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Published in: Cancer Chemotherapy and Pharmacology 4/2010

01-03-2010 | Short Communication

Safety, efficacy and pharmacokinetics of S-1 in a hemodialysis patient with advanced gastric cancer

Authors: Nariaki Tomiyama, Muneaki Hidaka, Hideo Hidaka, Yukihiro Kawano, Norihisa Hanada, Hideki Kawaguchi, Kazuhiko Arimori, Chizuko Nakamura

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2010

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Abstract

Purpose

The safety and efficacy of S-1 in hemodialysis patients have not been established. We evaluated the safety and efficacy and pharmacokinetics of S-1 in a hemodialysis patient with advanced gastric cancer.

Patient

A 66-year-old Japanese man with chronic renal failure, who had undergone hemodialysis three times a week for 3 years. Based on the diagnosis of stage IV gastric cancer, S-1 therapy was started. S-1 was administered 11 times at a daily dose of 23.5 mg/m2 (40 mg/body) after hemodialysis, followed by a rest. One course was a period of 28 days. Blood samples were obtained after the first administration of S-1 and before beginning the fourth course. The concentration of 5-FU was determined by high-performance liquid chromatography.

Results

Area under the concentration–time curve (AUC) of 5-FU was 2647.2 ng h/mL after administration of S-1 of 23.5 mg/m2 (40 mg/body). During the S-1 treatment, serious adverse events such as neutropenia were not observed; however, decreases in hemoglobin level were observed (grade 3). The treatment was well tolerated. After the second course of chemotherapy, the primary lesion showed a partial response and lymph node metastases and liver metastases showed stable disease.

Conclusions

Our results suggest that S-1 is an important treatment option for patients with hemodialysis with advanced gastric cancer.
Literature
1.
go back to reference Hirata K, Horikoshi N, Aiba K et al (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000–2005PubMed Hirata K, Horikoshi N, Aiba K et al (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000–2005PubMed
2.
go back to reference Boku N, Yamamoto S, Shirao K et al (2007) Randomized phase III study of 5-fl uorouracil (5-FU) alone versus combination of irinotecan and cisplatin (CP) versus S-1 alone in advanced gastric cancer (JCOG9912). J Clin Oncol 25:18S LBA4513 Boku N, Yamamoto S, Shirao K et al (2007) Randomized phase III study of 5-fl uorouracil (5-FU) alone versus combination of irinotecan and cisplatin (CP) versus S-1 alone in advanced gastric cancer (JCOG9912). J Clin Oncol 25:18S LBA4513
3.
go back to reference Heggie GD, Sommadossi JP, Cross DS et al (1987) Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma, urine, and bile. Cancer Res 47:2203–2206PubMed Heggie GD, Sommadossi JP, Cross DS et al (1987) Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma, urine, and bile. Cancer Res 47:2203–2206PubMed
4.
go back to reference Yamada Y, Hamaguchi T, Goto M et al (2002) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor agent in animal model and in patients with impaired renal function. Cancer Chemother Pharmacol 50:25–32CrossRef Yamada Y, Hamaguchi T, Goto M et al (2002) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor agent in animal model and in patients with impaired renal function. Cancer Chemother Pharmacol 50:25–32CrossRef
5.
go back to reference Tominaga K, Higuchi K, Okazaki H et al (2004) Safety and efficacy of S-1, a novel oral fluorouracil antitumor drug, for a chronic renal failure patient maintained on hemodialysis. Oncology 66:358–364CrossRefPubMed Tominaga K, Higuchi K, Okazaki H et al (2004) Safety and efficacy of S-1, a novel oral fluorouracil antitumor drug, for a chronic renal failure patient maintained on hemodialysis. Oncology 66:358–364CrossRefPubMed
6.
go back to reference Tanaka T, Fujita S, Tanaka N et al (2005) TS-1 treatment for progressive gastric cancer in a patient on chronic dialysis–assessment of dosage regimen by monitoring blood concentrations of therapeutic drugs (TDM) (in Japanese). Gan To Kagaku Ryoho 32:841–845PubMed Tanaka T, Fujita S, Tanaka N et al (2005) TS-1 treatment for progressive gastric cancer in a patient on chronic dialysis–assessment of dosage regimen by monitoring blood concentrations of therapeutic drugs (TDM) (in Japanese). Gan To Kagaku Ryoho 32:841–845PubMed
7.
go back to reference Loos WJ, de Bruijn P, van Zuylen L et al (1999) Determination of 5-fluorouracil in microvolumes of human plasma by solvent extraction and high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 735:293–297CrossRefPubMed Loos WJ, de Bruijn P, van Zuylen L et al (1999) Determination of 5-fluorouracil in microvolumes of human plasma by solvent extraction and high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 735:293–297CrossRefPubMed
8.
go back to reference Yamaoka K, Nakagawa T (1983) A nonlinear least squares program based on differential equations, MULTI (RUNGE), for microcomputers. J Pharmacobiodyn 6:595–606PubMed Yamaoka K, Nakagawa T (1983) A nonlinear least squares program based on differential equations, MULTI (RUNGE), for microcomputers. J Pharmacobiodyn 6:595–606PubMed
9.
go back to reference Taguchi T, Inuyama Y, Kanamaru R et al (1997) Phase I study of S-1. S-1 Study Group (in Japanese). Gan To Kagaku Ryoho 24:2253–2264PubMed Taguchi T, Inuyama Y, Kanamaru R et al (1997) Phase I study of S-1. S-1 Study Group (in Japanese). Gan To Kagaku Ryoho 24:2253–2264PubMed
10.
go back to reference Gamelin EC, Danquechin-Dorval EM, Dumesnil YF et al (1996) Relationship between 5-fluorouracil (5-FU) dose intensity and therapeutic response in patients with advanced colorectal cancer receiving infusional therapy containing 5-FU. Cancer 77:441–451CrossRefPubMed Gamelin EC, Danquechin-Dorval EM, Dumesnil YF et al (1996) Relationship between 5-fluorouracil (5-FU) dose intensity and therapeutic response in patients with advanced colorectal cancer receiving infusional therapy containing 5-FU. Cancer 77:441–451CrossRefPubMed
11.
go back to reference Di Paolo A, Lencioni M, Amatori F et al (2008) 5-fluorouracil pharmacokinetics predicts disease-free survival in patients administered adjuvant chemotherapy for colorectal cancer. Clin Cancer Res 14:2749–2755CrossRefPubMed Di Paolo A, Lencioni M, Amatori F et al (2008) 5-fluorouracil pharmacokinetics predicts disease-free survival in patients administered adjuvant chemotherapy for colorectal cancer. Clin Cancer Res 14:2749–2755CrossRefPubMed
12.
go back to reference van Groeningen CJ, Peters GJ, Schornagel JH et al (2000) Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 18:2772–2779PubMed van Groeningen CJ, Peters GJ, Schornagel JH et al (2000) Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 18:2772–2779PubMed
Metadata
Title
Safety, efficacy and pharmacokinetics of S-1 in a hemodialysis patient with advanced gastric cancer
Authors
Nariaki Tomiyama
Muneaki Hidaka
Hideo Hidaka
Yukihiro Kawano
Norihisa Hanada
Hideki Kawaguchi
Kazuhiko Arimori
Chizuko Nakamura
Publication date
01-03-2010
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-009-1216-1

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