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

• Published in: Japanese journal of clinical oncology Vol. 37; no. 9; pp. 641 - 646
• Main Authors: Yoshida, Tomoyuki, Tokashiki, Ryoji, Itoh, Hiroyuki, Nakamura, Kazuhiro, Hiramatsu, Hiroyuki, Tsukahara, Kiyoaki, Shimizu, Shigetaka, Takada, Daisuke, Okamoto, Isaku, Abe, Kimihiko, Suzuki, Mamoru
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.09.2007; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; chemoradiation; Chemotherapy, Adjuvant; Disease-Free Survival; docetaxel; Dose Fractionation; Drug Administration Schedule; Female; Humans; hypopharyngeal cancer; Hypopharyngeal Neoplasms - drug therapy; Hypopharyngeal Neoplasms - pathology; Hypopharyngeal Neoplasms - radiotherapy; Injections, Intravenous; Laryngeal Neoplasms - drug therapy; Laryngeal Neoplasms - pathology; Laryngeal Neoplasms - radiotherapy; laryngeal preservation; larynx cancer; Male; Maximum Tolerated Dose; Middle Aged; Neoplasm Staging; Radiation-Sensitizing Agents - administration & dosage; Radiation-Sensitizing Agents - adverse effects; Radiotherapy, Adjuvant; Taxoids - administration & dosage; Taxoids - adverse effects; Treatment Outcome; larynx cancer; laryngeal preservation; docetaxel; chemoradiation; hypopharyngeal cancer
• DOI: 10.1093/jjco/hym101
• ISSN: 0368-2811

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.