Kouvaris, J.R., Kouloulias, V.E., Plataniotis, G.A., Balafouta, E.J., & Vlahos, L.J. (2001). Dermatitis during radiation for vulvar carcinoma: Prevention and treatment with granulocyte-macrophage colony-stimulating factor impregnated gauze. Wound Repair and Regeneration, 9, 187–193.

To determine effectiveness of GM-CSF impregnated gauze in preventing and healing acute radiation-induced dermatitis

The study took place from November 1981 to March 1998. Group A (n = 37) was comprised of patients treated from 1981 to 1993 and received steroid creams (e.g., Betamethasone) as prophylaxis to radiation-induced dermatitis. Group B (n = 24) was comprised of patients treated from 1993 to 1998 and received steroid creams from the start of treatment and, following 20 Gy of radiation, also recieved GM-CSF impregnated gauze. Dressings were applied twice daily, 12 hours apart, for the rest of their treatment, while steroid cream was applied once a day, intermediately. The same doctors and technicians treated all patients during this time interval and were evaluated using a standard protocol. Findings from both groups were analyzed retrospectively.

• The study sample was comprised of 61 female patients.
• Median age of the sample was 74 years, with a range of 38–84 years.
• Patients had a diagnosis of invasive squamous cell carcinoma of the vulva.

The study took place at a university hospital in Greece.

The study used a retrospective design.

• Patients were examined clinically twice a week to estimate the cutaneous reactions to the groin areas, vulva, perineum, and labiocrural folds.
• Radiation dermatitis was classified in four grades using Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scoring.
• Pain was classified into four grades according to the subjective scale of Subjective Objective Management Analytic grading system.

Group B had overall lower subjective pain results (p = 0.0014). Those who had received the GM-CSF had overall less severe skin toxicity by RTOG/EORTC grading (p = 0.008).

GM-CSF impregnated gauze can be effective in preventing and healing radiation-induced dermatitis and in reducing the interruption intervals in radiation therapy for vulvar carcinomas.

• The sample size is small, with less than 50 patients.
• The study used a nonrandomized, retrospective design. Small non-randomized study, retrospective study, Low accumulation of participants:12 years of study for group A (37 patients)
• Group A had 12 years of study and Group B had 5 years of study.
• The study did not specify the breakdown of stage and grade of cancers in each group, and a wide range of patient characteristics in body mass were included.
• The study did not specify number of patients per group who had surgery before radiation, required a boost dose, required pelvic radiation, or had a treatment break.
• No explanation/validation of the SOMA pain grading system was provided.