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A Phase 2 Study of Induction Chemotherapy Using Docetaxel, Cisplatin, and S-1 for Gastric Cancer with Peritoneal Metastasis (KUGC06)

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

Abstract

Background

The authors previously showed the significant efficacy of S-1 plus cisplatin for gastric cancer with limited peritoneal metastasis. They conducted a phase 2 study to evaluate the safety and efficacy of induction chemotherapy using a docetaxel, cisplatin, and S-1 (DCS) triplet regimen to treat gastric cancer with peritoneal metastasis.

Methods

The key eligibility criteria were gastric cancer with peritoneal metastasis or positive peritoneal cytology but no other distant metastases and capability of oral administration. The patients received three 28-day cycles of DCS (60 mg/m2 of cisplatin, 40 mg/m2 of docetaxel on day 1, and 80 mg/m2 of S-1 from day 1 to day 14), then underwent D2 gastrectomy if R0 was possible. The primary end point was the R0 resection rate. The sample size was determined to have 80% power for detecting a 20% improvement in the R0 resection rate over a 45% baseline for a one-tailed alpha of 0.1.

Results

Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28–66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%.

Conclusions

Induction chemotherapy with DCS is safe and can achieve R0 resection for some patients with limited peritoneal metastasis or positive peritoneal cytology. The efficacy, however, appears similar to that of S-1 plus cisplatin.

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Acknowledgment

The authors thank Yuriko Hayashi for data collection and management, and all members of KUSOG who participated in this multicenter study. This work was supported by operating support Grants from Kyoto University.

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Authors and Affiliations

  1. Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan

    Hiroshi Okabe MD, PhD, Nobuaki Hoshino MD, PhD, Shigeo Hisamori MD, PhD, Shigeru Tsunoda MD, PhD, Kazutaka Obama MD, PhD & Yoshiharu Sakai MD, PhD

  2. Department of Gastroenterological Surgery, New Tokyo Hospital, Matsudo, Japan

    Hiroshi Okabe MD, PhD

  3. Department of Surgery, Kyoto Medical Center, Kyoto, Japan

    Hiroaki Hata MD, PhD

  4. Department of Surgery, Kyoto City Hospital, Kyoto, Japan

    Hisahiro Hosogi MD, PhD

  5. Department of Surgery, Osaka Red Cross Hospital, Osaka, Japan

    Hisahiro Hosogi MD, PhD

  6. Department of Gastroenterological Surgery, Kitano Hospital, Osaka, Japan

    Shugo Ueda MD, PhD

  7. Department of Surgery, Saiseikai Noe Hospital, Osaka, Japan

    Shuji Ota MD

  8. Department of Surgery, Toyooka Hospital, Toyooka, Japan

    Yousuke Kinjo MD, PhD

  9. Department of Surgery, Himeji Medical Center for Adults, Himeji, Japan

    Yousuke Kinjo MD, PhD

Authors
  1. Hiroshi Okabe MD, PhD
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  2. Hiroaki Hata MD, PhD
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  3. Hisahiro Hosogi MD, PhD
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  4. Shugo Ueda MD, PhD
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  5. Shuji Ota MD
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  6. Yousuke Kinjo MD, PhD
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  7. Nobuaki Hoshino MD, PhD
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  8. Shigeo Hisamori MD, PhD
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  9. Shigeru Tsunoda MD, PhD
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  10. Kazutaka Obama MD, PhD
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  11. Yoshiharu Sakai MD, PhD
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Consortia

The Kyoto University Surgical Oncology Group (KUSOG)

Corresponding author

Correspondence to Hiroshi Okabe MD, PhD.

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Okabe, H., Hata, H., Hosogi, H. et al. A Phase 2 Study of Induction Chemotherapy Using Docetaxel, Cisplatin, and S-1 for Gastric Cancer with Peritoneal Metastasis (KUGC06). Ann Surg Oncol 26, 1779–1786 (2019). https://doi.org/10.1245/s10434-019-07229-7

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  • DOI: https://doi.org/10.1245/s10434-019-07229-7

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