Investigational New Drugs

, Volume 29, Issue 6, pp 1488–1493

Feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with refractory biliary tract cancer

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

DOI: 10.1007/s10637-010-9485-4

Cite this article as:
Sasaki, T., Isayama, H., Nakai, Y. et al. Invest New Drugs (2011) 29: 1488. doi:10.1007/s10637-010-9485-4

Summary

Gemcitabine and cisplatin combination chemotherapy have been shown to have promising efficacy for the treatment of advanced biliary tract cancer (BTC) as a first-line chemotherapy. However, this treatment has not been approved for clinical practice in Japan. Oral fluoropyrimidines (e.g., S-1 and capecitabine) are also promising agents that are widely used with or without gemcitabine. Unfortunately, there is no standard chemotherapy for patients refractory to gemcitabine and oral fluoropyrimidine. We conducted a feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with advanced BTC who are refractory to gemcitabine and S-1. Gemcitabine (1,000 mg/m2) and cisplatin (25 mg/m2) were administered intravenously on days 1 and 8, and this regimen was repeated every 3 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty patients with pathologically confirmed BTC were enrolled. Gemcitabine and cisplatin combination chemotherapy was administered as a second-line chemotherapy in thirteen patients and as a third-line chemotherapy in seven patients. Tumor response did not occur in any of the cases. Fourteen patients demonstrated stable diseases, and the disease control rate was 70%. Median overall survival and time-to-progression were 5.9 months (95% CI, 3.9–11.3 months) and 3.6 months (95% CI, 2.2–4.2 months), respectively. Grade 3/4 toxicities included leucopenia (35%), neutropenia (35%), anemia (20%), and thrombocytopenia (15%). Two patients treated for approximately 1 year developed cisplatin-related toxicities. In conclusion, gemcitabine and cisplatin combination chemotherapy produces a limited tumor response in BTC, but may prolong patient’s survival.

Keywords

Biliary tract cancer Gemcitabine Cisplatin Refractory 

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
    • 1
  • Yoko Yashima
    • 1
  • Kazumichi Kawakubo
    • 1
  • Hirofumi Kogure
    • 1
  • Osamu Togawa
    • 1
  • Saburo Matsubara
    • 1
  • Naoki Sasahira
    • 1
  • Kenji Hirano
    • 1
  • Takeshi Tsujino
    • 1
  • Minoru Tada
    • 1
  • Masao Omata
    • 1
  • Kazuhiko Koike
    • 1
  1. 1.Department of Gastroenterology, Graduate School of MedicineThe University of TokyoBunkyo-kuJapan