Taxotere: Clinical Trials in Non‐Small Cell Lung Cancer

Abstract

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.