Phase 3 randomized trial of topical steroid versus placebo for prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiation.

Abstract

PURPOSE\nRadiation dermatitis is one of the most common acute toxicities induced by chemoradiotherapy (CRT) for head and neck cancer (HNC). The benefit of topical steroids in the management of radiation dermatitis is still unclear. This phase 3, multi-institutional, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical steroids for radiation dermatitis in\xa0patients with locally advanced HNC receiving CRT.\n\n\nMETHODS AND MATERIALS\nEligible patients were scheduled to receive bilateral neck irradiation (≥ 66 Gy) with concurrent cisplatin (≥ 200 mg/m2) as definitive or postoperative CRT. Patients were randomly assigned to receive either topical steroid or placebo when radiation dermatitis grade 1 was observed or the total radiation dose reached 30 Gy. Basic skin care including gentle washing and moistening in the head and neck region was performed in both groups. The primary endpoint was frequency of ≥ grade 2 radiation dermatitis, in accordance with NCI Common Terminology Criteria for Adverse Events version 4.0. Grading of radiation dermatitis was performed by independent central review using photographs taken weekly.\n\n\nRESULTS\nA total of 211 patients were enrolled (intention to treat: steroid 101 and placebo 102). The frequency of ≥ grade 2 radiation dermatitis was not significantly reduced with the steroid [73.3% (95% CI: 64.6-81.9)] compared with that with the placebo [80.4% (95% CI: 72.7-88.1), p\u202f=\u202f0.23], while steroid significantly reduced the frequency of ≥ grade 3 radiation dermatitis (13.9% vs. 25.5%, p\u202f=\u202f0.034). No significant differences in adverse events including local infection or in CRT compliance were seen between the groups.\n\n\nCONCLUSIONS\nTopical steroid may reduce the severity of radiation dermatitis in HNC patients and thereby potentially become an important therapeutic tool in the management of radiation dermatitis.