A Randomized Phase II Trial of Two Schedules of Docetaxel in Elderly or Poor Performance Status Patients with Advanced Non-small Cell Lung Cancer

Background:We conducted a multicenter randomized phase II trial to evaluate two schedules of single-agent docetaxel in the first-line treatment of elderly and performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC).Methods:Patients 70 years of age and older with a PS 0–1 or patients of any age and PS 2 were randomly assigned to docetaxel 75 mg/m2 on day 1 every 3 weeks or 30 mg/m2 on days 1, 8, and 15 every 28 days. The primary end point was frequency of grade 3/4 toxicities. Health-related quality of life, response, and survival were secondary end points.Results:Fifty-five patients were randomized to received docetaxel every 3 weeks and 56 to receive docetaxel weekly. Hematologic toxicity, primarily grade 3/4 neutropenia, was significantly lower in the weekly schedule (0% versus 44%; p < 0.001). Health-related quality of life was similar between the two arms. Efficacy parameters were not significantly different, with a trend toward better survival in the weekly schedule group (6.7 versus 3.5 months). Patients with PS 0–1 had a significantly longer survival compared with PS 2 patients (7.8 versus 2.9 months; p < 0.001). A subset analysis of 30 octogenarian patients revealed similar outcomes as in 70- to 79-year-old patients.Conclusion:Weekly docetaxel is associated with less neutropenia and a trend toward improved survival in elderly or PS 2 patients. PS rather than age is the primary determinant of outcome in this population. Octogenarians benefited from weekly docetaxel. Future studies should separate elderly patients from PS 2 patients.