miller
Robert C
RC
Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA. miller.robert@mayo.edu
Schwartz
David J
DJ
Sloan
Jeff A
JA
Griffin
Patricia C
PC
Deming
Richard L
RL
Anders
Jon C
JC
Stoffel
Thomas J
TJ
Haselow
Robert E
RE
Schaefer
Paul L
PL
Bearden
James D
JD
Atherton
Pamela J
PJ
Loprinzi
Charles L
CL
Martenson
James A
JA
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents; D001943:Breast Neoplasms / Q000532:radiotherapy*; D002278:Carcinoma in Situ / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000532:radiotherapy*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D011855:Radiodermatitis / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate
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