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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.

AbstractPURPOSE:
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.
AuthorsE Szumacher, A Wighton, E Franssen, E Chow, M Tsao, I Ackerman, L Andersson, J Kim, A Wojcicka, Y Ung, K Sixel, C Hayter
JournalInternational journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 51 Issue 1 Pg. 81-6 (Sep 01 2001) ISSN: 0360-3016 [Print] United States
PMID11516855 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Biafine
  • Dermatologic Agents
  • Emulsions
  • Lipids
  • Silver Sulfadiazine
Topics
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Breast Neoplasms (drug therapy, radiotherapy, surgery)
  • Chemotherapy, Adjuvant
  • Dermatologic Agents (therapeutic use)
  • Emulsions
  • Female
  • Humans
  • Lipids
  • Mastectomy, Segmental
  • Middle Aged
  • Outcome Assessment, Health Care
  • Radiodermatitis (pathology, prevention & control)
  • Silver Sulfadiazine (adverse effects, therapeutic use)
  • Surveys and Questionnaires

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