In a Canadian phase III trial reported in the Journal of Clinical Oncology, Behroozian et al found that the use of Mepitel film—a silicone-based polyurethane film dressing—significantly reduced the incidence of grade 2 or 3 acute radiation dermatitis vs usual care in at-risk women receiving radiotherapy after surgery for breast cancer.
As stated by the investigators, “Mepitel film can reduce radiation dermatitis, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of radiation dermatitis.”
In the open-label multicenter trial, 376 women (modified intent-to-treat population) with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or who had undergone mastectomy were randomly assigned 2:1 between January 2020 and May 2022 to receive Mepitel film treatment (n = 251) or usual care (n = 125). Eligible patients were to receive conventional (50 Gy in 25 fractions) or hypofractionated (40–42.6 Gy in 15–16 fractions) radiotherapy to the breast/chest wall plus/minus regional lymph nodes. Mepitel film was applied to the entire breast or chest wall on the first day of radiotherapy; on the last day of radiotherapy, the entire film was replaced to with the aim of providing protection over the 2 weeks following completion of radiotherapy. The primary endpoint was incidence of grade 2 or 3 radiation dermatitis.
Grade 2 or 3 radiation dermatitis occurred in 39 (15.5%, 95% confidence interval [CI] = 11.3%–20.6%) of 251 patients in the Mepitel film group vs 57 (45.6%, 95% CI = 36.7%–54.8%) of 125 in the usual-care group (odds ratio [OR] = 0.20, 95% CI = 0.12–0.34, P < .0001).
Grade 3 dermatitis occurred in 7 patients (2.8%, 95% CI = 1.1%–5.7%) in the Mepitel film group vs 17 patients (13.6%, 95% CI = 8.1%–20.9%) in the usual-care group (OR = 0.19, 95% CI = 0.07–0.45, P < .0002). Moist desquamation occurred in 20 patients (8.0%, 95% CI = 4.9%–12.0%) in the Mepitel film group vs 24 patients (19.2%, 95% CI = 12.7%–27.1%), in the usual-care group (OR = 0.36, 95% CI = 0.19–0.68, P = .002).
On the Radiation-Induced Skin Reaction Assessment Scale, patient assessment showed significantly better scores for the Mepitel film group vs the usual-care group for tenderness and discomfort or pain (P = .001), burning sensation (P = .004), and total score (P = .005); clinician assessment also showed significantly better scores for erythema (P < .0001), moist desquamation (P < .0001), total score (P < .0001), and combined patient and clinician total score (P < .0001).
On the Skin Symptom Assessment Scale, patient assessment showed significantly better scores for the Mepitel film group vs the usual-care group for blistering/peeling (P = .009), erythema (P = .001), pigmentation (P < .0001), and edema (P = .03); clinician assessment showed significantly better scores for pain/soreness (P = .0009), blistering/peeling (P = .009), erythema (P < .0001), and pigmentation (P = .001).
Three patients in the Mepitel film group removed the film prematurely, due to rash in two and excessive pruritus in one.
The investigators concluded, “Mepitel film significantly reduces radiation dermatitis in patients undergoing breast radiotherapy.”
Edward Chow, MBBS, of the Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.