Repeated measures analyses of dermatitis symptom evolution in breast cancer patients receiving radiotherapy in a phase 3 randomized trial of mometasone furoate vs placebo (N06C4 [alliance]).

ABSTRACT:

Purpose

Radiotherapy-related dermatological toxicities over time have not been well quantified. We examined during and immediately following radiation therapy skin toxicities over time in a randomized study of mometasone furoate vs placebo during breast radiotherapy.

Material and methods

Patients with breast cancer undergoing radiotherapy to the breast or chest wall were randomized. Symptoms related to skin toxicity were addressed weekly using provider-reported Common Terminology Criteria for Adverse Events (CTCAE v3.0) and 4 patient-reported outcomes (PRO) surveys. We applied repeated measures and risk analysis methodologies.

Results

One hundred seventy-six patients were enrolled. By CTCAE, significant differences favoring mometasone were detected over time in all to

SUBMITTER: Sio TT 

PROVIDER: S-EPMC4967382 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature