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Japanese Journal of Clinical Oncology 2007 37(9):641-646; doi:10.1093/jjco/hym101
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© 2007 Foundation for Promotion of Cancer Research

A phase I–II Study of Bi-weekly Docetaxel Combined with Radiation Therapy for Patients with Cancer of the Larynx/hypopharynx

Tomoyuki Yoshida1,, Ryoji Tokashiki2, Hiroyuki Itoh2, Kazuhiro Nakamura1, Hiroyuki Hiramatsu2, Kiyoaki Tsukahara2, Shigetaka Shimizu1, Daisuke Takada2, Isaku Okamoto2, Kimihiko Abe3 and Mamoru Suzuki2

1 Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo
2 Otorhinolaryngology, Tokyo Medical University
3 Radiology, Tokyo Medical University, Tokyo, Japan

For reprints and all correspondence: Tomoyuki Yoshida, Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, 1163 Tatemachi, Hachioji city, Tokyo 193-0998, Japan. Hachioji, Tokyo. E-mail: jibitom{at}tokyo-med.ac.jp

Received January 13, 2007; accepted May 21, 2007

Background: We performed a phase I/IIstudy of bi-weekly docetaxel in combination with concurrent radiotherapy to enhance the cytotoxic effect and radiosensitization and improve the rate of laryngeal preservation.

Methods: Patients with T2N0-1M0, T3N0M0 hypopharyngeal cancer or T2N0-1M0, T3N0-1M0 larynx cancer were enrolled. Docetaxel was administered bi-weekly (days 1, 15, 29) from the first day of radiotherapy, while 2 Gy/day of radiation was given on 5 days weekly from day 1, reaching a total of 60 Gy in 30 fractions.

Results: 12 patients took part in the phase I study. The maximum tolerated dose (MTD) was 40 mg/m2 and the recommended dose (RD) was determined as 35 mg/m2. The phase II study was conducted with docetaxel at 35 mg/m2 for 25 patients. Treatment was completed without interruption in 24 patients, with a protocol implementation rate of 96%. The complete response rate was 100% in laryngeal cancer, and 80% in hypopharyngeal cancer, and total (including partial response) overall response rate was 100%. The laryngeal preservation rate was 96%, and the overall local control rate was 92%. All patients have been alive for at least 3 years without any recurrence.

Conclusions: The chemoradiation therapy using bi-weekly docetaxel is an extremely effective treatment for cancer of the larynx/hypopharynx, provided that it is used for the specified stage of cancer.

Key Words: larynx cancer • hypopharyngeal cancer • chemoradiation • docetaxel • laryngeal preservation


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