A phase II study of weekly paclitaxel in elderly patients with advanced non-small cell lung cancer.

Abstract

PURPOSE:

Our aim was to evaluate the efficacy, toxicity, and pharmacokinetic behavior of single-agent paclitaxel given weekly to elderly patients with lung cancer.

EXPERIMENTAL DESIGN:

Previously untreated patients with stage IIIB/IV non-small cell lung cancer were eligible for the study if they were at least 70 years of age and had preserved organ function. Paclitaxel was administered over 1 h at a dose of 90 mg/m(2) for 6 consecutive weeks on an 8-week cycle. The pharmacokinetics of paclitaxel were assessed during the first and sixth week of therapy in a subgroup of eight patients.

RESULTS:

A total of 35 patients (median age, 76 years; range, 70-85) were enrolled. The overall response rate was 23%. Median time to failure was 5.2 months, whereas the median survival time was 10.3 months. Survival rates after 1 and 2 years were 45 and 22%, respectively. Grade 3/4 toxicities included neutropenia (5.8%), hyperglycemia (17.6%), neuropathy (5.8%), and infection (8.8%). Two patients died from treatment-related toxicity. There was no significant difference (P = 0.18) between the total body clearance of paclitaxel on the first (17.4 +/- 2.9 liters/h/m(2), mean +/- SD) and sixth (15.8 +/- 4.1 liters/h/m(2)) week of therapy.

CONCLUSION:

Paclitaxel administered as a weekly 1-h infusion at a dose of 90 mg/m(2) is a safe and effective therapy for elderly patients with advanced non-small cell lung cancer. Its pharmacokinetics in elderly patients do not appear to differ from historical data for younger patients, and there was no suggestion of a change in drug clearance after repeated weekly dosing.

• Authors: P Fidias, J G Supko, R Martins, A Boral, R Carey, M Grossbard, G Shapiro, P Ostler, J Lucca, B E Johnson, A Skarin, T J Lynch
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 7 Issue 12 Pg. 3942-9 (Dec 2001) ISSN: 1078-0432 [Print] United States
• PMID: 11751486 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Paclitaxel

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (adverse effects, pharmacokinetics, therapeutic use)
• Area Under Curve
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Humans
• Infusions, Intravenous
• Lung Neoplasms (drug therapy, mortality, pathology)
• Metabolic Clearance Rate
• Neoplasm Staging
• Paclitaxel (adverse effects, pharmacokinetics, therapeutic use)
• Survival Rate
• Time Factors