Clinical Trial Note

S-1 Monotherapy in Patients with Advanced Biliary Tract Cancer
Takashi Sasaki^a, Hiroyuki Isayama^a, Yoko Yashima^a, Hiroshi Yagioka^a, Hirofumi Kogure^a, Toshihiko Arizumi^a, Osamu Togawa^a, Saburo Matsubara^a, Yukiko Ito^c, Yousuke Nakai^a, Naoki Sasahira^a, Kenji Hirano^a, Takeshi Tsujino^a, Minoru Tada^a, Takao Kawabe^b, Masao Omata^a

Departments of
^aGastroenterology, and
^bEndoscopy and Endoscopic Surgery, Faculty of Medicine, University of Tokyo,
^cDepartment of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan

Address of Corresponding Author

Oncology 2009;77:71-74 (DOI: 10.1159/000226214)

  Key Words

• S-1
• Biliary tract cancer
• Chemotherapy

  Abstract

Objective: The aim of this study was to evaluate the efficacy and safety of single-agent S-1 in patients with advanced biliary tract cancer. Methods: S-1 was administered orally at a dose of 80 mg/m² for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal. Results: Forty-five patients were enrolled between January 2005 and June 2008. Among these, 29 patients received S-1 as first-line chemotherapy and 16 patients received S-1 as second-line chemotherapy. The response rates for first- and second-line chemotherapy were 17.2 and 18.8%, respectively. The median times to progression for the first- and second-line chemotherapy groups were 4.2 and 5.5 months (p = 0.91), respectively. The median overall survival and 1-year survival rate for each group were 8.7 and 8.0 months and 42.2 and 38.2%, respectively (p = 0.62). Only the first-line chemotherapy group experienced grade 3/4 toxicities, including leukopenia (6.9%), neutropenia (10.3%), anemia (6.9%), thrombocytopenia (10.3%) and total bilirubin elevation (3.4%). Conclusion: S-1 monotherapy is a feasible and moderately efficacious treatment for advanced biliary tract cancer, as a first- or second-line chemotherapy regimen.

Copyright © 2009 S. Karger AG, Basel

  Author Contacts

Takashi Sasaki, MD
Department of Gastroenterology, Faculty of Medicine
University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 (Japan)
Tel. +81 3 3815 5411, ext. 33056, Fax +81 3 3814 0021, E-Mail sasakit-tky@umin.ac.jp

  Article Information

Received: December 22, 2008
Accepted after revision: February 25, 2009
Published online: June 26, 2009
Number of Print Pages : 4
Number of Figures : 1, Number of Tables : 2, Number of References : 7