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
| Autor: | Jeff A. Sloan, Robert C. Miller, James D. Bearden, Charles L. Loprinzi, Patricia C. Griffin, Paul L. Schaefer, David Schwartz, Jon C. Anders, Thomas J. Stoffel, Richard L. Deming, Robert E. Haselow, Pamela J. Atherton, James A. Martenson |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty medicine.medical_treatment Anti-Inflammatory Agents Mometasone furoate Breast Neoplasms Placebo Article Breast cancer Double-Blind Method Internal medicine Clinical endpoint Medicine Humans Radiology Nuclear Medicine and imaging External beam radiotherapy Adverse effect Pregnadienediols Aged Aged 80 and over Radiation business.industry Pruritus Carcinoma Ductal Breast Common Terminology Criteria for Adverse Events Middle Aged medicine.disease Surgery Oncology Acute Disease Female Dermatologic Agents Skin cancer Radiodermatitis business Mometasone Furoate Carcinoma in Situ medicine.drug |
| Zdroj: | International journal of radiation oncology, biology, physics. 79(5) |
| ISSN: | 1879-355X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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