Multicenter Randomized Double-Blind, Placebo-Controlled Trial GORTEC (Groupe Oncologie Radiotherapie Tete et Cou) 2009-01 Evaluating the Effect of the Regenerating Agent on Radiodermatitis of Head and Neck Cancer Patients.

Détails

ID Serval
serval:BIB_4C686C881374
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Multicenter Randomized Double-Blind, Placebo-Controlled Trial GORTEC (Groupe Oncologie Radiotherapie Tete et Cou) 2009-01 Evaluating the Effect of the Regenerating Agent on Radiodermatitis of Head and Neck Cancer Patients.
Périodique
International journal of radiation oncology, biology, physics
Auteur(s)
Tao Y., Auperin A., Sire C., Martin M., Saliou M.G., Bardet E., Sun X.S., Chatellier T., Morand C., Cornely A., Angokai M., Di Rito A., Kichenin K., Blanchard P., D'Onofrio I., Bourhis J.
ISSN
1879-355X (Electronic)
ISSN-L
0360-3016
Statut éditorial
Publié
Date de publication
01/11/2017
Peer-reviewed
Oui
Volume
99
Numéro
3
Pages
590-595
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
Concomitant cetuximab and radiation therapy (RT) can induce severe radiodermatitis in patients with head and neck cancer (HNC). OTD70DERM, a regenerating agent (RGTA), is a structural and functional analogue of glycosaminoglycans. Preclinical studies have shown that topical RGTA can markedly reduce radiation-induced mucosal and cutaneous toxicities without tumor protection. The present study aimed to evaluate the effect of topical RGTA on radiodermatitis in patients with HNC undergoing RT and cetuximab, for whom RT-induced skin reactions are frequent and/or severe. The primary endpoint was the incidence of grade ≥2 radiodermatitis.
We performed a multicenter, randomized, double-blind, placebo-controlled trial of patients with newly diagnosed HNC undergoing conventionally fractionated RT (70 Gy in 35 fractions) and weekly cetuximab. Patients were randomized 1:1 to receive topical OTD70DERM or placebo on irradiated skin once daily. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, was used to evaluate radiodermatitis (photographs of radiation zone). The Dermatology Life Quality Index score was also evaluated. All the skin reactions seen on the photographs were scored independently by 2 outside experts.
Of the 76 randomized patients (38 in each arm), 72 were available for the final radiodermatitis evaluation (37 in the RGTA arm and 35 in the placebo arm). No significant difference was observed concerning the incidence or duration of grade ≥2 radiodermatitis between the 2 arms (81% for RGTA vs 80% for placebo; P=.9). Also, no significant difference was found between the 2 arms regarding grade ≥2 radiodermatitis evaluated by the 2 experts using the photographs of 68 patients (76% vs 74%; P=.78). Finally, no significant difference was found in the Dermatology Life Quality Index score (score >10, 15% vs 20%; P=.45).
Despite the good preclinical rationale, RGTA did not reduce the incidence and severity of radiodermatitis in patients with HNC.
Mots-clé
Administration, Topical, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological/administration & dosage, Cetuximab/administration & dosage, Dermatologic Agents/administration & dosage, Dose Fractionation, Radiation, Female, Glycosaminoglycans/administration & dosage, Head and Neck Neoplasms/radiotherapy, Humans, Male, Middle Aged, Protective Agents/administration & dosage, Radiation-Protective Agents/administration & dosage, Radiodermatitis/drug therapy, Radiodermatitis/prevention & control
Pubmed
Web of science
Création de la notice
13/01/2018 10:24
Dernière modification de la notice
20/08/2019 14:00
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