A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan

Jen Shi Chen, Yee Chao, Ruey Kuen Hsieh, Ann Lii Cheng, Po Min Chen, Tzeon Jye Chiou, Tsu Yi Chao, Kun Huei Yeh, Li Tzong Chen, Jacqueline Whang-Peng

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Purpose: To evaluate the efficacy, safety and pharmacokinetic profiles of S-1, which composed of tegafur (FT, a prodrug of 5-FU), 5-chloro-2,4- dihydroxypyridine and potassium oxonate (Oxo), in Taiwanese advanced gastric cancer (AGC) patients. Methods: Patients with chemo-naïve, histologically confirmed AGC were eligible. S-1 was given orally at dose of 40, 50 or 60 mg, twice daily for patients with body surface 1.5 m 2, respectively, on day 1-28 every 42 days/cycle. Results: Thirty-four patients were included. On intent-to-treat analysis, the overall response rate, median progression-free and overall survival were 35.3% [95% confidence interval (CI): 19.2-51.3%], 2.9 (95% CI: 2.4-5.8) months and 9.8 (95% CI: 6.1-NA) months, respectively. The most common grade 3-4 toxicities were anemia 23.5% and neutropenia 11.8%. There were two treatment-related mortality, which occurred in patients with suboptimal renal function underestimated by serum creatinine level at study entry. Single-dose pharmacokinetic study showed trend toward lower AUC5-FU, and higher AUCFT and AUC Oxo comparing to most Western reports. Conclusions: The efficacy, toxicity and pharmacokinetic profiles of S-1 in current study are compatible with those from other Asian populations. Accurate renal function assessment and more closely monitoring is mandatory for S-1 therapy in patients with low body mass. Literature review suggests that, besides AUC5-FU, AUC Oxo may also attribute to the difference in the compliance to S-1 between Asian and Caucasian populations.

Original languageEnglish
Pages (from-to)1281-1289
Number of pages9
JournalCancer Chemotherapy and Pharmacology
Volume67
Issue number6
DOIs
Publication statusPublished - Jun 2011

Keywords

  • Chemotherapy
  • Gastric cancer
  • Pharmacokinetic study
  • Phase II
  • S-1

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

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