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])
| Autor: | Charles L. Loprinzi, Drew K. Seisler, Patricia C. Griffin, Michelle A. Neben Wittich, Jeff A. Sloan, Robert C. Miller, David Schwartz, Brandon Birckhead, James D. Bearden, Rex B. Mowat, Robert E. Haselow, Pamela J. Atherton, James A. Martenson, Roscoe F. Morton, Jon C. Anders, Thomas J. Stoffel, Terence T. Sio |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
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 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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