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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2010

01-05-2010 | Original Article

Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Authors: Takashi Sasaki, Hiroyuki Isayama, Yousuke Nakai, Yukiko Ito, Hirofumi Kogure, Osamu Togawa, Nobuo Toda, Ichiro Yasuda, Osamu Hasebe, Iruru Maetani, Naoki Sasahira, Kenji Hirano, Takeshi Tsujino, Minoru Tada, Masao Omata

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2010

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Abstract

Purpose

To evaluate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer.

Methods

Patients with a measurable lesion and no previous history of chemotherapy or radiotherapy were enrolled. Gemcitabine was administered intravenously at a dose of 1,000 mg/m2 over 30 min on day 1 and 15, repeated every 4 weeks. S-1 was administered orally at a dose of 40 mg/m2 b.i.d. on days 1–14. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria.

Results

As much as 35 patients were enrolled between December 2006 and July 2008; 14 patients (40%) with gallbladder cancer and 14 (40%) with intrahepatic cholangiocarcinoma were included and 7 patients (20%) had received previous surgical resection. The overall response rate was 34.3% and the overall disease control rate was 82.9%. The median overall survival time was 11.6 months (95% CI, 7.3–15.6 months), and the median time to progression was 5.9 months (95% CI, 4.0–7.7 months). The grade 3/4 toxicities were leucopenia (23%), neutropenia (34%), anemia (20%), thrombocytopenia (6%) and anorexia (3%).

Conclusions

Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.
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Metadata
Title
Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Authors
Takashi Sasaki
Hiroyuki Isayama
Yousuke Nakai
Yukiko Ito
Hirofumi Kogure
Osamu Togawa
Nobuo Toda
Ichiro Yasuda
Osamu Hasebe
Iruru Maetani
Naoki Sasahira
Kenji Hirano
Takeshi Tsujino
Minoru Tada
Masao Omata
Publication date
01-05-2010
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-009-1115-5

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