title: Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer.
abstract: OBJECTIVE
  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/m(2)) and cisplatin (25 mg/m(2)) 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.
authors: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi, Yokohama 2410815, Japan. tuburayaa@kcch.jp
authors: Akira
authors: A
authors: Tsuburaya
authors: Naoki
authors: N
authors: Nagata
authors: Haruhiko
authors: H
authors: Cho
authors: Naoki
authors: N
authors: Hirabayashi
authors: Michiya
authors: M
authors: Kobayashi
authors: Hiroshi
authors: H
authors: Kojima
authors: Yasuhiro
authors: Y
authors: Munakata
authors: Ryoji
authors: R
authors: Fukushima
authors: Yoichi
authors: Y
authors: Kameda
authors: Tadakazu
authors: T
authors: Shimoda
authors: Koji
authors: K
authors: Oba
authors: Junichi
authors: J
authors: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin