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Annals of Oncology Advance Access originally published online on January 15, 2009
Annals of Oncology 2009 20(5):946-949; doi:10.1093/annonc/mdn718
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

phase I and pharmacokinetics

Fixed dosing and pharmacokinetics of S-1 in Japanese cancer patients with large body surface areas

K. Fujita1,2, W. Ichikawa1, W. Yamamoto1, H. Endo1, F. Nagashima1,2, R. Tanaka1, T. Miya1, K. Araki1, K. Kodama1, Y. Sunakawa1, M. Narabayashi1, K. Miwa1, Y. Ando1, Y. Akiyama1,2, K. Kawara1 and Y. Sasaki1,2,*

1 Department of Medical Oncology, Saitama International Medical Center–Comprehensive Cancer Center, Saitama Medical University
2 Project Research Laboratory, Research Center for Genomic Medicine, Saitama Medical University, Hidaka, Japan

* Correspondence to: Dr Y. Sasaki, Department of Medical Oncology, Saitama International Medical Center–Comprehensive Cancer Center, Saitama Medical University, 1397-1 Yamane, Hidaka, Saitama 350-1298, Japan. Tel: +81-42-984-4679; Fax: +81-42-984-4679; E-mail ysasaki{at}saitama-med.ac.jp

Background: S-1 is an oral anticancer agent that combines tegafur (FT) with 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate. The recommended initial dose of S-1 is 120 mg/day for patients with a body surface area (BSA) of ≥1.5 m2 in Japan.

Methods: We examined the effects of using this fixed dose on the pharmacokinetics of FT, CDHP, and active 5-fluorouracil (5-FU) on the basis of actual BSA. The pharmacokinetics was compared between patients with a BSA of 1.5–1.75 m2 and those with a BSA of ≥1.75 m2.

Results: The median areas under the time–concentration curves (AUCs) of 5-FU and CDHP were significantly lower in patients with a BSA of ≥1.75 m2 than in those with a BSA of 1.5–1.75 m2 (P = 0.005 and 0.006, respectively; Mann–Whitney U-test). There was no difference between the groups in the median AUC of FT.

Conclusion: Systemic exposure to 5-FU is significantly lower in Japanese cancer patients with a large BSA of >1.75 m2 who received the recommended fixed dose of S-1.

Key words: 5-FU, Japanese, large body surface area, pharmacokinetics, S-1

Received for publication July 17, 2008. Revision received October 27, 2008. Accepted for publication October 27, 2008.


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