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

Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):81-6. doi: 10.1016/s0360-3016(01)01576-0.

Abstract

Purpose: To assess the efficacy of Biafine cream in preventing Grade 2 acute radiation dermatitis, according to the National Cancer Institute of Canada skin radiation toxicity criteria in patients undergoing concomitant adjuvant 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 radiotherapy to the breast. Biafine cream was applied daily, starting on the first day and ending 2 weeks post-radiotherapy. Patients underwent weekly skin 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 radiation 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 majority of the radiation dermatitis was observed after 3 weeks of radiotherapy.

Conclusion: The majority of patients who underwent concomitant chemo- and radiotherapy for breast cancer developed Grade 2 radiation dermatitis with the use of Biafine cream. However, no treatment delays or interruptions were observed because of skin toxicity.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / radiotherapy*
  • Breast Neoplasms / surgery
  • Chemotherapy, Adjuvant
  • Dermatologic Agents / therapeutic use*
  • Emulsions
  • Female
  • Humans
  • Lipids*
  • Mastectomy, Segmental
  • Middle Aged
  • Outcome Assessment, Health Care
  • Radiodermatitis / pathology
  • Radiodermatitis / prevention & control*
  • Silver Sulfadiazine / adverse effects
  • Silver Sulfadiazine / therapeutic use
  • Surveys and Questionnaires

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Biafine
  • Dermatologic Agents
  • Emulsions
  • Lipids
  • Silver Sulfadiazine