Japanese journal of clinical oncology · 2007
A phase I-II study of bi-weekly docetaxel combined with radiation therapy for patients with cancer of the larynx/hypopharynx.
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Yoshida Tomoyuki, Tokashiki Ryoji, Itoh Hiroyuki, Nakamura Kazuhiro, Hiramatsu Hiroyuki, Tsukahara Kiyoaki, Shimizu Shigetaka, Takada Daisuke, Okamoto Isaku, Abe Kimihiko, Suzuki Mamoru
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedAntineoplastic Agents, PhytogenicChemotherapy, AdjuvantDisease-Free SurvivalDocetaxelDose Fractionation, RadiationDrug Administration ScheduleFemaleHumansHypopharyngeal NeoplasmsInjections, IntravenousLaryngeal NeoplasmsMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingRadiation-Sensitizing AgentsRadiotherapy, AdjuvantTaxoidsTreatment Outcome