A phase II study with gemcitabine and split-dose cisplatin in patients with advanced non-small cell lung cancer

Background: The combination of gemcitabine and cisplatin is among the most active regimens for the treatment of NSCLC. However, the optimal dose and schedule for administration of the two drugs has not yet been determined. We investigated the activity and toxicity of a gemcitabine and split-dose cisplatin regimen in an outpatient setting for patients with advanced non-small cell lung cancer (NSCLC). Patients and methods: From June 2004 to May 2005 patients with stage IIIB or IV who had not had prior chemotherapy entered the study. Treatment consisted of gemcitabine 1250mg/m² and cisplatin 35mg/m², both given intravenously on days 1 and 8 every 21 days. Results: Forty-five patients were entered this study. Patient characteristics were as follows: male/female, 34/11; median age (range), 62 (30-76) years; ECOG PS 0/1/2, 7/30/8; stage IIIB/IV, 18/27. A total of 168 cycles were delivered, with a median of 4 cycles (range, 1-6). All patients were evaluable for toxicity. Grade 3 and 4 toxicities according to the NCI toxicity criteria included neutropenia in 8 patients (18%), anemia in 4 (9%), thrombocytopenia in 7 (15%), and emesis in 1 (2%). Of 42 patients assessable for response, 23 patients showed a partial remission. On intent-to-treat basis, the overall response rate was 51% (95% CI, 37-65%). Median time to progression was 6.0 months (range, 1.2-12.0 months) and median overall survival was 13.1 months (range, 1.4-17 months). Conclusions: This regimen with gemcitabine and split-dose cisplatin using a 21-day schedule appears to be active and very well-tolerated in an outpatients setting for patients with advanced NSCLC.