Cancer Chemotherapy and Pharmacology

, Volume 73, Issue 2, pp 389–396

Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer

Authors

    • Department of GastroenterologyChiba Cancer Center
  • Takeshi Ishihara
    • Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba University
  • Nobuto Hirata
    • Department of GastroenterologyKameda Medical Center
  • Fumiaki Ozawa
    • Department of Hepato-biliary-pancreatic Surgery, Saitama Medical CenterSaitama Medical University
  • Tadashi Ohshima
    • Department of GastroenterologySaitama Red Cross Hospital
  • Ryosaku Azemoto
    • Department of GastroenterologyKimitsu Chuo Hospital
  • Kenji Shimura
    • Department of GastroenterologyAsahi General Hospital
  • Takeshi Nihei
    • Department of Internal MedicineMito Saiseikai General Hospital
  • Takayoshi Nishino
    • Department of GastroenterologyTokyo Women’s Medical University Yachiyo Medical Center
  • Akihiko Nakagawa
    • Department of GastroenterologyNumazu City Hospital
  • Kazuyoshi Nakamura
    • Department of GastroenterologyChiba Cancer Center
  • Taro Hara
    • Department of GastroenterologyChiba Cancer Center
  • Motohisa Tada
    • Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba University
  • Rintaro Mikata
    • Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba University
  • Katsunobu Tawada
    • Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba University
  • Osamu Yokosuka
    • Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba University
  • So Nakaji
    • Department of GastroenterologyKameda Medical Center
  • Taketo Yamaguchi
    • Department of GastroenterologyChiba Cancer Center
Original Article

DOI: 10.1007/s00280-013-2368-6

Cite this article as:
Sudo, K., Ishihara, T., Hirata, N. et al. Cancer Chemother Pharmacol (2014) 73: 389. doi:10.1007/s00280-013-2368-6

Abstract

Purpose

The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer.

Methods

Patients were randomly assigned to receive GS (oral S-1 60 mg/m2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m2 on days 8 and 15) or gemcitabine (1,000 mg/m2 on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS).

Results

One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.430.98; P = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.611.41; P = 0.714). Grade 3–4 neutropenia (44 vs 19.6 %, P = 0.011) and thrombocytopenia (26 vs 8.7 %, P = 0.051) were more frequent in the GS arm.

Conclusions

GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.

Keywords

Pancreatic cancerS-1GemcitabineRandomized controlled study

Copyright information

© Springer-Verlag Berlin Heidelberg 2013