Randomised Phase II Study of S-1/cisplatin Plus TSU-68 Vs S-1/cisplatin in Patients with Advanced Gastric Cancer

Overview

Journal Br J Cancer

Specialty Oncology

Date 2013 Sep 19

PMID 24045669

Citations 16

Authors

W Koizumi

K Yamaguchi

H Hosaka

Y Takinishi

N Nakayama

T Hara

K Muro

H Baba

Y Sasaki

T Nishina

N Fuse

T Esaki

M Takagi

M Gotoh

T Sasaki

Affiliations

Soon will be listed here.

Abstract

Background: This study aimed to determine whether combination S-1 plus cisplatin (CDDP) therapy, the most widely used therapy for Japanese patients with advanced gastric cancer, and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment.

Methods: Ninety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were randomised into two groups: TSU-68 plus S-1/CDDP (group A) and S-1/CDDP (group B) groups. Both patient groups received identical S-1 and CDDP dosages. TSU-68 was orally administered for 35 consecutive days. Group B patients received S-1 orally twice daily for three consecutive weeks, followed by intravenous CDDP on day 8. The primary endpoint was progression-free survival (PFS).

Results: Median PFS periods were 208 and 213 days in groups A and B, respectively (P=0.427). Median survival periods for groups A and B were 497.0 and 463.5 days, respectively (P=0.219). No statistically significant differences were noted for PFS, survival or the adverse event (AE) incidence rate. All AEs were expected according to previous reports for TSU-68, TS-1, and CDDP.

Conclusion: Combination therapy involving TSU-68, S-1, and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers. However, factors related to therapeutic efficacy should be investigated further.

Citing Articles

Recent Trends and Advancements in the Diagnosis and Management of Gastric Cancer.

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Molecularly Targeted Therapies for Gastric Cancer. State of the Art.

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Current Molecular Targeted Agents for Advanced Gastric Cancer.

Nie S, Yang G, Lu H Onco Targets Ther. 2020; 13:4075-4088.

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The clinical outcomes of S-1 plus cisplatin for patients with advanced gastric cancer: A meta-analysis and systematic review.

Yang L, Wang X, Wang B, Chao P, Li D, Chai C Medicine (Baltimore). 2018; 97(49):e12789.

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