Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoingbreast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13
J. Fisher et al., Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoingbreast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13, INT J RAD O, 48(5), 2000, pp. 1307-1310
Citations number
5
Categorie Soggetti
Radiology ,Nuclear Medicine & Imaging","Onconogenesis & Cancer Research
Journal title
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
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 t
heir first radiation treatment and continued 2 weeks postradiation. Skin de
rmatitis was scored weekly utilizing the RTOG and ONS (Oncology Nursing Soc
iety) skin toxicity scales, a weekly patient satisfaction and quality-of-li
fe 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,vas
no difference in maximum toxicity by arm or breast size. There was an inter
action between breast size and toxicity, with large-breasted women exhibiti
ng more toxicity. Large-breasted women receiving Biafine were more likely t
o 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. (C) 2000
Elsevier Science Inc.