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Induction of a Pathological Complete Response by Four Courses of Neoadjuvant Chemotherapy for Gastric Cancer: Early Results of the Randomized Phase II COMPASS Trial

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

Abstract

Background

The prognosis for stage 3 gastric cancer is not satisfactory, even with S-1 adjuvant chemotherapy. A randomized phase II trial was conducted to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) using a two-by-two factorial design for locally advanced gastric cancer. The primary endpoint was overall survival. We clarified the impact of these regimens on the secondary endpoints, including the clinical and pathological responses, chemotherapy-related toxicities, and surgical results.

Methods

Patients received S-1 (80 mg/m2 for 21 days with 1 week’s rest)/cisplatin (60 mg/m2 at day 8) or paclitaxel/cisplatin (80 and 25 mg/m2, respectively, on days 1, 8, and 15 with 1 week’s rest) as neoadjuvant chemotherapy.

Results

Eighty-three patients were assigned to arm A (two courses of SC, n = 21), arm B (four courses of SC, n = 20), arm C (two courses of PC, n = 21), and arm D (four courses of PC, n = 21). Pathological response rate was 43 % in arm A, 40 % in arm B, 29 % in arm C, and 38 % in arm D. Pathological complete response was only observed in arms B (10 %) and D (10 %). Most bone marrow toxicities, nausea, vomiting, alopecia, and fatigue were slightly higher but acceptable in arms B and D. Grade 3/4 surgical morbidities were not commonly observed in all four arms.

Conclusions

Pathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities, regardless of a SC or PC regimen.

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Acknowledgment

This work was supported by Epidemiological & Clinical Research Information Network (ECRIN).

Disclosure

The authors declare no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Takaki Yoshikawa MD, PhD & Aakira Tsuburaya MD

  2. Department of Gastrointestinal Surgery, Hiroshima University, Hiroshima, Japan

    Kazuaki Tanabe MD

  3. Department of Surgery, Osaka General Medical Center, Osaka, Japan

    Kazuhiro Nishikawa MD

  4. Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan

    Yuichi Ito MD

  5. Department of Surgery, Aichi Cancer Center, Aichi Hospital, Okazaki, Japan

    Takanori Matsui MD

  6. Department of Surgery, NTT West Japan Osaka Hospital, Osaka, Japan

    Yutaka Kimura MD, PhD

  7. Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan

    Naoki Hirabayashi MD

  8. Department of Upper Gastrointestinal Surgery, Osaka-Rosai Hospital, Osaka, Japan

    Shoki Mikata MD

  9. Department of Surgery, Wakayama Medical University, Wakayama, Japan

    Makoto Iwahashi MD

  10. Department of Surgery, Teikyo University, Tokyo, Japan

    Ryoji Fukushima MD

  11. Department of Gastroenterological Surgery, Chiba Cancer Center, Chiba, Japan

    Nobuhiro Takiguchi MD

  12. Department of Gastrointestinal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Isao Miyashiro MD

  13. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan

    Satoshi Morita PhD

  14. Data Center, Nonprofit Organization ECRIN, Aichi, Japan

    Yumi Miyashita

  15. Young Leaders’ Program, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Junichi Sakamoto MD

Authors
  1. Takaki Yoshikawa MD, PhD
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  2. Kazuaki Tanabe MD
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  15. Aakira Tsuburaya MD
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  16. Junichi Sakamoto MD
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Corresponding author

Correspondence to Takaki Yoshikawa MD, PhD.

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Yoshikawa, T., Tanabe, K., Nishikawa, K. et al. Induction of a Pathological Complete Response by Four Courses of Neoadjuvant Chemotherapy for Gastric Cancer: Early Results of the Randomized Phase II COMPASS Trial. Ann Surg Oncol 21, 213–219 (2014). https://doi.org/10.1245/s10434-013-3055-x

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  • DOI: https://doi.org/10.1245/s10434-013-3055-x

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