Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial
Bibliographic record
Abstract
390226 Background: Radiation dermatitis (RD) is common in patients undergoing breast radiation treatment (RT), with worse RD in patients with large breasts and after mastectomy. Mepitel Film (MF), a silicone-based polyurethane film with Safetac technology, may reduce RD. We hypothesized that MF might play a role in preventing RD in this group of patients at risk. Methods: Patients were randomly assigned to receive MF or standard skin care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type (lumpectomy vs. mastectomy), dose fractionation (conventional vs. hypofractionated), and administration of boost/bolus. The primary endpoint was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during RT and within 3 months of completion of RT. Secondary endpoints included CTCAE G3, incidence of moist desquamation, use of topical antibiotic cream, and patient- (PROs) and clinician- (CRO) reported outcomes using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Skin Symptom Assessment (SSA). This study is registered with ClinicalTrials.gov (NCT04166799). Results: Between January 2020 and May 2022, 266 patients (66%) were randomly assigned to MF and 137 (34%) to standard care. After removing withdrawn patients, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared to standard care (n = 39/251, 15.5%; 95% CI, 11.3-20.6% vs. n = 57/125, 45.6%; 95% CI, 36.7-54.8% respectively, odds ratio [OR]: 0.20, P < .0001). Benefits of MF over standard care remained significant in patients who developed G3 RD (n = 7, 2.8%; 95% CI, 1.1-5.7% vs. n = 17, 13.6%; 95% CI, 8.1-20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9-12.0% vs. n = 24, 19.2%; 95% CI, 12.7-27.1%, OR: 0.36). When evaluating the combined patient and health care professional score using the RISRAS, the MF arm had significantly lower scores than standard care ( P < .0001); individual items on the RISRAS also favored MF for PROs (tenderness, discomfort of pain and burning sensation) and CROs (erythema and moist desquamation). Similarly, when assessed by the SSA, blistering/peeling, erythema, pigmentation, and edema in PROs, and pain/soreness, blistering/peeling, erythema, and pigmentation in CROs were significantly reduced in MF. Topical antibiotics were prescribed significantly less frequently in MF (23.1% vs. 43.2%, P < .0001). Three patients removed the film prematurely due to development of an allergic rash (n = 2) and excessive pruritis (n = 1). Conclusions: MF significantly reduces RD in breast cancer patients undergoing RT when compared to the standard care. We recommend changes to the clinical practice for RD prevention and inclusion of MF in high-risk patients in future guideline recommendations. Clinical trial information: NCT04166799.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".