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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])
- Publication Year :
- 2016
-
Abstract
- 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. 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. One hundred seventy-six patients were enrolled. By CTCAE, significant differences favoring mometasone were detected over time in all toxicities except skin striae, atrophy, and infection. Statistically significant differences between arms at baseline but not over time occurred for all Linear Analog Self-Assessment. Statistically significant differences occurred for all symptoms in the temporal profile of symptoms as measured by PRO surveys (all P
- Subjects :
- medicine.medical_specialty
Pathology
medicine.medical_treatment
Mometasone furoate
Breast Neoplasms
Placebo
Article
law.invention
03 medical and health sciences
0302 clinical medicine
Breast cancer
Randomized controlled trial
law
Risk Factors
Internal medicine
medicine
Humans
030212 general & internal medicine
Patient Reported Outcome Measures
Aged
business.industry
Repeated measures design
Common Terminology Criteria for Adverse Events
Middle Aged
medicine.disease
Clinical trial
Radiation therapy
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Female
business
Mometasone Furoate
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....d298f8f4aa1da4b823dde8d4a01d8383