Mepitel Film can reduce the risk of radiation dermatitis in patients with breast cancer, according to research presented as part of the 2022 ASCO Monthly Plenary Series for October.
Mepitel Film, an adhesive silicone skin dressing, proved more effective than standard care for preventing grade 2-3 radiation dermatitis in patients with breast cancer who had undergone mastectomy or lumpectomy before undergoing radiotherapy (RT).
Based on these results, researchers recommend the use of Mepitel Film for preventing moderate to severe radiation dermatitis in patients at high risk.
The researchers conducted this phase 3 trial (ClinicalTrials.gov Identifier: NCT04166799) in 376 patients with breast cancer who had undergone lumpectomy or mastectomy. Patients who underwent a lumpectomy had a bra size of at least 36 inches and/or a cup size of C or higher.
The patients were scheduled to receive conventional or hypo-fractionated RT to the whole breast or chest wall, with or without regional lymph nodes.
The patients were randomly assigned 2:1 to receive Mepitel Film (n=251) or standard skin care (n=125) during RT. Baseline characteristics were well balanced between the treatment arms. There was 1 male patient.
Mepitel Film was applied on the first day of RT and was replaced on the last day of RT, to be worn for an additional 2 weeks after RT completion. Patients in the standard care arm received aqueous cream, saline compresses, topical corticosteroids and antibiotics, oral analgesics, and home care/dressings.
There were 8 patients who switched from Mepitel Film to standard care — 2 due to an allergic rash, 1 due to excessive pruritus, and 5 for other reasons. One patient withdrew from the standard care arm due to an unwillingness to complete follow-up.
The primary endpoint was grade 2-3 radiation dermatitis during RT and within 3 months of completing RT. The incidence of grade 2-3 radiation dermatitis was significantly lower in the Mepitel Film arm than in the standard care arm — 15.54% and 45.60%, respectively (odds ratio [OR], 0.20; 95% CI, 0.12-0.34; P <.0001).
The incidence of grade 3 radiation dermatitis alone was also significantly lower with Mepitel Film than with standard care — 2.79% and 13.60%, respectively (OR, 0.19; 95% CI, 0.07-0.45; P <.0002).
The incidence of moist desquamation was lower in the Mepitel Film arm than in the standard care arm as well — 7.97% and 19.20%, respectively (OR, 0.36; 95% CI, 0.19-0.68; P =.002).
Topical antibiotics were required in 23.1% of patients in the Mepitel Film arm and 43.2% of those in the standard care arm (P <.0001). There was no significant difference in the use of topical steroids between the arms.
Compared with patients who received standard care, patients treated with Mepitel Film reported significantly less tenderness, discomfort, or pain (P =.001); burning sensation (P =.004); blistering or peeling (P =.009); erythema (P =.001); pigmentation changes (P <.0001); and edema (P =.03). Clinicians reported similar improvements.
Disclosures: Mepitel Film for this study was supplied by Molnlycke Health Care LTD. Please see the original reference for a full list of disclosures.
Chow E, Behroozian T, Milton L, et al. Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial. ASCO Monthly Plenary Series 2022. October 18, 2022. Abstract 390226.