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.
OBJECTIVE
To assess the efficacy of Biafine cream in preventing Grade 2 acute radiation dermatitis, according to the National Cancer Institute of Canada skin radiation toxicity criteria in patients undergoing concomitant adjuvant chemotherapy and radiotherapy to the breast.


METHODS
Sixty patients participated in this study. Patients were treated with a lumpectomy followed by concomitant chemotherapy and radiotherapy to the breast. Biafine cream was applied daily, starting on the first day and ending 2 weeks post-radiotherapy. Patients underwent weekly skin assessments throughout radiotherapy and at 2 and 4 weeks after treatment. Outcome measures were assessed using a Skin Assessment Questionnaire that was scored according to the National Cancer Institute of Canada skin radiation toxicity criteria and a self-administered questionnaire that evaluated skin symptoms.


RESULTS
The maximum skin toxicity observed during the course of treatment was as follows: less than Grade 2 toxicity, 15% (9 patients); Grade 2, 83% (50 patients); Grade 3, 2% (1 patient); Grade 4, 0% (0 patients). The majority of the radiation dermatitis was observed after 3 weeks of radiotherapy.


CONCLUSIONS
The majority of patients who underwent concomitant chemo- and radiotherapy for breast cancer developed Grade 2 radiation dermatitis with the use of Biafine cream. However, no treatment delays or interruptions were observed because of skin toxicity.
Szumacher
E
E
Department of Radiation Oncology, Toronto-Sunnybrook Regional Cancer Centre, Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. ewa.szumacher@tsrcc.on.ca
Wighton
A
A
Franssen
E
E
Chow
E
E
Tsao
M
M
Ackerman
I
I
Andersson
L
L
Kim
J
J
Wojcicka
A
A
Ung
Y
Y
Sixel
K
K
Hayter
C
C
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004655:Emulsions; D005260:Female; D006801:Humans; D008055:Lipids; D015412:Mastectomy, Segmental; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011855:Radiodermatitis / Q000473:pathology / Q000517:prevention & control*; D012837:Silver Sulfadiazine / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires
D000894:Anti-Inflammatory Agents, Non-Steroidal; C423724:Biafine; D003879:Dermatologic Agents; D004655:Emulsions; D008055:Lipids; D012837:Silver Sulfadiazine