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

  • Takashi Sasaki
  • Hiroyuki Isayama
  • Yousuke Nakai
  • Suguru Mizuno
  • Keisuke Yamamoto
  • Hiroshi Yagioka
  • Yoko Yashima
  • Kazumichi Kawakubo
  • Hirofumi Kogure
  • Osamu Togawa
  • Saburo Matsubara
  • Yukiko Ito
  • Naoki Sasahira
  • Kenji Hirano
  • Takeshi Tsujino
  • Nobuo Toda
  • Minoru Tada
  • Masao Omata
  • Kazuhiko Koike
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
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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

Authors and Affiliations

  • Takashi Sasaki
    • 1
  • Hiroyuki Isayama
    • 1
  • Yousuke Nakai
    • 1
  • Suguru Mizuno
    • 1
  • Keisuke Yamamoto
    • 1
  • Hiroshi Yagioka
    • 2
  • Yoko Yashima
    • 3
  • Kazumichi Kawakubo
    • 1
  • Hirofumi Kogure
    • 1
  • Osamu Togawa
    • 1
  • Saburo Matsubara
    • 4
  • Yukiko Ito
    • 3
  • Naoki Sasahira
    • 1
  • Kenji Hirano
    • 1
  • Takeshi Tsujino
    • 3
  • Nobuo Toda
    • 5
  • Minoru Tada
    • 1
  • Masao Omata
    • 6
  • Kazuhiko Koike
    • 1
  1. 1.Department of Gastroenterology, Graduate School of MedicineThe University of TokyoTokyoJapan
  2. 2.Department of GastroenterologyJR Tokyo General HospitalTokyoJapan
  3. 3.Department of GastroenterologyJapanese Red Cross Medical CenterTokyoJapan
  4. 4.Department of GastroenterologyKanto Central HospitalTokyoJapan
  5. 5.Department of GastroenterologyMitsui Memorial HospitalTokyoJapan
  6. 6.Yamanashi Prefectural Hospital OrganizationKofuJapan