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.
OBJECTIVE
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
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.


CONCLUSIONS
There was no overall difference between BSC and Biafine in the prevention, time to, or duration of radiation-induced dermatitis.
Fisher
J
J
Radiation Oncology Center, Oakwood Hospital and Medical Center, Dearborn, MI 48123, USA. fisherj@oakwood.org
Scott
C
C
Stevens
R
R
Marconi
B
B
Champion
L
L
Freedman
G M
GM
Asrari
F
F
Pilepich
M V
MV
Gagnon
J D
JD
Wong
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000504:Aloe / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000532:radiotherapy*; D002630:Chemotactic Factors / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D008264:Macrophages; D008875:Middle Aged; D008517:Phytotherapy; D010946:Plants, Medicinal; D011855:Radiodermatitis / Q000188:drug therapy*
D002630:Chemotactic Factors; D003879:Dermatologic Agents; D005782:Gels