Effects of an elemental diet to reduce adverse events in patients with esophageal cancer receiving docetaxel/cisplatin/5-fluorouracil: a phase III randomized controlled trial—EPOC 2 (JFMC49-1601-C5) ☆

ESMO Open

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Y. Tanaka¹  H. Takeuchi²  Y. Nakashima³  H. Nagano⁴  T. Ueno⁵  K. Tomizuka⁶  S. Morita⁷  Y. Emi⁸  Y. Hamai⁹  J. Hihara^1,10  H. Saeki^1,11  E. Oki³  C. Kunisaki^1,12  E. Otsuji^1,13  H. Baba^1,14  H. Matsubara^1,15  Y. Maehara^1,16  Y. Kitagawa^1,17  K. Yoshida¹ 

[1] Department of Surgical Oncology, Graduate School of Medicine, Gifu University;Department of Surgery, School of Medicine, Hamamatsu University;Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University;Gastroenterological, Breast and Endocrine Surgery, Graduate School of Medicine, Yamaguchi University;Department of Dentistry, National Cancer Center Hospital;Department of Dentistry, Cancer Institute Hospital of JFCR;Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University;Department of Surgery, Saiseikai Fukuoka General Hospital;Department of Surgical Oncology, Hiroshima University Hospital;Department of Surgery, Hiroshima City Asa Citizens Hospital;Department of General Surgical Science, Gunma University;Department of Surgery, Gastroenterological Center, Yokohama City University;Department of Surgery, Kyoto Prefectural University of Medicine;Department of Gastroenterological Surgery, Kumamoto University;Department of Frontier Surgery, Graduate School of Medicine, Chiba University;Director, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers;Department of Surgery, Keio University School of Medicine

关键词: oral mucositis;    elemental diet;    chemotherapy;    central review system;    esophageal cancer;   

DOI  :  10.1016/j.esmoop.2021.100277

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background Oral mucositis (OM) is an unpleasant adverse event in patients receiving chemotherapy. A prospective feasibility study showed that elemental diet (ED), an oral supplement that does not require digestion, may prevent OM. Based on this, we established a central review system for oral cavity assessment by dental oncology specialists blinded to background data. We used this system to elucidate the preventive effect of an ED against OM in patients with esophageal cancer receiving docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy.Patients and methods In this phase III, multicenter, parallel-group, controlled trial, patients consuming a normal diet orally were randomly assigned (1 : 1) to receive two cycles of DCF with (group A) or without (group B) an ED (Elental® 160 g/day). We assessed the incidence of grade ≥2 OM evaluated by two reviewers, changes in body weight, prealbumin, C-reactive protein, and DCF completion rate based on ED compliance.Results Of the 117 patients randomly assigned to treatment, four failed to start treatment and were excluded from the primary analysis; thus, groups A and B comprised 55 and 58 patients, respectively. There were no significant differences in background characteristics. Grade ≥2 OM was observed in eight (15%) and 20 (34%) patients in groups A and B, respectively (P = 0.0141). Changes in body weight and prealbumin during the two DCF cycles were significantly higher in group A than B (P = 0.0022 and 0.0203, respectively). During the first cycle, changes in C-reactive protein were significantly lower in group A than B (P = 0.0338). In group A (receiving ED), the DCF completion rate was 100% in patients with 100% ED compliance and 70% in patients failing ED completion (P = 0.0046).Conclusions The study findings demonstrate that an ED can prevent OM in patients with esophageal cancer receiving chemotherapy.

【 授权许可】

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