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Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer
Authors:Akira Tsuburaya  Naoki Nagata  Haruhiko Cho  Naoki Hirabayashi  Michiya Kobayashi  Hiroshi Kojima  Yasuhiro Munakata  Ryoji Fukushima  Yoichi Kameda  Tadakazu Shimoda  Koji Oba  Junichi Sakamoto
Affiliation:1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi, Yokohama, 2410815, Japan
2. Department of Surgery, Kitakyushu General Hospital, 5-10-10, Yukawa, Kokuraminami, Kitakyusyu, 8000295, Japan
3. Department of Surgery, Hiroshima City Asa Hospital, 2-1-1, Kabeminami, Kita, Hiroshima, 7310293, Japan
4. Department of Surgery, Kochi Medical School, Oko-cho, Kohasu, Nankoku, 7838505, Japan
5. Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, 18, Kurijuku, Kakemachi, Okazaki, 4440011, Japan
6. Department of Surgery, Nagano Municipal Hospital, 1333-1, Toyotake, Nagano, 3818551, Japan
7. Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi, Tokyo, 1738605, Japan
8. Department of Pathology, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi, Yokohama, 2410815, Japan
9. Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji, Chuo, Tokyo, 1040045, Japan
10. Translational Research and Clinical Trial Center, Hokkaido University Hospital, 14 Kita, 5 Nishi, Kita-ku, Sapporo, 0608648, Japan
11. Tokai Central Hospital, 4-6-5 Higashijima, Kakamigahara, 5048601, Japan
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:
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