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).

Antineoplastic Combined Chemotherapy Protocols / adverse effects Cisplatin / adverse effects Docetaxel / adverse effects Esophageal Neoplasms / drug therapy Fluorouracil / adverse effects Food, Formulated Humans Prospective Studies
central review system chemotherapy elemental diet esophageal cancer oral mucositis

Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
10 2021
Historique:
received: 25 06 2021
revised: 03 09 2021
accepted: 07 09 2021
pubmed: 10 10 2021
medline: 30 10 2021
entrez: 9 10 2021
Statut: ppublish

Résumé

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. 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. 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). The study findings demonstrate that an ED can prevent OM in patients with esophageal cancer receiving chemotherapy.

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.esmoop.2021.100277 PMID: 34626918 PMC: PMC8511839
pubmed: 34626918
pii: S2059-7029(21)00239-8
doi: 10.1016/j.esmoop.2021.100277
pmc: PMC8511839
pii:
doi:

Substances chimiques

Docetaxel 15H5577CQD
Cisplatin Q20Q21Q62J
Fluorouracil U3P01618RT

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

100277

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure YT, HT, YN, and HN have declared no conflicts of interest. TU reports non-financial support and other support from The Japanese Foundation for Multidisciplinary Treatment of Cancer, during the conduct of the study; and personal fees from Maruho Co., Ltd, Meiji Seika Pharma Co., Ltd, and Otsuka Pharmaceutical Co., Ltd, outside the submitted work. KT has declared no conflicts of interest. SM reports personal fees from Bristol-Myers Squibb Company outside the submitted work. YE, YH, and JH have declared no conflicts of interest. HS reports personal fees from Ono Pharmaceutical Co., Ltd and Bristol-Myers Squibb Company; and grants from Taiho Pharmaceutical Co., Ltd and Chugai Pharmaceutical Co., Ltd, outside the submitted work. EO reports other support from Chugai Pharmaceutical Co., Ltd, Merck Biopharm Co., Ltd, Eli Lilly Japan K.K., Takeda Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, and Bayer, outside the submitted work. CK has declared no conflicts of interest. EO reports grants from SBI Pharmaceuticals Co., Ltd, Takeda Pharmaceutical Co., Ltd, and Johnson & Johnson K.K.; grants and other support from Taiho Pharmaceutical Co., Ltd; and other support from Yakult Honsha Co., Ltd and Chugai Pharmaceutical Co., Ltd, outside the submitted work. HB reports personal fees from Eli Lilly Japan K.K.; grants and personal fees from Taiho Pharmaceutical Co, Ltd and Ono Pharmaceutical Co., Ltd; and grants from Merck Biopharma Co., Ltd and MSD K.K., outside the submitted work. HM and YM have declared no conflicts of interest. YK reports grants and personal fees from EA Pharma Co., Ltd, during the conduct of the study; grants and personal fees from Asahi Kasei Pharma Corporation, Taiho Pharmaceutical Co., Ltd, Chugai Pharmaceutical Co., Ltd, EA Pharma Co., Ltd, Yakult Honsha Co. Ltd, Otsuka Pharmaceutical Co., Ltd, Otsuka Pharmaceutical Factory Inc., Shionogi & Co., Ltd, Kaken Pharmaceutical Co., Ltd, Astellas Pharma Inc., Dainippon Sumitomo Pharma, Ono Pharmaceutical Co., Ltd, Nihon Pharmaceutical Co., Ltd, and Eisai Co., Ltd; and personal fees from Taisho Toyama Pharmaceutical Co., Ltd, Shionogi & Co., Ltd, Sanofi K.K., Kowa Pharmaceutical Co., Ltd, Medicon Inc., Kyowa Hakko Kirin Co., Ltd, Eisai Co., Ltd, Tsumura & Co., Fujifilm Toyama Chemical Co., Ltd, Covidien Japan Inc., Takeda Pharmaceutical Co., Ltd, and Teijin Pharma Ltd, outside the submitted work. KY reports grants and personal fees from Nippon Kayaku, Sanofi K.K., and Yakult Honsha Co. Ltd; grants from Kyowa Kirin; and personal fees from Bristol-Myers Squibb Japan, EA Pharma Co. Ltd, and Pfizer, during the conduct of the study; grants and personal fees from Asahi Kasei Pharma Corporation, Chugai Pharmaceutical Co., Ltd, Covidien Japan Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Johnson & Johnson, Merck Serono, MSD K.K., Novartis, Ono Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co, Ltd, Takeda Pharmaceutical Co., Ltd, and Tsumura & Co.; grants from Abbott, AbbVie, Astellas, Biogen Japan, Celgene, Eisai, GlaxoSmithKline K.K., Kaken Pharmaceutical Co., Ltd, KCI, Meiji Seika Pharma Co. Ltd, Otsuka Pharm, Koninklijke Philips, and Toray Medical; and personal fees from AstraZeneca, Denka Co., Ltd, Olympus, Sanwa Kagaku Kenkyusho, SBI Pharma, Teijin Pharma Ltd, and Terumo, outside the submitted work.

Auteurs

Y Tanaka (Y)

Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.

H Takeuchi (H)

Department of Surgery, School of Medicine, Hamamatsu University, Hamamatsu, Japan.

Y Nakashima (Y)

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

H Nagano (H)

Gastroenterological, Breast and Endocrine Surgery, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.

T Ueno (T)

Department of Dentistry, National Cancer Center Hospital, Tokyo, Japan.

K Tomizuka (K)

Department of Dentistry, Cancer Institute Hospital of JFCR, Tokyo, Japan.

S Morita (S)

Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Y Emi (Y)

Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.

Y Hamai (Y)

Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.

J Hihara (J)

Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.

H Saeki (H)

Department of General Surgical Science, Gunma University, Maebashi, Japan.

E Oki (E)

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

C Kunisaki (C)

Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan.

E Otsuji (E)

Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.

H Baba (H)

Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan.

H Matsubara (H)

Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.

Y Maehara (Y)

Director, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.

Y Kitagawa (Y)

Department of Surgery, Keio University School of Medicine, Tokyo, Japan.

K Yoshida (K)

Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan. Electronic address: kyoshida@gifu-u.ac.jp.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › Protocoles de polychimiothérapie antinéoplasique › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Produits chimiques inorganiques › Composés du platine › Cisplatine › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Composés chimiques organiques › Hydrocarbures › Terpènes › Diterpènes › Taxoïdes › Docetaxel › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies gastro-intestinales › Tumeurs gastro-intestinales › Tumeurs de l'oesophage › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyrimidines › Pyrimidinones › Uracile › Fluorouracil › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Aliments et boissons › Aliments › Aliments spécifiques › Aliment formulé › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Effects of an elemental diet to reduce adverse...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Effects of an elemental diet to reduce adverse...