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Japanese Journal of Clinical Oncology Advance Access published online on March 1, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl138
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© 2007 Foundation for Promotion of Cancer Research

Dose Escalation Study of Nedaplatin with 5-Fluorouracil in Combination with Alternating Radiotherapy in Patients with Head and Neck Cancer

Nobukazu Fuwa1,, Takesi Kodaira1, Hiroyuki Tachibana1, Tatsuya Nakamura1 and Takasi Daimon2

1 Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya
2 Division of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan

For reprints and all correspondence: Nobukazu Fuwa, 1-1 Kanokoden, Chikusaku, Nagoya, 464-8681, Japan. E-mail: nfuwa{at}aichi-cc.jp

Received July 19, 2006; accepted October 13, 2006

Background: This study, with a large number of patients, confirms that after administration of 5-fluorouracil (5FU), a higher dose of nedaplatin (NDP) can be safely administered rather than a single therapy of NDP, as demonstrated in a phase I study.

Methods: The subjects were 52 patients with stage II–IV (M0) head and neck cancer other than nasopharyngeal cancer. Alternating chemoradiotherapy was performed using the following method. Initially, chemotherapy was administered. For chemotherapy, 5FU at 700 mg/m2/24 h was intravenously administered for 5 days (days 1–5), and NDP was administered on day 6. We established three dose groups: level 1, 120 mg/m2; level 2, 140 mg/m2; and level 3, 150 mg/m2 (n = 13 or more per group).

Results: The maximum acceptable dose of NDP (150 mg/m2) was confirmed. The 5-year overall survival rates were 77% (95% CI: 66–90%) in all subjects and 75% (95% CI: 61–92%) in the stage III/IV patients. The 5-year progression-free survival rates were 73% (95% CI: 62–87%) in all subjects and 72% (95% CI: 57–89%) in the stage III/IV patients. Conclusions: After administration of 5FU, a higher dose of NDP can be safely administered. This alternating chemoradiotherapy showed potent antitumor effects. The efficacy of chemotherapy with NDP and 5FU should be compared to that of chemotherapy with CDDP and 5FU.

Key Words: head and neck cancer • alternating chemoradiotherapy • nedaplatin • 5-fluorouracil • radiotherapy


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