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Phase II study of S-1 plus oxaliplatin 130 mg/m2 in Japanese patients with advanced gastric cancer

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Abstract

Purpose

Although oxaliplatin 130 mg/m2 every 3 weeks was approved for advanced gastric cancer in Japan, data regarding S-1 plus oxaliplatin 130 mg/m2 (SOX130) are limited in Japanese patients with advanced gastric cancer. We investigated the feasibility and safety of SOX130 in Japanese patients with advanced gastric cancer.

Methods

Patients with unresectable or recurrent gastric adenocarcinoma, no previous chemotherapy, and Eastern Cooperative Oncology Group Performance Status of 0–1 were treated with SOX130. The primary endpoint was the 3-cycle completion rate, defined as the proportion of patients who completed the first three cycles with ≥ 80% relative dose intensity of oxaliplatin.

Results

Twenty-five patients were enrolled from April 2015 to 2016. The 3-cycle completion rate was 72.0% (90% confidence interval: 53.8–86.1), which was higher than the predetermined threshold rate of 50%. With the median number of cycles being 6 (range, 1–19+), grade 3 or 4 adverse events occurred in 10 patients (40%). Major grade 3 adverse events were anorexia (24%), thrombocytopenia (16%), and neutropenia (12%). No febrile neutropenia or treatment-related deaths occurred. Among 12 patients with measurable lesions, the overall response rate was 58.3%. Median progression-free and overall survival were 5.7 months (95% confidence interval 2.9–8.5) and 13.1 months (95% confidence interval 7.4–19.0), respectively.

Conclusion

Results indicated that SOX130 was feasible in Japanese patients with advanced gastric cancer.

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Acknowledgements

This study was supported by the Clinical Research Center of Shizuoka Cancer Center. We thank the patients and their families for their participation in this study. We also thank Misako Kama from the Data Center of Shizuoka Cancer Center for data management.

Funding

No funding was received.

Author information

Authors and Affiliations

  1. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Yosuke Kito, Nozomu Machida, Satoshi Hamauchi, Takahiro Tsushima, Akiko Todaka, Tomoya Yokota, Kentaro Yamazaki, Akira Fukutomi & Hirofumi Yasui

  2. Department of Medical Oncology, Ishikawa Prefectural Central Hospital, 2-1, Kuratsuki-higashi, Kanazawa, Ishikawa, 920-8530, Japan

    Yosuke Kito, Yusuke Onozawa & Kunihiro Tsuji

  3. Division of Clinical Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Sadayuki Kawai

  4. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, 2-1, Kuratsuki-higashi, Kanazawa, Ishikawa, 920-8530, Japan

    Hisashi Doyama

  5. First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki, 889-1692, Japan

    Yutaka Haraguchi & Koji Nakashima

  6. Department of Medical Oncology, Saku Central Hospital Advanced Care Center, 3400-28 Nakagomi, Saku, Nagano, 385-0051, Japan

    Kenji Kunieda

  7. Division of Medical Oncology, Shizuoka General Hospital, 4-27-1 Kita-ando, Aoi-ku, Shizuoka, 420-8527, Japan

    Keisei Taku

  8. Clinical Research Promotion Unit, Clinical Research Center, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Keita Mori

Authors
  1. Yosuke Kito
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  2. Nozomu Machida
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  6. Akiko Todaka
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  8. Kentaro Yamazaki
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  9. Akira Fukutomi
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  10. Yusuke Onozawa
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  11. Kunihiro Tsuji
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  12. Hisashi Doyama
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  13. Yutaka Haraguchi
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  16. Keisei Taku
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  17. Keita Mori
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  18. Hirofumi Yasui
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Corresponding author

Correspondence to Yosuke Kito.

Ethics declarations

Conflict of interest

Yosuke Kito declares that he has no conflict of interest. Nozomu Machida declares that he has no conflict of interest. Sadayuki Kawai declares that he has no conflict of interest. Satoshi Hamauchi declares that he has no conflict of interest. Takahiro Tsushima received honoraria from Chugai Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical, and Ono Pharmaceutical. Akiko Todaka declares that she has no conflict of interest. Tomoya Yokota declares that he has no conflict of interest. Kentaro Yamazaki received honoraria from Yakult Honsha and Taiho Pharmaceutical. Akira Fukutomi declares that he has no conflict of interest. Yusuke Onozawa declares that he has no conflict of interest. Kunihiro Tsuji declares that he has no conflict of interest. Hisashi Doyama declares that he has no conflict of interest. Yutaka Haraguchi declares that he has no conflict of interest. Koji Nakashima declares that he has no conflict of interest. Kenji Kunieda declares that he has no conflict of interest. Keisei Taku declares that he has no conflict of interest. Keita Mori declares that he has no conflict of interest. Hirofumi Yasui declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and the 1964 Helsinki declaration and its later amendments, or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Cite this article

Kito, Y., Machida, N., Kawai, S. et al. Phase II study of S-1 plus oxaliplatin 130 mg/m2 in Japanese patients with advanced gastric cancer. Int J Clin Oncol 23, 1084–1089 (2018). https://doi.org/10.1007/s10147-018-1308-1

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  • DOI: https://doi.org/10.1007/s10147-018-1308-1

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