Mepitel Film reduces dermatitis in breast cancer patients undergoing radiation therapy: ASCO

When compared to conventional therapy, Mepitel Film (MF) dramatically lowers radiation dermatitis (RD) in breast cancer patients undergoing radiation treatment (RT), says an article published in American Society of Clinical Oncology.

Those receiving breast radiotherapy frequently develop radiation dermatitis, which is exacerbated in patients with big breasts and following mastectomy. Mepitel Film, a polyurethane film made of silicone and with Safetac technology, could lessen RD. As a result, Edward Chow and his team proposed that MF may contribute to RD prevention in this at-risk patient population.

Patients were randomized at random to undergo MF or conventional skin care (2:1 ratio). Patients with big breasts after mastectomy or after lumpectomy (bra size ≥ 36 inches or cup size ≥C) were eligible. Surgery type (lumpectomy vs. mastectomy), dosage fractionation (conventional vs. hypofractionated), and boost/bolus delivery were also stratification variables. The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade (G) 2 or 3 RD utilizing the RT and within 3 months of RT completion was the main objective. CTCAE G3, the frequency of moist desquamation, the use of topical antibiotic cream, and patient- and clinician-reported outcomes using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Skin Symptom Assessment (SSA) were among the secondary objectives.

The key findings of this study were:

1. 266 patients received MF between January 2020 and May 2022, while 137 received conventional treatment. 376 patients were included in the modified intention-to-treat analysis after the withdrawn patients were excluded.

2. When MF patients were compared to those receiving conventional treatment, the incidence of G2 or 3 RD was noticeably reduced.

3. In patients who developed G3 RD and moist desquamation, the benefits of MF over conventional treatment remained substantial.

4. The MF arm received considerably lower scores than standard care when the patient and healthcare professional scores were pooled using the RISRAS; individual RISRAS items similarly preferred MF for PROs and CROs.

5. Additionally, according to the SSA, MF had much less blistering/peeling, erythema, pigmentation, and edema in PROs and CROs, as well as discomfort and soreness.

6. Significantly fewer topical antibiotic prescriptions were made in MF. Three patients prematurely removed the film because they had severe pruritis and an allergic reaction.

In conclusion, future guideline recommendations should include MF in high-risk individuals and modifications to clinical practice for RD prevention.

Reference:

Chow E, et al., Mepitel film for the prevention of acute radiation dermatitis in breast cancer: a randomized multi-centre open-label phase 3 trial. ASCO Virtual Plenary 2022.