An open multicenter phase II trial of weekly docetaxel for advanced-stage non-small-cell lung cancer in elderly patients with significant comorbidity and/or poor performance status: The GFPC 02-02b study

Summary: Context: The objective of this study was to evaluate the feasibility and activity of weekly docetaxel monotherapy in frail elderly patients with advanced-stage non-small-cell lung cancer, selected on the basis of their precise age, general condition, and number of comorbid disorders (Charlson score). Methods: Analysis of the response rate, toxicity, quality of life, median survival and 1-year survival rates after 1–3 six-week cycles of docetaxel 30mg/m2 weekly. Results: Fifty patients were enrolled and 42 were assessable. Five patients (10%, [3.7–22.6]) had objective responses, 14 (28%, [16.9–41.6]) had stable disease, and 23 (46%, [32.6–52.8]) progressed. The main grade 3–4 toxicity was fatigue (30%). Quality of life remained stable during treatment. The median survival time was 4.3 months, and the 1-year survival rate was 21.8%. Conclusion: In frail elderly patients selected on the basis of their age, general condition and comorbidity, weekly docetaxel monotherapy has acceptable toxicity and does not negatively affect quality of life. In contrast, it has only moderate activity. [Copyright &y& Elsevier]