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Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer

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Abstract

Purpose

Paclitaxel–cisplatin (TC) combination is effective and well tolerated in patients with unresectable gastric cancer. We investigated the efficacy and safety of TC for locally advanced gastric cancers in a neoadjuvant setting.

Methods

Patients received 2–4 courses of paclitaxel (80 mg/m2) and cisplatin (25 mg/m2) on days 1, 8, and 15 in a 4-weekly schedule, followed by radical gastrectomy. Primary endpoint was the pathological response rate: percentage of tumors in which one-third or more parts were affected.

Results

All 52 patients enrolled were eligible. Thirty-six (69.7 %) patients completed two or more courses of chemotherapy. Forty-three patients (82.7 %) underwent surgery, 33 (63.5 %) had R0 resection, and there was no treatment-related death. The pathological response was 34.6 % (95 % CI 22.0–49.1) for all registered patients; the null hypothesis of tumor response ≤10 % was rejected (p < 0.0001). The 3-year overall survival was 41.5 % (95 % CI 27.4–55.0).

Conclusions

The neoadjuvant chemotherapy with TC was safe and effective for patients with locally advanced gastric cancer, and further study is needed to confirm the effectiveness of this regimen.

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Acknowledgments

This work was supported by the non-profit organization Epidemiological & Clinical Research Information Network.

Conflict of interest

  All authors declared no conflict of interests.

Author information

Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi, Yokohama, 2410815, Japan

    Akira Tsuburaya & Haruhiko Cho

  2. Department of Surgery, Kitakyushu General Hospital, 5-10-10, Yukawa, Kokuraminami, Kitakyusyu, 8000295, Japan

    Naoki Nagata

  3. Department of Surgery, Hiroshima City Asa Hospital, 2-1-1, Kabeminami, Kita, Hiroshima, 7310293, Japan

    Naoki Hirabayashi

  4. Department of Surgery, Kochi Medical School, Oko-cho, Kohasu, Nankoku, 7838505, Japan

    Michiya Kobayashi

  5. Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, 18, Kurijuku, Kakemachi, Okazaki, 4440011, Japan

    Hiroshi Kojima

  6. Department of Surgery, Nagano Municipal Hospital, 1333-1, Toyotake, Nagano, 3818551, Japan

    Yasuhiro Munakata

  7. Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi, Tokyo, 1738605, Japan

    Ryoji Fukushima

  8. Department of Pathology, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi, Yokohama, 2410815, Japan

    Yoichi Kameda

  9. Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji, Chuo, Tokyo, 1040045, Japan

    Tadakazu Shimoda

  10. Translational Research and Clinical Trial Center, Hokkaido University Hospital, 14 Kita, 5 Nishi, Kita-ku, Sapporo, 0608648, Japan

    Koji Oba

  11. Tokai Central Hospital, 4-6-5 Higashijima, Kakamigahara, 5048601, Japan

    Junichi Sakamoto

Authors
  1. Akira Tsuburaya
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  2. Naoki Nagata
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  3. Haruhiko Cho
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  4. Naoki Hirabayashi
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  5. Michiya Kobayashi
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  6. Hiroshi Kojima
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  7. Yasuhiro Munakata
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  8. Ryoji Fukushima
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  9. Yoichi Kameda
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  10. Tadakazu Shimoda
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  11. Koji Oba
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  12. Junichi Sakamoto
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Corresponding author

Correspondence to Akira Tsuburaya.

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Tsuburaya, A., Nagata, N., Cho, H. et al. Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer. Cancer Chemother Pharmacol 71, 1309–1314 (2013). https://doi.org/10.1007/s00280-013-2130-0

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  • DOI: https://doi.org/10.1007/s00280-013-2130-0

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