Cancer Chemotherapy and Pharmacology

, Volume 67, Issue 6, pp 1281–1289 | Cite as

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
Original Article

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 <1.25, 1.25–1.5 and >1.5 m2, 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 AUCOxo 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, AUCOxo may also attribute to the difference in the compliance to S-1 between Asian and Caucasian populations.

Keywords

Gastric cancer S-1 Chemotherapy Pharmacokinetic study Phase II 

Supplementary material

280_2010_1416_MOESM1_ESM.doc (34 kb)
Supplementary material 1 (DOC 33 kb)

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Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Jen-Shi Chen
    • 1
  • Yee Chao
    • 2
  • Ruey-Kuen Hsieh
    • 3
  • Ann-Lii Cheng
    • 4
    • 5
  • Po-Min Chen
    • 6
  • Tzeon-Jye Chiou
    • 6
  • Tsu-Yi Chao
    • 7
  • Kun-Huei Yeh
    • 5
    • 8
  • Li-Tzong Chen
    • 9
    • 10
    • 11
  • Jacqueline Whang-Peng
    • 11
    • 12
  1. 1.Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial HospitalChang Gung UniversityTaoyuan CountyTaiwan
  2. 2.Cancer CenterVeterans General HospitalTaipeiTaiwan
  3. 3.Division of Hematology and Oncology, Department of Internal MedicineMacKay Memorial HospitalTaipeiTaiwan
  4. 4.Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
  5. 5.Department of OncologyNational Taiwan University HospitalTaipeiTaiwan
  6. 6.Division of Medical-Oncology, Department of Internal MedicineVeterans General HospitalTaipeiTaiwan
  7. 7.Division of Hematology-Oncology, Department of Internal MedicineTri-Service General HospitalTaipeiTaiwan
  8. 8.Department of Internal MedicineFar Eastern Memorial HospitalTaipeiTaiwan
  9. 9.Department of Internal MedicineNational Cheng Kung University HospitalTainanTaiwan
  10. 10.Department of Internal Medicine, Kaohsiung Medical University HospitalKaohsiung Medical UniversityKaohsiungTaiwan
  11. 11.National Institute of Cancer Research, National Health Research InstitutesTainanTaiwan
  12. 12.Cancer Center Wan Fang HospitalTaipei Medical UniversityTaipeiTaiwan, ROC

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