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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
oleh: Hiroshi Okabe, Hiroshi Okabe, Yousuke Kinjo, Yousuke Kinjo, Kazutaka Obama, Kazutaka Obama, Hisahiro Hosogi, Hisahiro Hosogi, Hiroaki Hata, Yoshito Asao, Yoshito Asao, Hideki Harada, Dai Manaka, Atsushi Itami, Satoshi Teramukai, Yoshiharu Sakai
| Format: | Article |
|---|---|
| Diterbitkan: | Frontiers Media S.A. 2019-04-01 |
Deskripsi
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.