A phase I-II study of bi-weekly docetaxel combined with radiation therapy for patients with cancer of the larynx/hypopharynx.

Abstract

BACKGROUND:

We performed a phase I/II study 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.

• Authors: Tomoyuki Yoshida, Ryoji Tokashiki, Hiroyuki Itoh, Kazuhiro Nakamura, Hiroyuki Hiramatsu, Kiyoaki Tsukahara, Shigetaka Shimizu, Daisuke Takada, Isaku Okamoto, Kimihiko Abe, Mamoru Suzuki
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 37 Issue 9 Pg. 641-6 (Sep 2007) ISSN: 1465-3621 [Electronic] England
• PMID: 17940076 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents, Phytogenic
• Radiation-Sensitizing Agents
• Taxoids
• Docetaxel

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
• Chemotherapy, Adjuvant
• Disease-Free Survival
• Docetaxel
• Dose Fractionation, Radiation
• Drug Administration Schedule
• Female
• Humans
• Hypopharyngeal Neoplasms (drug therapy, pathology, radiotherapy)
• Injections, Intravenous
• Laryngeal Neoplasms (drug therapy, pathology, radiotherapy)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Radiation-Sensitizing Agents (administration & dosage, adverse effects)
• Radiotherapy, Adjuvant
• Taxoids (administration & dosage, adverse effects)
• Treatment Outcome