Multicenter randomized double-blind, placebo-controlled trial GORTEC 2009-01 evaluating the effect of the regenerating agent RGTA on radiodermatitis of head and neck cancer patients

Publication date: Available online 22 July 2017
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Yungan Tao, Anne Auperin, Christian Sire, Michel Martin, Marie-Gabrielle Saliou, Etienne Bardet, Xu Shan Sun, Thierry Chatellier, Clotilde Morand, Alexandre Cornely, Moussa Angokai, Alessia Di Rito, Ketty Kichenin, Pierre Blanchard, Ida D'Onofrio, Jean Bourhis
BackgroundConcomitant cetuximab and radiotherapy could induce severe radiodermatitis in patients with head and neck cancer (HNC). The OTD70DERM®, a Regenerating Agent (RGTA) is structural and functional analogue of glycosaminoglycans. Pre-clinical studies showed that topical RGTA could markedly reduce radiation-induced mucosal and cutaneous toxicities without tumor protection. This study aimed to transfer this observation in patients to evaluate the effect of topical RGTA on radiodermatitis in a clinical situation for which radio-induced skin reactions are frequent and/or severe i.e. in patients with HNC receiving radiotherapy and cetuximab. The primary endpoint was the incidence of grade ≥2 radiodermatitis.Patients and MethodsA multicenter, randomized, double-blind, placebo-controlled trial was performed on newly diagnosed HNC patients receiving conventionally fractionated RT (70 Gy/ 35 fractions) and weekly cetuximab. Patients were randomized 1:1 to receive topical OTD70DERM® or placebo on irradiated skin once daily. The criteria NCI-CTCAE 3.0 was used for radiodermatitis (photography of radiation zone); and the Dermatology Life Quality Index (DLQI) score was evaluated. All the skin reactions obtained from photographs were scored independently of investigators by two experts.ResultsIn 76 randomized patients (38 in each arm), 72 patients were available for final radiodermatitis evaluation (37 in RGTA arm and 35 in placebo arm). No significant difference was observed concerning the incidence or duration of grade ≥2 radiodermatitis between the two arms (81% for RGTA versus 80% placebo, p = 0.9); no significant difference between two arms regarding grade ≥2 radiodermatitis evaluated by experts regarding the photographs analyzed for 68 patients (76% vs 74%, p = 0.78); and no significant difference of DLQI score was observed (score > 10: 15% vs 20%, p = 0.45).ConclusionDespite a good pre-clinical rationale, RGTA did not reduce the incidence and severity of radiodermatitis in patients with HNC..

Teaser

Pre-clinical studies showed that topical OTD70DERM®, a Regenerating Agent functional analogue of glycosaminoglycans could markedly reduce radiation-induced mucosal and cutaneous toxicities. This hypothesis was tested in a randomized, placebo-controlled trial performed in 76 HNC patients receiving radiotherapy plus cetuximab. No significant difference was observed concerning the incidence or duration of grade ≥2 radiodermatitis between the arms. Despite a good pre-clinical rationale, OTD70DERM® did not reduce the incidence and severity of radiodermatitis.


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