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Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

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Abstract

Background

Although there is insufficient evidence for the treatment of older patients with advanced gastric cancer, fluorouracil combined with platinum chemotherapy has been recognized as a standard first-line treatment for such populations in Japan despite the lack of efficacy and toxicity data.

Methods

Patients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m2, day 1; S-1: 80 mg/m2, days 1–14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a two-sided alpha value of 5%.

Results

From February 2010 to January 2015, 31 patients were enrolled and assessed for efficacy and toxicity. The response rate was 45.2% (95% CI 27.3%–64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%).

Conclusions

These findings indicate that S-1 plus docetaxel as first-line treatment for older patients is feasible and that it has promising efficacy against advanced gastric cancer.

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Acknowledgements

We thank all the patients and their families. We also thank Hiroshi Furukawa and Toshimasa Tsujinaka for advice on the study conception and design; Toshimasa Tsujinaka for statistical analyses of data; and Akemi Morita for data management. Additionally, we thank H. Nikki March, PhD, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.

Funding

This study was not funded.

Author information

Authors and Affiliations

  1. Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka-city, Japan

    Tomono Kawase & Hiroshi Imamura

  2. Department of Surgery, Sakai City Medical Center, 1-1-1 Ebaraji-cho, Nishi-ku, Sakai-city, Japan

    Ryohei Kawabata & Kazuhiro Nishikawa

  3. Department of Surgery, Osaka Rosai Hospital, 1179-3 Nakasone-cho, Kita-ku, Sakai-city, Japan

    Ryohei Kawabata

  4. Department of Gastroenterological Surgery, Higashiosaka City Medical Center, 3-4-5 Nishiiwata, Higashiosaka-city, Japan

    Jin Matsuyama

  5. Department of Medical Oncology, Kansai Electric Power Hospital, 2-1-7 Fukushima, Fukushima-ku, Osaka-city, Japan

    Kazuhiro Yanagihara

  6. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Japan

    Kazuyoshi Yamamoto & Yukinori Kurokawa

  7. Department of Gastroenterology, Bellland General Hospital, 500-3 Higashiyama, Naka-ku, Sakai-city, Japan

    Noriyuki Hoki

  8. Department of Surgery, Yao Municipal Hospital, 1-3-1 Ryuge-cho, Yao-city, Japan

    Junji Kawada

  9. Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Oonohigashi, Sayama-city, Japan

    Hisato Kawakami

  10. Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka-city, Japan

    Daisuke Sakai

  11. Clinical Study Support Center, Wakayama Medical University, 811-1 Kimiidera, Wakayama-city, Japan

    Toshio Shimokawa

  12. Palliative and Supportive Care Center, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Japan

    Taroh Satoh

Authors
  1. Tomono Kawase
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  2. Hiroshi Imamura
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  3. Ryohei Kawabata
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  4. Jin Matsuyama
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  5. Kazuhiro Nishikawa
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  6. Kazuhiro Yanagihara
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  7. Kazuyoshi Yamamoto
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  8. Noriyuki Hoki
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  9. Junji Kawada
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  10. Hisato Kawakami
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  11. Daisuke Sakai
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  12. Yukinori Kurokawa
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  13. Toshio Shimokawa
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  14. Taroh Satoh
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Contributions

All authors contributed to the study conception and design. Hiroshi Imamura designed and supervised the research. Material preparation, data collection and analysis were performed by TS. The first draft of the manuscript was written by TK, HK: reviewed and modified the manuscript and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Hiroshi Imamura.

Ethics declarations

Conflict of interest

Hiroshi Imamura has received honoraria from Taiho Pharmaceutical Co., Ltd. Kazuhiro Nishikawa has received honoraria from Bristol-Myers Squibb Co., Ltd., Daiichi Sankyo, Co., Ltd., EA Pharma Co., Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. Hisato Kawakami has has received honoraria from BMS K.K., ONO Pharmaceutical Co., LTD., Eli Lilly Japan K.K., MSD K.K., and Daiichi Sankyo, Co., Ltd., fees for promotional materials from ONO Pharmaceutical Co., LTD., üMSD K.K., and Daiichi Sankyo, Co., Ltd., and research funding from BMS K.K., Eisai Co., Ltd., and Kobayashi Pharmaceutical Co. Ltd. Daisuke Sakai has received honoraria from Daiichi Sankyo Co. Ltd., and Chugai Pharmaceutical Co., Ltd., and research funding from Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd., and Taiho Pharmaceutical Co., Ltd. Yukinori Kurokawa has received lecture fees and research grant from Taiho Pharmaceutical Co., Ltd. Taroh Satoh has received honoraria from ONO Pharmaceutical Co., Yakult Honsha Co., Ltd., Chugai Pharmaceutical Co., Eli Lilly Japan K.K., Bristol-Myers Squibb Co. Ltd., MSD K.K., and Taiho Pharmaceutical Co., Ltd., research funding from ONO Pharmaceutical Co., Chugai Pharmaceutical Co., Eli Lilly Japan K.K., Bristol-Myers Squibb Co. Ltd., MSD K.K., Taiho Pharmaceutical Co., Ltd., and Hutch Med Co., Ltd., scholarship donations from Taiho Pharmaceutical Co., Ltd., and endowed chairs from ONO Pharmaceutical Co., Yakult Honsha Co., Ltd., and Chugai Pharmaceutical Co. All the remaining authors have no conflicts of interest to declare.

Ethical approval

All procedures in this study were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants before entry into the study.

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Kawase, T., Imamura, H., Kawabata, R. et al. Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902). Int J Clin Oncol 29, 134–141 (2024). https://doi.org/10.1007/s10147-023-02437-4

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  • DOI: https://doi.org/10.1007/s10147-023-02437-4

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