Original Article

Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 5, pp 1309-1314

First online:

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

  • Akira TsuburayaAffiliated withDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center Email author 
  • , Naoki NagataAffiliated withDepartment of Surgery, Kitakyushu General Hospital
  • , Haruhiko ChoAffiliated withDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center
  • , Naoki HirabayashiAffiliated withDepartment of Surgery, Hiroshima City Asa Hospital
  • , Michiya KobayashiAffiliated withDepartment of Surgery, Kochi Medical School
  • , Hiroshi KojimaAffiliated withDepartment of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital
  • , Yasuhiro MunakataAffiliated withDepartment of Surgery, Nagano Municipal Hospital
  • , Ryoji FukushimaAffiliated withDepartment of Surgery, Teikyo University School of Medicine
  • , Yoichi KamedaAffiliated withDepartment of Pathology, Kanagawa Cancer Center
    • , Tadakazu ShimodaAffiliated withCenter for Cancer Control and Information Services, National Cancer Center
    • , Koji ObaAffiliated withTranslational Research and Clinical Trial Center, Hokkaido University Hospital
    • , Junichi SakamotoAffiliated withTokai Central Hospital

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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.

Keywords

Cisplatin Gastric cancer Neoadjuvant chemotherapy Paclitaxel Pathological response