FullText URL s12885-017-3295-4.pdf
Author Yokota, T.| Ogawa, T.| Takahashi, S.| Okami, K.| Fujii, T.| Tanaka, K.| Iwae, S.| Ota, I.| Ueda, T.| Monden, N.| Matsuura, K.| Kojima, H.| Ueda, S.| Sasaki, K.| Fujimoto, Y.| Hasegawa, Y.| Beppu, T.| Nishimori, Hisakazu| Hirano, S.| Naka, Y.| Matsushima, Y.| Fujii, M.| Tahara, M.|
Abstract BACKGROUND: Recent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC). METHODS: Patients aged 20-75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee. RESULTS: From April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups. CONCLUSIONS: The present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide. TRIAL REGISTRATION: ClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March 11, 2014).
Keywords Chemoradiotherapy Head and neck cancer Oral mucositis Placebo-controlled Randomized Rebamipide liquid
Published Date 2017-05-05
Publication Title BMC cancer
Volume volume17
Issue issue1
Publisher BioMed Central
Start Page 314
End Page 322
ISSN 1471-2407
NCID AA12034763
Content Type Journal Article
language 英語
OAI-PMH Set 岡山大学
Copyright Holders https://creativecommons.org/licenses/by-nc-nd/4.0/deed.ja
File Version publisher
PubMed ID 28476132
DOI 10.1186/s12885-017-3295-4
Web of Sience KeyUT 000401614700001
Related Url https://doi.org/10.1186/s12885-017-3295-4