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.

Abstract

PURPOSE:

To determine if Biafine compared to Best Supportive Care (BSC) is effective in minimizing or preventing radiation-induced dermatitis in women undergoing breast irradiation.

METHODS AND MATERIALS:

Patients were randomized between Biafine (n = 83) vs. BSC (n = 89). The institutions identified preference for BSC at the time of randomization. A no-treatment arm was allowed (16% received no treatment). Patients were instructed to apply randomized product three times a day, but not within 4 h of their daily RT session. Application began following their first radiation treatment and continued 2 weeks postradiation. Skin dermatitis was scored weekly utilizing the RTOG and ONS (Oncology Nursing Society) skin toxicity scales, a weekly patient satisfaction and quality-of-life questionnaire.

RESULTS:

Using the RTOG toxicity scale there was no overall difference for maximum dermatitis during RT between Biafine and BSC (p = 0.77). There was no difference in maximum toxicity by arm or breast size. There was an interaction between breast size and toxicity, with large-breasted women exhibiting more toxicity. Large-breasted women receiving Biafine were more likely to have no toxicity 6 weeks post RT.

CONCLUSION:

There was no overall difference between BSC and Biafine in the prevention, time to, or duration of radiation-induced dermatitis.

• Authors: J Fisher, C Scott, R Stevens, B Marconi, L Champion, G M Freedman, F Asrari, M V Pilepich, J D Gagnon, G Wong
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 48 Issue 5 Pg. 1307-10 (Dec 01 2000) ISSN: 0360-3016 [Print] United States
• PMID: 11121627 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Multicenter Study, News, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Chemotactic Factors
• Dermatologic Agents
• Gels

Topics

• Adult
• Aged
• Aged, 80 and over
• Aloe (therapeutic use)
• Breast Neoplasms (radiotherapy)
• Chemotactic Factors (therapeutic use)
• Dermatologic Agents (therapeutic use)
• Female
• Gels
• Humans
• Macrophages
• Middle Aged
• Phytotherapy
• Plants, Medicinal
• Radiodermatitis (drug therapy)