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ID 55345
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Yokota, T. Division of Gastrointestinal Oncology, Shizuoka Cancer Center
Ogawa, T. Department of Otolaryngology-Head and Neck Surgery, Tohoku University Graduate School of Medicine
Takahashi, S. Department of Medical Oncology, The Cancer Institute Hospital of JFCR
Okami, K. Department of Otolaryngology, Center of Head and Neck Surgery, Tokai University
Fujii, T. Department of Otolaryngology, Head and Neck Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases
Tanaka, K. Department of Medical Oncology, Kindai University Faculty of Medicine
Iwae, S. Department of Head and Neck Cancer, Hyogo Cancer Center
Ota, I. Department of Otolaryngology-Head and Neck Surgery, Nara Medical University
Ueda, T. Department of Otorhinolaryngology-Head and Neck Surgery, Hiroshima University Hospital
Monden, N. Department of Head and Neck Surgery, Shikoku Cancer Center
Matsuura, K. Department of Head and Neck Surgery, Miyagi Cancer Center
Kojima, H. Department of Otorhinolaryngology, Jikei University School of Medicine
Ueda, S. Medical Oncology, Nara Hospital, Kindai University School of Medicine
Sasaki, K. Head and Neck, Chiba Cancer Center
Fujimoto, Y. Department of Otorhinolaryngology, Nagoya University, Graduate School of Medicine
Hasegawa, Y. Department of Head and Neck Surgery, Aichi Cancer Center Hospital and Research Institute
Beppu, T. Division of Head and Neck Surgery, Saitama Cancer Center
Nishimori, Hisakazu Department of Hematology and Oncology, Okayama University Hospital
Hirano, S. Department of Otolaryngology-Head and Neck Surgery, Kyoto University Hospital
Naka, Y. Headquarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd.
Matsushima, Y. Headquarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd.
Fujii, M. Department of Otolaryngology, Eiju General Hospital
Tahara, M. Department of Head and Neck Medical Oncology, National Cancer Center Hospital East
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
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DOI
Web of Sience KeyUT
Related Url
https://doi.org/10.1186/s12885-017-3295-4