Phase II study assessing the effectiveness of biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy

Purpose: To assess the efficacy of Biafine cream in preventing Grade 2 acut e radiation dermatitis, according to The National Cancer Institute of Canad a skin radiation toxicity criteria in patients undergoing concomitant adjuv ant chemotherapy and radiotherapy to the breast. Methods and Materials: Sixty patients participated in this study. Patients were treated with a lumpectomy followed by concomitant chemotherapy and rad iotherapy to the breast. Biafine cream was applied daily, starting on the f irst day and ending 2 weeks post-radiotherapy. Patients underwent weekly sk in assessments throughout radiotherapy and at 2 and 4 weeks after treatment . Outcome measures were assessed using a Skin Assessment Questionnaire that was scored according to the National Cancer Institute of Canada skin radia tion toxicity criteria and a self-administered questionnaire that evaluated skin symptoms. Results: The maximum skin toxicity observed during the course of treatment was as follows: less than Grade 2 toxicity, 15% (9 patients); Grade 2, 83% (50 patients); Grade 3, 2% (1 patient); Grade 4, 0% (0 patients). The major ity of the radiation dermatitis was observed after 3 weeks of radiotherapy. Conclusion: The majority of patients who underwent concomitant chemo- and r adiotherapy for breast cancer developed Grade 2 radiation dermatitis with t he use of Biafine cream. However, no treatment delays or interruptions were observed because of skin toxicity. (C) 2001 Elsevier Science Inc.