A PHASE-II STUDY OF VINORELBINE IN PATIENTS WITH ADVANCED NONSMALL CELL LUNG-CANCER

Twenty-seven patients with non-small cell lung cancer were recruited i nto a phase II study of single-agent vinorelbine using a 25 mg/m(2) we ekly 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 carcin oma (15 patients), adenocarcinoma (8) and large cell carcinoma (4). Pa rtial 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 patient s with stable disease/partial response was 8 months (range 1-20 months ). Vinorelbine was generally well tolerated although WHO grade 3/4 tox icity was noted for lethargy, constipation, alopecia (2 patients each) , headache and non-tumour related bone pain (1 patient each). Vinorelb ine is a moderately active single-agent in non-small cell lung cancer and is currently undergoing evaluation as part of combination chemothe rapy regimens.