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

研究成果: 雜誌貢獻文章

6 引文 (Scopus)

摘要

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.
原文英語
頁(從 - 到)1281-1289
頁數9
期刊Cancer Chemotherapy and Pharmacology
67
發行號6
DOIs
出版狀態已發佈 - 六月 2011

指紋

Pharmacokinetics
Taiwan
Stomach Neoplasms
Toxicity
Tegafur
Prodrugs
Confidence Intervals
Fluorouracil
Area Under Curve
Creatinine
Kidney
Monitoring
Neutropenia
Population
Disease-Free Survival
Anemia
Safety
Mortality
Therapeutics
Serum

ASJC Scopus subject areas

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

引用此文

A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan. / Chen, Jen Shi; Chao, Yee; Hsieh, Ruey Kuen; Cheng, Ann Lii; Chen, Po Min; Chiou, Tzeon Jye; Chao, Tsu Yi; Yeh, Kun Huei; Chen, Li Tzong; Whang-Peng, Jacqueline.

於: Cancer Chemotherapy and Pharmacology, 卷 67, 編號 6, 06.2011, p. 1281-1289.

研究成果: 雜誌貢獻文章

Chen, Jen Shi ; Chao, Yee ; Hsieh, Ruey Kuen ; Cheng, Ann Lii ; Chen, Po Min ; Chiou, Tzeon Jye ; Chao, Tsu Yi ; Yeh, Kun Huei ; Chen, Li Tzong ; Whang-Peng, Jacqueline. / A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan. 於: Cancer Chemotherapy and Pharmacology. 2011 ; 卷 67, 編號 6. 頁 1281-1289.
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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-na{\"i}ve, 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.",
keywords = "Chemotherapy, Gastric cancer, Pharmacokinetic study, Phase II, S-1",
author = "Chen, {Jen Shi} and Yee Chao and Hsieh, {Ruey Kuen} and Cheng, {Ann Lii} and Chen, {Po Min} and Chiou, {Tzeon Jye} and Chao, {Tsu Yi} and Yeh, {Kun Huei} and Chen, {Li Tzong} and Jacqueline Whang-Peng",
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T1 - A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan

AU - Chen, Jen Shi

AU - Chao, Yee

AU - Hsieh, Ruey Kuen

AU - Cheng, Ann Lii

AU - Chen, Po Min

AU - Chiou, Tzeon Jye

AU - Chao, Tsu Yi

AU - Yeh, Kun Huei

AU - Chen, Li Tzong

AU - Whang-Peng, Jacqueline

PY - 2011/6

Y1 - 2011/6

N2 - 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.

AB - 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.

KW - Chemotherapy

KW - Gastric cancer

KW - Pharmacokinetic study

KW - Phase II

KW - S-1

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