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Effect of the number of cycles of docetaxel + S-1 therapy on long-term survival in adjuvant chemotherapy for stage III gastric cancer. A pooled analysis of the OGSG0604 and OGSG1002 trials

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Abstract

Background

S-1 plus docetaxel (DS) therapy followed by S-1 is the standard of care in Japan in postoperative adjuvant chemotherapy for stage III gastric cancer, but long-term survival and the number of DS cycles required are unclear. The purpose of this study was to investigate the impact of the number of cycles of DS therapy on the 5-year survival in stage III gastric cancer in a pooled analysis of two phase II trials (OGSG0604 and OGSG1002).

Patients and methods

Patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were enrolled in this pooled analysis. They received DS therapy for four or eight cycles, followed by S-1 until 1 year postgastrectomy. The 5-year overall survival (OS) and the 5-year disease free survival (DFS) by the landmark analysis was evaluated.

Results

In total, 113 patients from the OGSG0604 and OGSG1002 trials were enrolled in this study. The landmark analysis showed a 5-year OS that was better with four to eight cycles of DS therapy than with one to three cycles of DS therapy, with the best 5-year OS of 77.4% (95% confidence interval, 66.5–90.1%) for eight cycles. The 5-year DFS was approximately 66% when four or eight cycles of DS therapy were given.

Conclusion

Although eight cycles of DS therapy may prolong prognosis, the present study did not provide a clear conclusion as to how many DS therapy cycles are needed to improve prognosis after D2 gastrectomy for stage III gastric cancer.

Trial registration

Registration number: UMIN00000714 and UMIN000004440.

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Data availability

Data is available upon reasonable request.

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Acknowledgements

We thank Dr. Yoshihiro Matsubara from the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) for data management. We thank all the patients, investigators, and medical staff who participated in this study as well as the OGSG data center for their contribution. We thank Robert Blakytny, DPhil, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.

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Authors and Affiliations

  1. Department of Surgery, Kindai University Nara Hospital, 1248-1 Otoda-Cho, Ikoma, Nara, 630-0293, Japan

    Yutaka Kimura

  2. Department of Medical Oncology, Kindai University, Faculty of Medicine, Osaka-Sayama, Japan

    Hisato Kawakami

  3. Department of Surgery, Yao Municipal Hospital, Yao, Japan

    Shigeyuki Tamura

  4. Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan

    Kazumasa Fujitani

  5. Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan

    Jin Matsuyama

  6. Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan

    Hiroshi Imamura

  7. Department of Nutritional Oncology, Osaka International Cancer Institute, Osaka, Japan

    Shohei Iijima

  8. Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan

    Daisuke Sakai & Taroh Satoh

  9. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan

    Yukinori Kurokawa

  10. Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan

    Toshio Shimokawa

  11. Department of Surgery, Izumi City General Hospital, Izumi, Japan

    Toshimasa Tsujinaka

  12. Department of Surgery, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan

    Hiroshi Furukawa

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  1. Yutaka Kimura
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  2. Hisato Kawakami
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  3. Shigeyuki Tamura
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  4. Kazumasa Fujitani
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Contributions

Study concept: YK, HK, ST, and KF; study design: YK, HK, ST, and KF; acquisition of data: YK, ST, KF, JM, HI, and SI; statistical analysis of data: TS; analysis and/or interpretation of data: YK, HK, ST, KF, and TS; drafting the manuscript: YK; revising the manuscript critically for important intellectual content: YK, HK, ST, KF, DS, YK, TT, HF, and TS. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Yutaka Kimura.

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Conflict of interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Y. Ki. was supported by grants and personal fees from Daiichi Sankyo Co. Ltd., outside the submitted work. H. K. has received fees and research funding from Bristol-Myers Squibb Co. Ltd., Taiho pharmaceutical Co. Ltd., Eisai Co. Ltd., and Kobayashi Pharmaceutical. Co., Ltd. as well as honoraria and lecture fees from Bristol-Myers Squibb Co. Ltd., Bayer Yakuhin Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Merck Biopharma Co., Ltd., Teijin Pharma Ltd., Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co. Ltd. K. F. has received honoraria and lecture fees from Taiho Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Bristol-Myers Squibb Co. Ltd., Ono Pharmaceutical Co. Ltd., and Yakult Honsha Co. Ltd., outside the submitted work. H. I. has received honoraria and lecture fees from Taiho Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co. Ltd. outside the submitted work. Y. Ku has received research funding from Yakult Honsha Co. Ltd. and Taiho Pharmaceutical Co. Ltd. and lecture fees from Yakult Honsha Co. Ltd., Taiho Pharmaceutical Co. Ltd., and Nippon Kayaku Co. Ltd. outside of the submitted work. T. Sa. has received fees and research funding from Bristol-Myers Squibb Co. Ltd., T Ono Pharmaceutical Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., Daiichi-Sankyo Co. Ltd., Chugai Pharmaceutical Co. Ltd., Yakult Honsha Co. Ltd., and HUTCHMED Ltd., as well as honoraria and lecture fees from Bristol-Myers Squibb Co. Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and Daiichi-Sankyo Co. Ltd.. All remaining authors have declared no conflicts of interest.

Human rights statement and informed consent

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. All patients provided written informed consent.

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Kimura, Y., Kawakami, H., Tamura, S. et al. Effect of the number of cycles of docetaxel + S-1 therapy on long-term survival in adjuvant chemotherapy for stage III gastric cancer. A pooled analysis of the OGSG0604 and OGSG1002 trials. Gastric Cancer 26, 788–797 (2023). https://doi.org/10.1007/s10120-023-01408-y

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