A phase II study of vinorelbine in patients with advanced non-small cell lung cancer

Twenty-seven patients with non-small cell lung cancer were recruited into a phase II study of single-agent vinorelbine using a 25 mg/m(2) weekly dose schedule. All patients were inoperable (stage III disease - 11 patients; stage IV disease - 16 patients). Median age was 64 years (range: 37-72 years). Histological sub-types were squamous cell carcinoma (15 patients), adenocarcinoma (8) and large cell carcinoma (4). Partial response was documented in 4 (16%) of 25 evaluable patients, and stable disease in 13 (52%) patients. Median duration of response was 6.5 months (range 3-16 months) and median overall survival for patients with stable disease/partial response was 8 months (range 1-20 months). Vinorelbine was generally well tolerated although WHO grade 3/4 toxicity was noted for lethargy, constipation, alopecia (2 patients each), headache and non-tumour related bone pain (1 patient each). Vinorelbine is a moderately active single-agent in non-small cell lung cancer and is currently undergoing evaluation as part of combination chemotherapy regimens.