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Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):590-595. doi: 10.1016/j.ijrobp.2017.07.019. Epub 2017 Jul 22.

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.

Author information

1
Institut Gustave Roussy, Villejuif, France.
2
Centre Hospitalier de Bretagne Sud, Lorient, France.
3
Centre Hospitalier Intercommunal de Créteil, Créteil, France.
4
Clinique Mutualiste de l'Estuaire, Saint Nazaire, France.
5
Centre René Gauducheau, Saint-Herblain, France.
6
Centre Hospitalier Montbéliard, Montbéliard, France.
7
Centre Hospitalier Départemental Les Oudairies, La Roche-sur-Yon, France.
8
Hôpital Forcilles-Fondation Cognacq Jay, Ferolles-Attilly, France.
9
OTR3 SAS, Paris, France.
10
Institut Gustave Roussy, Villejuif, France; Service de Radio-Oncologie, Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Switzerland. Electronic address: sarah.jorge-lourenco@chuv.ch.

Abstract

PURPOSE:

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.

METHODS AND MATERIALS:

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.

RESULTS:

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).

CONCLUSIONS:

Despite the good preclinical rationale, RGTA did not reduce the incidence and severity of radiodermatitis in patients with HNC.

Comment in

PMID:
29280453
DOI:
10.1016/j.ijrobp.2017.07.019
[Indexed for MEDLINE]

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