VINORELBINE IS WELL TOLERATED AND ACTIVE IN THE TREATMENT OF ELDERLY PATIENTS WITH ADVANCED NONSMALL CELL LUNG-CANCER - A 2-STAGE PHASE-II STUDY

More than 30% of lung cancers arise in patients aged 70 years ok more; however, because elderly patients are not considered to tolerate chem otherapy, they are generally excluded from clinical trials and are not considered eligible. for aggressive cisplatin-based chemotherapy in c linical practice, The aims of the present study were to test: tolerabi lity and activity of weekly vinorelbine in advanced nonsmall cell lung cancer (NSCLC) patients aged 70 years or mere, and to define whether minimum conditions existed for a randomised comparison with best suppo rtive care. The study was designed as a multicentre two-stage phase II trial. according to Simon's optimal, design: 8 or more responses out of 43 treated patients were expected at the end of she trial. Patients aged 70 years or more were eligible if they had a cytological or hist ological diagnosis of NSCLC at stage IIIb-IV and a performance status less than or equal to two according to the ECOG scale. Vinorelbine was given intravenously (i.v.) at a dose of 30 mg/m(2) every week for 12 doses. As planned, 43 patients entered the study; median age was 73 ye ars (range 70-80); 11 patients were older than 75 years. Median dose-i ntensity (mg/m(2)/week) of vinorelbine was 21.2 (range 7.5-30) and was not affected by age of patients. Toxicity was generally mild, mainly haematological and never life-threatening. ECOG performance status imp roved in 26% of patients; cough and pain improved in more than 40% of patients symptomatic at entry, while dyspnoea improved in 28%; approxi mately half the patients had a stabilisation of their symptoms. 10 pat ients (23-95% exact confidence interval (CI): 12-39%) obtained a parti al response, Median time to progression was 11 weeks (95% CI 8-30) and median survival 36, weeks (35% CI 28-53). One-year estimated progress ion-free and overall survival rates are 16% and 36%, respectively. In conclusion, vinorelbine was well tolerated and active in the treatment of elderly NSCLC patients. A phase III trial (ELVIS-Elderly Lung Canc er Vinorelbine Italian Study) comparing best supportive care versus be st supportive care plus vinorelbine is now ongoing. (C) 1997 Elsevier Science Ltd.