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Journal of Thoracic Oncology:
doi: 10.1097/01.JTO.0000284023.67406.be
Poster Abstracts: NSCLC: Cytotoxic Chemotherapy: NSCLC: Cytotoxic Chemotherapy Posters, Tue, Sept 4

Dose-Finding and Phase II Study of Weekly Docetaxel and Cisplatin as First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC): P2-315

Tsao, Thomas C.1; Hsia, Te-Chun2; Lin, Meng-Chih3; Hang, Liang-Wen4; Tsai, Ying-Huang5; Huang, Jen-Seng6; Wang, Jui-Long3

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1 Div. of Thoracic Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan 2 Hyperbaric Oxygen Therapy Center and Respiratory Intensive Care Units, China Medical University Hospital, Taichung, Taiwan 3 Div. of Chest Medicine, Dept. of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan 4 Respiratory Care Unit, China Medical University Hospital, Taichung, Taiwan 5 Div. of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan 6 Div. of Hemato-Oncology, Dept. of Internal Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan

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Objectives:

The aim of the present study is to evaluate the efficacy and toxicity of weekly docetaxel combined with cisplatin as first-line chemotherapy in patients with locally advanced or metastatic NSCLC and to identify the optimal dose of weekly docetaxel to be administered.

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Methods:

Chemonaive patients over 18 years of age with NSCLC stage IIIB and malignant pleural effusion, or stage IV were enrolled in this study. In the dose finding portion, patients received docetaxel once weekly at an initial dose of 25 mg/m2 for three weeks with cisplatin added on day 15 at a fixed dose of 75 mg/m2. The dose of docetaxel was escalated by 3 mg/m2 for each level to a maximum dose of 34 mg/m2. Treatment was repeated every 4 weeks for 6 cycles unless progressive disease, unacceptable toxicity, or consent withdrawal were present. Patients were enrolled in cohorts of 3 to receive combination chemotherapy. If a dose-limiting toxicity (DLT) occurred in 1 of the 3 patients, 3 additional patients would be enrolled at that dose level. DLT was defined as any grade 3-4 non-hematological toxicity (except alopecia, nausea and vomiting), grade 4 hematologic toxicity, or grade 3 hematologic toxicity with complications (e.g. neutropenic fever or bleeding). The maximum-tolerated dose (MTD) was defined as the dose immediately below the level associated with the occurrence of DLT in more than one-third of treated patients.

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Results:

Forty-nine patients were enrolled into this phase I/II study. In the dose-finding portion, the MTD of docetaxel was not reached since no patient developed DLT when docetaxel was given at the highest dose of 34 mg/m2. In the phase II portion, 18 patients received docetaxel at 34 mg/m2 and 14 patients received 31 mg/m2. Of the 49 eligible patients, none had a complete response and 19 achieved a partial response. The overall response rate was 38.8% (95% CI: 26.7-55.6%). Twenty-one patients (42.9%) had stable disease. The median survival was 13.1 months (95% CI: 10.4 - 15.6 months). Only 2 patients (4.1%) developed grade 3/4 neutropenia and there was no febrile neutropenia. The major non-hematological toxicities were asthenia and peripheral neuropathy, but most of them were grade 1 or 2.

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Conclusions:

Weekly docetaxel combined with cisplatin on day 15 has an acceptable toxicity profile and is an effective regimen as first-line chemotherapy in NSCLC. No dose-limiting toxicities were observed even when weekly docetaxel was given at 34 mg/m2.

Copyright © 2007 by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer.

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