Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial
Notice bibliographique
Résumé
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 After removing withdrawn patients, 376 patients were included in the modified intention-to-treat analysis.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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».