Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 5, pp 1309–1314

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

Authors

    • Department of Gastrointestinal SurgeryKanagawa Cancer Center
  • Naoki Nagata
    • Department of SurgeryKitakyushu General Hospital
  • Haruhiko Cho
    • Department of Gastrointestinal SurgeryKanagawa Cancer Center
  • Naoki Hirabayashi
    • Department of SurgeryHiroshima City Asa Hospital
  • Michiya Kobayashi
    • Department of SurgeryKochi Medical School
  • Hiroshi Kojima
    • Department of Gastroenterological SurgeryAichi Cancer Center Aichi Hospital
  • Yasuhiro Munakata
    • Department of SurgeryNagano Municipal Hospital
  • Ryoji Fukushima
    • Department of SurgeryTeikyo University School of Medicine
  • Yoichi Kameda
    • Department of PathologyKanagawa Cancer Center
  • Tadakazu Shimoda
    • Center for Cancer Control and Information ServicesNational Cancer Center
  • Koji Oba
    • Translational Research and Clinical Trial CenterHokkaido University Hospital
  • Junichi Sakamoto
    • Tokai Central Hospital
Original Article

DOI: 10.1007/s00280-013-2130-0

Cite this article as:
Tsuburaya, A., Nagata, N., Cho, H. et al. Cancer Chemother Pharmacol (2013) 71: 1309. doi:10.1007/s00280-013-2130-0

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

CisplatinGastric cancerNeoadjuvant chemotherapyPaclitaxelPathological response

Copyright information

© Springer-Verlag Berlin Heidelberg 2013