Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 4, pp 973–979 | Cite as

A randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine monotherapy for advanced biliary tract cancer

  • Takashi Sasaki
  • Hiroyuki Isayama
  • Yousuke Nakai
  • Yukiko Ito
  • Ichiro Yasuda
  • Nobuo Toda
  • Hirofumi Kogure
  • Keiji Hanada
  • Hiroyuki Maguchi
  • Naoki Sasahira
  • Hideki Kamada
  • Tsuyoshi Mukai
  • Yoshihiro Okabe
  • Osamu Hasebe
  • Iruru Maetani
  • Kazuhiko Koike
Original Article

Abstract

Purpose

In order to confirm the impact of adding S-1 to gemcitabine, we conducted a randomized phase II study to compare the combination therapy of gemcitabine plus S-1 to gemcitabine monotherapy in patients with advanced biliary tract cancer.

Methods

Sixty-two patients with advanced cholangiocarcinoma or gallbladder cancer were randomized to either the combination therapy of gemcitabine and S-1 (gemcitabine 1,000 mg/m2 on days 1 and 15 and S-1 40 mg/m2 b.i.d. on days 1–14, repeated every 4 weeks) or gemcitabine monotherapy (gemcitabine 1,000 mg/m2 on days 1, 8, and 15, repeated every 4 weeks). The primary endpoint of this study was response rate, and the regimen which showed the better response rate was selected as a candidate of phase III study. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria version 1.0.

Results

The response rates of the combination therapy and the monotherapy were 20.0 and 9.4 %, respectively. The median time-to-progressions and overall survivals of these two treatments were nearly the same (5.6 vs. 4.3 months; 8.9 vs. 9.2 months). Adverse events occurred more frequently in the combination arm.

Conclusions

The combination therapy of gemcitabine and S-1 showed the better response rate, but the superiority of this combination therapy was not clear in total. Because the standard of care changed to the combination therapy with gemcitabine and cisplatin during this study, it is difficult to select this combination therapy with a 4-week regimen as a candidate of phase III study.

Keywords

Biliary tract cancer Gemcitabine S-1 Chemotherapy Randomized control study 

Notes

Acknowledgments

We thank all the patients participated in this study, their families, and the investigators.

Conflict of interest

None.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Takashi Sasaki
    • 1
  • Hiroyuki Isayama
    • 1
  • Yousuke Nakai
    • 1
  • Yukiko Ito
    • 2
  • Ichiro Yasuda
    • 3
  • Nobuo Toda
    • 4
  • Hirofumi Kogure
    • 5
  • Keiji Hanada
    • 6
  • Hiroyuki Maguchi
    • 7
  • Naoki Sasahira
    • 8
  • Hideki Kamada
    • 9
  • Tsuyoshi Mukai
    • 10
  • Yoshihiro Okabe
    • 11
  • Osamu Hasebe
    • 12
  • Iruru Maetani
    • 13
  • Kazuhiko Koike
    • 1
  1. 1.Department of Gastroenterology, Graduate School of MedicineThe University of TokyoTokyoJapan
  2. 2.Department of GastroenterologyJapanese Red Cross Medical CenterTokyoJapan
  3. 3.First Department of Internal MedicineGifu University HospitalGifuJapan
  4. 4.Department of GastroenterologyMitsui Memorial HospitalTokyoJapan
  5. 5.Department of GastroenterologyKanto Central HospitalTokyoJapan
  6. 6.Center for GastroendoscopyOnomichi General HospitalOnomichiJapan
  7. 7.Center for GastroenterologyTeine-Keijinkai HospitalSapporoJapan
  8. 8.Department of GastroenterologyJR Tokyo General HospitalTokyoJapan
  9. 9.Department of Gastroenterology and NeurologyKagawa University School of MedicineTakamatsuJapan
  10. 10.Department of GastroenterologyGifu Municipal HospitalGifuJapan
  11. 11.Department of GastroenterologyOsaka Red Cross HospitalOsakaJapan
  12. 12.Department of GastroenterologyNagano Municipal HospitalNaganoJapan
  13. 13.Department of GastroenterologyToho University Ohashi Medical CenterTokyoJapan

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