First line chemotherapy with gemcitabine in advanced non-small cell lung cancer elderly patients: a randomized phase II study of 3-week versus 4-week schedule.

Purpose: This randomized phase II multicenter trial aimed at evaluating the efficacy and safety of the 4-week versus 3-week schedules of gemcitabine monotherapy in previously untreated elderly patients with advanced non-small cell lung cancer (NSCLC).

Patients And Methods: Chemonaive patients with stage IIIB or IV NSCLC, and age between 70 and 90 years, were randomized to receive gemcitabine dose of either 1000 mg/m2 on days 1, 8, 15, every 28 days (arm Q4W), or 1125 mg/m2 on days 1 and 8, every 21 days (arm Q3W).

Results: From June 1999 to January 2001, 81 patients (42 on arm Q4W; 39 on arm Q3W) were included.