Szumacher, E., Wighton, A., Franssen, E., Chow, E., Tsao, M., Ackerman, I., … Hayter, C. (2001). 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. International Journal of Radiation Oncology, Biology, Physics, 51, 81–86.

To assess the efficacy of Biafine cream in preventing grade 2 acute radiodermatitis.

• Biafine cream was applied twice daily to the skin within the treatment field, starting on first day of radiation therapy (RT) treatment and ending two weeks after RT.
• No application of ointment within four hours prior to RT was allowed.
• No other prophylactic agents were to be applied to the RT field during the course of RT.
• Application of ointment was permitted within four hours before RT.
• Patients were given general skin care recommendations at the start of RT.
• Patients who developed grade 2 radiodermatitis had the option to withdraw from study and be treated with other topical agents or to continue with Biafine cream.

• The sample was comprised of 60 women.
• Median age was 49 years (range 25–77).
• Patients had breast cancer and were treated with lumpectomy.
• Treatment lasted for five weeks, with a total dose of 5,000 cGy in 200 cGy fractions and no boost.
• Patients were treated on a 6-mv photon accelerator.
• All patients wer treated with concomitant adjuvant chemotherapy.

Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

Skin within the RT field was examined before the initiation of RT, at weekly intervals, and at two and four weeks after treatment by a radiation oncologist or a dedicated radiation technologist.

The Skin Assessment Questionnaire was scored according to the National Cancer Institute of Canada skin radiation toxicity criteria.

The self-administered questionnaire incorporated items from the instrument developed for the Ontario Clinical Oncology Group trial of hypofractionated RT after lumpectomy in women with node-negative breast cancer.

The study was an exploratory, phase II, intervention trial.

• Maximum skin toxicity observed during the five-week course of treatment was:
  • Less than grade 2 toxicity (15%; n = 9)
  • Grade 2 (83%; n = 50)
  • Grade 3 (2%; n = 1)
  • Grade 4 (0%; n = 0).
• The majority of dermatitis was observed after three weeks of RT.
• Eight patients started Flamazine™ (Smith & Nephew, Inc.) cream with grade 2 desquamation.
• Most patients subjectively felt that Biafine cream was soothing.
• No treatment delays or interruptions were observed due to skin toxicity.

The majority of patients who underwent concomitant chemotherapy and RT for breast cancer developed grade 2 radiodermatitis with the use of Biafine cream.

• There was a wide range of RT start times from the start of chemotherapy.
• It was not possible to compare to a control group to determine comparative effects.