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Japanese Journal of Clinical Oncology 2009 39(1):37-42; doi:10.1093/jjco/hyn125
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Phase I Trial of 5-Fluorouracil with Cisplatin and Concurrent Standard-dose Radiotherapy in Japanese Patients with Stage II/III Esophageal Cancer

Takako Eguchi Nakajima1, Takashi Ura2, Yoshinori Ito3, Ken Kato1, Keiko Minashi4, Keiji Nihei5, Shuichi Hironaka6, Narikazu Boku6, Yoshikazu Kagami3 and Kei Muro2

1 Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo
2 Medical Oncology Division, Aichi Cancer Center Hospital, Nagoya
3 Radiology Oncology Division, National Cancer Center Hospital, Tokyo
4 Gastrointestinal Oncology Division, National Cancer Center Hospital East, Chiba
5 Radiology Division, National Cancer Center Hospital East, Chiba
6 Gastrointestinal Oncology Division, Shizuoka Cancer Center, Shizuoka, Japan

For reprints and all correspondence: Takako Eguchi Nakajima, Gastrointestinal Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: taeguchi{at}ncc.go.jp

Received September 8, 2008; accepted October 6, 2008

Objective: In Japan, 5-fluorouracil (5-FU) 400 mg/m2 on Days 1–5, 8–12, 36–40 and 43–46 with cisplatin (CDDP) 40 mg/m2 on Days 1, 8, 36 and 43 plus concurrent radiotherapy with 2 weeks planned interruption (60 Gy) was standard for the patients with esophageal cancer. This Phase I trial was designed to determine the maximal tolerated dose (MTD) and dose-limiting toxicity (DLT) of 5-FU on Days 1–4 and 29–32 with CDDP on Days 1 and 29 plus concurrent radiotherapy (50.4 Gy) among the Japanese.

Methods: Escalating doses of 5-FU and CDDP were administered with concurrent radiotherapy (50.4 Gy). Treatment was continued until DLT appeared.

Results: Twelve patients with previously untreated clinical Stage II/III squamous cell esophageal carcinoma were studied. One of six patients given Level 1 (5-FU 800 mg/m2 on Days 1–4 and 29–32 with CDDP 75 mg/m2 on Days 1 and 29) developed a DLT of incomplete protocol treatment due to Grade 3 esophagitis. The MTD was not reached at Level 2 (5-FU 1000 mg/m2 with CDDP 75 mg/m2). The complete response rate was 67% at Level 1 and 100% at Level 2.

Conclusions: Dose Level 2 with 50.4 Gy radiotherapy was recommended for Japanese patients.

Key Words: esophageal cancer • chemoradiotherapy • 5-fluorouracil • cisplatin • Japanese


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