Fisher, J., Scott, C., Stevens, R., Marconi, B., Champion, L., Freedman, G. M., … Wong, G. (2000). Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97–13. International Journal of Radiation Oncology, Biology, Physics, 48, 1307–1310.

DOI Link

Study Purpose

To determine if Biafine was more effective than best supportive care (BSC) in preventing or reducing radiation (RT)-induced dermatitis.

Intervention Characteristics/Basic Study Process

Randomizaton to Biafine versus BSC depended on the institution and included aloe, Aquaphor, other interventions, and no treatment.

Patients were stratified by bra size:  small (32ab, 34ab, 36a), medium (32c, 34c, 36bc, 38abc), or large (all others).

Sample Characteristics

  • The sample was comprised of 172 women.
  • Median age was 62 years for both groups.
  • Patients had breast cancer and were not undergoing chemotherapy.
  • Dose was 50 to 59 cGy versus 59 to 64 cGy.

Setting

  • Dearborn, Michigan
  • Philadelphia, Pennsylvania
  • White Plains, New York
  • Newark, Delaware
  • San Francisco, California
  • Baltimore, Maryland
  • Ann Arbor, Michigan
  • Joliet, Illinois
  • Albuquerque, New Mexico

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) toxicity scale weekly and at two and six weeks after RT
  • Maximum toxicity was determined to be the worst skin toxicity observed.
  • Weekly completion of the Spitzer QOL questionnaire and patient satisfaction

Results

  • There was no overall difference in maximum toxicity between the treatment arms during RT.
  • No statistical difference was found between arms in the time grade 2 toxicity.
  • All had resolution by week 9.
  • Large breasted women receiving Biafine were more likely to have no toxicity week 6 after RT (p = 0.002).
  • There was an interaction with treatment healing and tobacco use. Smokers in the Biafine arm had 26% no toxicity in follow-up, and smokers in BSC had 57% no toxicity in follow-up (p = 0.06). Those who never smoked and received Biafine had no skin toxicities at 6-week follow-up (p = 0.026).

Limitations

  • Rater bias occurred.
  • The authors did not state who rated the patients and what training occurred.
  • The authors did not state if patients were checked the same day every week or at the beginning of each patient week.
  • The authors did not record what the application technique was and if it was the same across the different institutions.