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Title: A Randomized Phase II Study of S-1 Adjuvant Chemotherapy With or Without Hochu-ekki-to, a Japanese Herbal Medicine, for Stage II/III Gastric Cancer: The KUGC07 (SHOT) Trial
Authors: Okabe, Hiroshi
Kinjo, Yousuke
Obama, Kazutaka  kyouindb  KAKEN_id
Hosogi, Hisahiro
Hata, Hiroaki
Asao, Yoshito
Harada, Hideki
Manaka, Dai
Itami, Atsushi
Teramukai, Satoshi
Sakai, Yoshiharu  kyouindb  KAKEN_id
Author's alias: 岡部, 寛
金城, 洋介
小濵, 和貴
細木, 久裕
畑, 啓昭
浅生, 義人
原田, 英樹
間中, 大
伊丹, 淳
手良向, 聡
坂井, 義治
Keywords: gastric cancer
adjuvant chemotherapy
herbal medicine
Issue Date: 17-Apr-2019
Publisher: Frontiers Media SA
Journal title: Frontiers in Oncology
Volume: 9
Start page: 294
Abstract: Objectives: A multicenter randomized phase II study was conducted to evaluate the effects of Hochu-ekki-to (TJ-41) for reducing adverse reactions and increasing compliance with S-1 adjuvant therapy for advanced gastric cancer. Methods: The eligibility criteria were pathological stage II/III after R0 resection. Patients received adjuvant therapy with S-1 alone (group S) or S-1 with TJ-41 (group ST) for 1 year. The primary endpoint was the completion rate of S-1. Secondary endpoints were adverse events, relative dose intensity, relapse-free survival (RFS), and overall survival (OS). Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups. Conclusions: TJ-41 does not increase relative dose and completion rate of S-1 significantly. J-41 may reduce toxic effects, but our findings do not support routine use of TJ-41 after gastrectomy.
Rights: © 2019 Okabe, Kinjo, Obama, Hosogi, Hata, Asao, Harada, Manaka, Itami, Teramukai and Sakai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
DOI(Published Version): 10.3389/fonc.2019.00294
PubMed ID: 31058092
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