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Phase 2 Trial of Adjuvant Chemotherapy With S − 1 for Node-Positive Biliary Tract Cancer (N-SOG 09)

  • Hepatobiliary Tumors
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Nodal metastasis is a leading attributable factor of poor survival in biliary tract cancer (BTC), and adjuvant chemotherapy targeting this high-risk feature has not been attempted to date. This study aimed to test the efficacy of adjuvant S − 1 for patients with node-positive BTC.

Methods

This single-arm multicenter phase 2 trial enrolled patients who underwent resection for histologically proven node-positive BTC. In this trial, S − 1 was administered at a dose of 80–120 mg/day on 14 days of a tri-weekly cycle for 6 months. The primary end point of the trial was 3-year overall survival (OS), in which the result would be promising if the 90% confidence interval (CI) surpassed a threshold of 30% (alpha error, 0.1; beta error, 0.2). The secondary end points were relapse-free survival (RFS), feasibility, and toxicity.

Results

The trial included 50 patients with perihilar (n = 23) or distal (n = 20) cholangiocarcinoma, or gallbladder cancer (n = 7). The median numbers of positive lymph nodes and examined lymph nodes were respectively 2 and 15. The 3-year OS and RFS were respectively 50% (90% CI, 40.9–59.1%) and 32.0% (95% CI, 19.1–44.9%), with median survival times of 34.6 months (95% CI, 19.3–49.8 months) and 18.4 months (95% CI, 11.9–24.9 months). Although hematologic toxicity often occurred, grades 3 and 4 toxicity were rare. The completion rate of the test therapy was 64%, and the median relative dose intensity was 87.5% (interquartile range, 50–100%).

Conclusion

Adjuvant chemotherapy with S − 1 may be promising for patients with node-positive BTC.

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Acknowledgment

The following investigators of the Nagoya Surgical Oncology Group also participated in this study: Satoshi Kobayashi (Kumiai Kosei Hospital, Takayama, Japan), Masahiko Asano (Nishichita General Hospital, Tokai, Japan), Daisuke Takara (Kiryu Kosei General Hospital, Kiryu, Japan), Keita Itatsu (Kamiiida Daiichi General Hospital, Nagoya, Japan), and Eiji Hayashi (Chukyo Hospital, Nagoya, Japan).

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Authors and Affiliations

  1. Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Kazuaki Seita MD, Tomoki Ebata MD, PhD, Takashi Mizuno MD, PhD & Masato Nagino MD, PhD

  2. Department of Surgery, Ogaki Municipal Hospital, Ogaki, Japan

    Atsuyuki Maeda MD, PhD

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

    Ryuzo Yamaguchi MD, PhD

  4. Department of Surgery, Toyota Kosei Hospital, Toyota, Japan

    Yasuhiro Kurumiya MD, PhD

  5. Department of Surgery, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan

    Eiji Sakamoto MD, PhD

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

    Kazuhiro Hiramatsu MD, PhD

  7. Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan

    Masahiko Ando MD, PhD

Authors
  1. Kazuaki Seita MD
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  2. Tomoki Ebata MD, PhD
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  3. Takashi Mizuno MD, PhD
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  4. Atsuyuki Maeda MD, PhD
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  5. Ryuzo Yamaguchi MD, PhD
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  10. Masato Nagino MD, PhD
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Corresponding author

Correspondence to Tomoki Ebata MD, PhD.

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Disclosures

Masahiko Ando has received grants from Kyowa Kirin Co. Ltd. The remaining authors have no conflicts of interest.

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Seita, K., Ebata, T., Mizuno, T. et al. Phase 2 Trial of Adjuvant Chemotherapy With S − 1 for Node-Positive Biliary Tract Cancer (N-SOG 09). Ann Surg Oncol 27, 2348–2356 (2020). https://doi.org/10.1245/s10434-020-08355-3

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  • DOI: https://doi.org/10.1245/s10434-020-08355-3

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