Retrospective comparison of toxicity and efficacy in phase II trials of 3-h infusions of paclitaxel for patients 70 years of age or older and patients under 70 years of age

Purpose: To evaluate the safety and efficacy of paclitaxel in elderly patients with advanced non-small-cell lung cancer (NSCLC). Methods: We compared the toxicity, response, survival and pharmacokinetic parameters between patients between 70 and 75 years of age (elderly group) and those under 70 years of age (younger group) who were enrolled in two phase II trials of 3-h infusions of paclitaxel. Results: A total of 120 patients were eligible for the studies, of whom 28 were in the elderly group and 92 in the younger group. Neutropenia was the most prominent toxicity. Grade 3-4 neutropenia was recorded in 89.3% of the elderly group and in 73.9% of the younger group (P = 0.13). Other hematological and non-hematological toxicities were mild regardless of age. Tumor response (46.4% vs 32.2%) and median survival time (9.8 months vs 6.8 months) did not differ between the elderly and younger groups. Pharmacokinetic studies failed to detect any difference between the two groups. Conclusion: Intravenous 3-h infusions of paclitaxel are as safe and effective in elderly patients with NSCLC as in younger patients.