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

  • Akira Tsuburaya
  • Naoki Nagata
  • Haruhiko Cho
  • Naoki Hirabayashi
  • Michiya Kobayashi
  • Hiroshi Kojima
  • Yasuhiro Munakata
  • Ryoji Fukushima
  • Yoichi Kameda
  • Tadakazu Shimoda
  • Koji Oba
  • Junichi Sakamoto
Original Article

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 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Akira Tsuburaya
    • 1
  • Naoki Nagata
    • 2
  • Haruhiko Cho
    • 1
  • Naoki Hirabayashi
    • 3
  • Michiya Kobayashi
    • 4
  • Hiroshi Kojima
    • 5
  • Yasuhiro Munakata
    • 6
  • Ryoji Fukushima
    • 7
  • Yoichi Kameda
    • 8
  • Tadakazu Shimoda
    • 9
  • Koji Oba
    • 10
  • Junichi Sakamoto
    • 11
  1. 1.Department of Gastrointestinal SurgeryKanagawa Cancer CenterYokohamaJapan
  2. 2.Department of SurgeryKitakyushu General HospitalKitakyusyuJapan
  3. 3.Department of SurgeryHiroshima City Asa HospitalHiroshimaJapan
  4. 4.Department of SurgeryKochi Medical SchoolNankokuJapan
  5. 5.Department of Gastroenterological SurgeryAichi Cancer Center Aichi HospitalOkazakiJapan
  6. 6.Department of SurgeryNagano Municipal HospitalNaganoJapan
  7. 7.Department of SurgeryTeikyo University School of MedicineTokyoJapan
  8. 8.Department of PathologyKanagawa Cancer CenterYokohamaJapan
  9. 9.Center for Cancer Control and Information ServicesNational Cancer CenterTokyoJapan
  10. 10.Translational Research and Clinical Trial CenterHokkaido University HospitalSapporoJapan
  11. 11.Tokai Central HospitalKakamigaharaJapan

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