Investigational New Drugs

, Volume 30, Issue 2, pp 708–713

Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine

Authors

  • Takashi Sasaki
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Yousuke Nakai
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Suguru Mizuno
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Keisuke Yamamoto
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Hiroshi Yagioka
    • Department of GastroenterologyJR Tokyo General Hospital
  • Yoko Yashima
    • Department of GastroenterologyJapanese Red Cross Medical Center
  • Kazumichi Kawakubo
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Hirofumi Kogure
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Osamu Togawa
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Saburo Matsubara
    • Department of GastroenterologyKanto Central Hospital
  • Yukiko Ito
    • Department of GastroenterologyJapanese Red Cross Medical Center
  • Naoki Sasahira
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Kenji Hirano
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Takeshi Tsujino
    • Department of GastroenterologyJapanese Red Cross Medical Center
  • Nobuo Toda
    • Department of GastroenterologyMitsui Memorial Hospital
  • Minoru Tada
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Masao Omata
    • Yamanashi Prefectural Hospital Organization
  • Kazuhiko Koike
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
PHASE II STUDIES

DOI: 10.1007/s10637-010-9553-9

Cite this article as:
Sasaki, T., Isayama, H., Nakai, Y. et al. Invest New Drugs (2012) 30: 708. doi:10.1007/s10637-010-9553-9

Summary

Gemcitabine is widely used for the treatment of advanced biliary tract cancer (BTC) as first-line chemotherapy. However, there is no standard chemotherapy for patient with advanced BTC refractory to gemcitabine. We conducted a multicenter phase II study of S-1 monotherapy as second-line chemotherapy for patients with advanced BTC that were refractory to gemcitabine. S-1 was administered orally at a dose of 80 mg/m2 for 28 days, followed by 14 days of rest. This regimen was repeated every 6 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty-two patients were enrolled between March 2007 and January 2010, with 14 patients (64%) representing cases of recurrence after surgery. The overall response rate was 22.7%, and the overall disease control rate was 50.0%. The median overall survival time was 13.5 months (95% CI, 7.1–23.1 months) and the median time-to-progression was 5.4 months (95% CI, 2.6–17.2 months). Grade 3/4 toxicities included neutropenia (5%) and anemia (5%). The most common non-hematological toxicities were nausea (27%), anorexia (55%), and pigmentation (32%). In conclusion, S-1 monotherapy is feasible and moderately efficacious second-line chemotherapy for advanced BTC.

Keywords

Biliary tract cancerS-1GemcitabineSecond-line

Copyright information

© Springer Science+Business Media, LLC 2010