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

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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 0.43–0.98; 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 0.61–1.41; 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.

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Acknowledgments

This study was performed according to the guidelines of the Declaration of Helsinki. The protocol was approved by the institutional review board of participating institutions. Written informed consent was obtained from all patients before their inclusion into the study. This manuscript has not been published and is not under consideration for publication elsewhere.

Conflict of interest

No financial support for this study was provided. The authors report no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Gastroenterology, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 260-8717, Japan

    Kentaro Sudo, Kazuyoshi Nakamura, Taro Hara & Taketo Yamaguchi

  2. Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan

    Takeshi Ishihara, Motohisa Tada, Rintaro Mikata, Katsunobu Tawada & Osamu Yokosuka

  3. Department of Gastroenterology, Kameda Medical Center, Kamogawa, Japan

    Nobuto Hirata & So Nakaji

  4. Department of Hepato-biliary-pancreatic Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan

    Fumiaki Ozawa

  5. Department of Gastroenterology, Saitama Red Cross Hospital, Saitama, Japan

    Tadashi Ohshima

  6. Department of Gastroenterology, Kimitsu Chuo Hospital, Kisarazu, Japan

    Ryosaku Azemoto

  7. Department of Gastroenterology, Asahi General Hospital, Asahi, Japan

    Kenji Shimura

  8. Department of Internal Medicine, Mito Saiseikai General Hospital, Mito, Japan

    Takeshi Nihei

  9. Department of Gastroenterology, Tokyo Women’s Medical University Yachiyo Medical Center, Yachiyo, Japan

    Takayoshi Nishino

  10. Department of Gastroenterology, Numazu City Hospital, Numazu, Japan

    Akihiko Nakagawa

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  1. Kentaro Sudo
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  2. Takeshi Ishihara
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  8. Takeshi Nihei
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  9. Takayoshi Nishino
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  10. Akihiko Nakagawa
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  11. Kazuyoshi Nakamura
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  12. Taro Hara
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  13. Motohisa Tada
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  14. Rintaro Mikata
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  15. Katsunobu Tawada
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  16. Osamu Yokosuka
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  17. So Nakaji
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  18. Taketo Yamaguchi
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Corresponding author

Correspondence to Kentaro Sudo.

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Sudo, K., Ishihara, T., Hirata, N. et al. Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer. Cancer Chemother Pharmacol 73, 389–396 (2014). https://doi.org/10.1007/s00280-013-2368-6

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  • DOI: https://doi.org/10.1007/s00280-013-2368-6

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