A phase II study of non-platinum based chemotherapy with paclitaxel and vinorelbine in non-small cell lung cancer

Introduction: Paclitaxel and vinorelbine combination in previous untreated patients with stage IIIb-IV non-small cell lung cancer (NSCLC) as a phase II study. Patients and methods: Thirty-four patients (4 patients with stage IIIb, 30 patients in stage IV), with median age 66 and performance status 0.1. were administered paclitaxel, 175 mg/m(2) in a 3-h infusion rate on day, I and vinorelbine, 25 mg/m2 in a 10-min infusion rate on days 1, and 8 with G-CSF and EPO support. Results: Among our 33 evaluable patients for toxicity 16 patients (48.4%) presented leukopenia, and 15 patients (45.4%) presented anemia despite G-CSF and EPO administration. Two patients (6%) presented Grade III-IV peripheral neuropathy. The overall response rate was 67.7%; 5 patients (16.1%) showed complete response (2 patients stage IIIb) and 16 patients (51.6%) showed partial response (I patient stage IIIb). The overall median survival time was 10 months (range 3-18 months) and the median disease-free survival was 9 months (range 3-15 months) with an 1-year survival time of 45.1 (14 patients). Conclusion: The results of the combination as 1st line treatment for patients with nonoperable NSCLC are promising and should be further investigated. (C) 2002 Published by Elsevier Science Ireland Ltd.