P2-282: Gemcitabine and vinorelbine combination as second-line therapy in previously taxane and platinum-treated non-small cell lung cancer

Gemcitabine (G) and vinorelbine (V) combination showed tolerable toxicities with response rate of 10-30% as second-line chemotherapy at several phase II studies. We evaluated its efficacy and toxicity in previously taxane and platinum-treated refractory NSCLC. From July 2004 to February 2007, 25 evaluable patients were enrolled. All patients were refractory or resistant NSCLC after taxane and platinum combination as first-line therapy for advanced NSCLC and ECOG PS 0-2. Treatment consisted of gemcitabine 1000 mg/m2 plus vinorelbine 25 mg/m2 i.v. on days 1 & 8 of a 21-day cycle. Among a total of 25 patients, 23 patients were evaluable for response and all 25 patients for toxicity. Median age was 58 years (range 44-79) and gender ratio was 19 males/6 females. Objective responses were seen in 5 of 23 evaluable patients (22%). four patients (18%) had stable disease and 14 patients (60%) progressive disease. Median overall survival was 5.3 months. A median of 2 cycles per patients were administered (range 1-8). The median delivered dose was 538.5 mg/m2/week of gemcitabine and 13.3 mg/m2/week of vinorelbine and relative dose intensity was 81% and 80%, respectively. Grade 3/4 neutropenia occurred in 68% but, febrile neutropenia only occurred in 12%. Nausea, vomiting, anorexia, neuropathy and liver dysfunction were mild in most of patients. Grade 3 asthenia occurred in 20%. There was no predictive factor for tumor response of second-line therapy. For univariate analysis for overall survival, the responder of first-line, good performance status, and disease-stabilized patients of GV chemotherapy were significantly analyzed (p<0.05). Gemcitabine and vinorelbine combination therapy showed modest efficacy with disease stability of 40% and tolerable toxicity profile in patients with previously taxane and platinum-treated refractory NSCLC.