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Taxotere: Clinical Trials in Non-Small Cell Lung Cancer

Thoracic Oncology Program, Norris Cotton Cancer Center, Section of Hematology/Oncology; Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA; Dartmouth Medical School, Hanover, New Hampshire, USA

Correspondence: James R. Rigas, M.D., Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, New Hampshire, 03756-0001 USA. Telephone: 603-650-6344; Fax: 603-650-8287; e-mail: james.r.rigas{at}dartmouth.edu

Cisplatin-based chemotherapy regimens of the 1980s have shown a small but significant impact on survival for patients with advanced non-small cell lung cancer (NSCLC). New agents, including docetaxel, have shown encouraging single-agent activity in this disease. This potent microtubule stabilizing agent was selected for clinical development based on its preclinical superiority to paclitaxel. Three hundred twenty-eight (328) patients with advanced or recurrent NSCLC have been enrolled in seven phase II trials of 100 mg/m² of docetaxel administered intravenously every 21 days. Four of the trials enrolled 160 chemotherapy-naive patients, and three of the trials enrolled 168 patients who failed prior platinum-containing chemotherapy. The antitumor response rate for 160 chemotherapy-naive patients was 27% (95% confidence interval: 20%-34%) with a median survival time of 9.2 months and for 168 platinum-treated patients, 17% (95% confidence interval: 11%-23%). Alopecia, fluid retention, infusion-related reactions, leukopenia, onycholysis, and rash were adverse events observed in these trials. Dexamethasone premedication lessens the frequency and severity of fluid retention, infusion-related reactions, and rash. Docetaxel demonstrates significant antitumor activity in chemotherapy-naive and platinum-treated patients with NSCLC. Trials of docetaxel in combination with carboplatin, cisplatin, vinorelbine, gemcitabine, irinotecan, and thoracic radiation and as primary chemotherapy for stage III NSCLC are in progress.

Key Words. Non-small cell lung cancer • Docetaxel • Phase II trials