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Neoadjuvant chemotherapy plus surgery for high-risk advanced gastric cancer: long-term results of KDOG1001 trial

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Abstract

Purpose

The purpose of this study is to evaluate the long-term survival outcomes of KDOG1001 trial after a minimum follow-up of 3 years.

Methods

Patients with bulky N2 lymph nodes, linitis plastica (type 4), or large ulcero-invasive-type tumors (type 3) received up to four 28-day cycles of DCS neoadjuvant chemotherapy (docetaxel at 40 mg/m2, cisplatin at 60 mg/m2 on day 1, and S-1 at 40 mg/m2 twice daily for 2 weeks) followed by gastrectomy with D2 lymphadenectomy plus adjuvant S-1 therapy for 1 year. The final preplanned analysis of long-term outcomes including overall survival and relapse-free survival was conducted after minimum follow-up of 3 years. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN 000003642, and has been completed.

Results

From May 2010 through January 2017, 40 patients were enrolled. All included patients underwent neoadjuvant chemotherapy with DCS followed by gastrectomy with D2 lymphadenectomy, and 32 (80%) completed adjuvant S-1 therapy for 1 year. After a median follow-up for surviving patients of 68 months at the last follow-up in January 2020, 3-year overall survival rate was 77.5% (95% confidence interval 62.1–87.9%), while 3-year relapse-free survival rate was 62.5% (95% confidence interval 46.8–76.0%).

Conclusion

Neoadjuvant chemotherapy with 4 cycles of DCS followed by D2 gastrectomy plus adjuvant S-1 was associated with relatively good long-term oncologic outcomes for patients with the high-risk gastric cancer.

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Authors and Affiliations

Authors

Contributions

Satoshi Tanabe, Wasaburo Koizumi, and Keishi Yamashita are responsible for the study conception and design; Kei Hosoda, Chikatoshi Katada, Kenji Ishido, Hideki Ushiku, Hiroki Harada, Mikiko Sakuraya, Marie Washio Takuya Wada, Akinori Watanabe Satoshi Tanabe, Wasaburo Koizumi, and Keishi Yamashita for the acquisition of data; Kei Hosoda, Keishi Yamashita, and Naoki Hiki for the analysis and interpretation of data; Kei Hosoda and Naoki Hiki for the drafting; and Masahiro Niihara, Takeo Sato, Hiroshi Tajima, Takashi Kaizu, Yoshimasa Kosaka, Hiroshi Kato, Norihiko Sengoku, Kiyoshi Tanaka, Takeshi Naito, Yusuke Kumamoto, Takafumi Sangai, Satoshi Tanabe, Wasaburo Koizumi, Keishi Yamashita, and Naoki Hiki for the critical revision of the manuscript.

Corresponding author

Correspondence to Kei Hosoda.

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All procedures performed in studies involving human participants were 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.

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

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Hosoda, K., Katada, C., Ishido, K. et al. Neoadjuvant chemotherapy plus surgery for high-risk advanced gastric cancer: long-term results of KDOG1001 trial. Langenbecks Arch Surg 405, 777–785 (2020). https://doi.org/10.1007/s00423-020-01924-w

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  • DOI: https://doi.org/10.1007/s00423-020-01924-w

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