Randomized phase II study of two gemcitabine schedules for patients with impaired performance status (Karnofsky performance status ≤ 70) and advanced non-small-cell lung cancer

Purpose: This randomized phase II study compared two treatment schedules of gemcitabine in patients with non-small-cell lung cancer (NSCLC) and impaired Karnofsky performance status (KP). Primary objectives were to record changes from baseline KP and to assess symptom palliation. Secondary objectives were overall survival, tumor response, and toxicity. Patients and Methods: Patients with stage IIIb and IV NSCLC and KP ≤ 70 were randomly assigned to receive gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of each 28-day cycle (3w4) or gemcitabine 1,500 mg/m2 on days 1 and 8 of each 21-day cycle (2w3), both for up to six cycles. KP, toxicity, and SS14 lung cancer specific questions were recorded before each cycle of treatment. Response was evaluated 4 weeks after the last cycle. Results: One hundred seventy-four patients were enrolled. There was significant early attrition due to disease progression; only 61.5% of patients were alive at 2 months. There was a significant improvement in KP from baseline to pre-cycle 3 in both arms, with a trend in favor of the 3w4 regimen for duration and faster onset of improvement. Eight of the 17 quality-of-life (QOL) variables assessed showed an improvement of more than 10% between baseline and the start of the third cycle of treatment. Response rate, survival, and duration were similar in both arms. Conclusion: There was no significant difference between the two schedules examined in terms of improvement in KP or QOL, but there seemed to be a trend in favor of the 3w4 schedule. © 2005 by American Society of Clinical Oncology.