Japanese Journal of Clinical Oncology 33:297-301 (2003)
© 2003 Foundation for Promotion of Cancer Research
Phase I Study of Weekly Docetaxel Infusion and Concurrent Radiation Therapy for Head and Neck Cancer
1 Department of Radiology and 3 Department of Otolaryngology – Head and Neck Surgery, Kinki University, School of Medicine, Osaka Sayama, Osaka, and 2 Radiation Oncology Research Laboratory, Research Reactor Institute, Kyoto University, Sennan-gun, Osaka, Japan
Objective: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel in combination with concurrent radiotherapy for treating head and neck cancer.
Methods: Twelve patients with unresectable or postoperative head and neck cancers were enrolled in a dose-escalating phase I study. Eleven of the 12 patients were postoperative patients with intermediate or high pathological risk features. Radiotherapy was delivered as a standard fractionation regimen (2 Gy/day, 5 fractions/week) to a total dose of 60–70 Gy. The starting dose of docetaxel was 10 mg/m2 (once per week) with a subsequent dose escalation of 5 mg/m2 in cohorts of three patients. In 2001 and 2002, 12 patients completing three dose levels were included in the study.
Results: The MTD of docetaxel was 20 mg/m2. With the third dose level (20 mg/m2), DLT was observed in two of three patients. One experienced grade IV mucositis and another suffered from prolonged grade III mucositis-enforced treatment delay for 13 days. Hematological toxicity was minimal. Mucositis was the DLT of concurrent chemoradiotherapy using weekly docetaxel administration for head and neck cancer.
Conclusions: We identified the recommended phase II dose of docetaxel as 15 mg/m2 administered weekly with concurrent radiotherapy for head and neck cancers.
+ For reprints and all correspondence: Minoru Suzuki, Radiation Oncology Research Laboratory, Research Reactor Institute, Kyoto University, Noda, Kumatori-cho, Sennan-gun, Osaka 590-0494, Japan. E-mail: msuzuki{at}rri.kyoto-u.ac.jp
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