Phase II trial of gemcitabine and vinorelbine in patients with stage III B and IV non small cell lung cancer

Background. Gemcitabine and vinorelbine are active agents in advanced non-small cell lung cancer. We conducted a phase II trial of this combination in untreated patients with stage III B or IV non-small cell lung cancer.Patients and methods. Treatment was administered on days 1, 8 and 15 of a 28-day cycle with vinorelbine at a dose of 17.5 mg/m2 and gemcitabine 1,000 mg/m2. Patient characteristics included: 25 patients (18 males), median age 63.5 years (range: 44–74). PS ≤ 2 in all patients. All patients were included in the survival and toxicity analysis, one patient was not evaluated for response.Results. Five patients achieved a partial response, 14 patients had disease stabilization and five patients had progressive disease. Median survival for the group was 29 weeks (range: 4–95).Grade 3 and 4 toxicities included thrombocytopenia in 11 patients, neutropenia in 4 patients. Four patients died of thromboembolic events including cerebrovascular accidents and myocardial infarctions. Three patients experienced venous thromboses and 1 arterial thrombosis requiring intervention.Conclusion. This data suggests that this non cisplatinum-containing regimen is as efficacious as other platinum combinations with a different toxicity profile.