Paclitaxel plus gemcitabine in advanced non-small cell lung cancer patients with low performance status

Background: The aim was to determine the efficacy and safety of a platinum-free regimen combining gemcitabine and paclitaxel for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and a low performance status (PS). Patients and Methods: Patients with histologically confirmed unresectable NSCLC, no previous chemotherapy, measurable lesion and a PS of 2 or 3 according to the Eastern Cooperative Oncology Group (ECOG) scale were elegible. Chemotherapy consisted of paclitaxel 200 mg/m(2) on day 1 plus gemcitabine 1000 mg/m(2) on days 1 and 8, every 3 weeks, for a maximum of 8 cycles. Results: Twenty-nine consecutive patients were enrolled. PS was 2 and 3 in 93% and 7% of patients, respectively. A total of 149 courses of chemotherapy were delivered (median 4.6). Responses: complete response 1 (3.4%), partial response 11 (37.9%), stable disease 12 (47.3%), progressive disease 5 (17.2%) (response rate 41.3%, 95% CI: 23.5% to 61.6%). Median time to progression was 8.3 months (range 2.9-31.7); median overall survival was 13.6 months (range 3.2-37.7). Grade 3 leukopenia occurred in 3% of patients, while grade 3 thrombocytopenia was observed in 25% of patients. Conclusion: Reasonable response rates and a satisfactory clinical benefit can be obtained with a platinum-free regimen in NSCLC patients with a low PS.