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

  • Kentaro Sudo
  • Takeshi Ishihara
  • Nobuto Hirata
  • Fumiaki Ozawa
  • Tadashi Ohshima
  • Ryosaku Azemoto
  • Kenji Shimura
  • Takeshi Nihei
  • Takayoshi Nishino
  • Akihiko Nakagawa
  • Kazuyoshi Nakamura
  • Taro Hara
  • Motohisa Tada
  • Rintaro Mikata
  • Katsunobu Tawada
  • Osamu Yokosuka
  • So Nakaji
  • Taketo Yamaguchi
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

Authors and Affiliations

  • Kentaro Sudo
    • 1
  • Takeshi Ishihara
    • 2
  • Nobuto Hirata
    • 3
  • Fumiaki Ozawa
    • 4
  • Tadashi Ohshima
    • 5
  • Ryosaku Azemoto
    • 6
  • Kenji Shimura
    • 7
  • Takeshi Nihei
    • 8
  • Takayoshi Nishino
    • 9
  • Akihiko Nakagawa
    • 10
  • Kazuyoshi Nakamura
    • 1
  • Taro Hara
    • 1
  • Motohisa Tada
    • 2
  • Rintaro Mikata
    • 2
  • Katsunobu Tawada
    • 2
  • Osamu Yokosuka
    • 2
  • So Nakaji
    • 3
  • Taketo Yamaguchi
    • 1
  1. 1.Department of GastroenterologyChiba Cancer CenterChuo-ku, ChibaJapan
  2. 2.Department of Gastroenterology and Nephrology, Graduate School of MedicineChiba UniversityChibaJapan
  3. 3.Department of GastroenterologyKameda Medical CenterKamogawaJapan
  4. 4.Department of Hepato-biliary-pancreatic Surgery, Saitama Medical CenterSaitama Medical UniversityKawagoeJapan
  5. 5.Department of GastroenterologySaitama Red Cross HospitalSaitamaJapan
  6. 6.Department of GastroenterologyKimitsu Chuo HospitalKisarazuJapan
  7. 7.Department of GastroenterologyAsahi General HospitalAsahiJapan
  8. 8.Department of Internal MedicineMito Saiseikai General HospitalMitoJapan
  9. 9.Department of GastroenterologyTokyo Women’s Medical University Yachiyo Medical CenterYachiyoJapan
  10. 10.Department of GastroenterologyNumazu City HospitalNumazuJapan