Elderly patients with advanced non-small cell lung cancer - A phase II study with weekly cisplatin and gemcitabine

Objectives: The incidence of non- small cell lung cancer ( NSCLC) is increasing among the elderly. We studied the toxicity and efficacy of a weekly schedule of gemcitabine and cisplatin in elderly patients with advanced NSCLC. Methods: Patients aged 70 years or above with advanced NSCLC were treated in a phase II prospective trial with gemcitabine 1,000 mg/m(2) and cisplatin 35 mg/m(2) on days 1, 8 and 15 every 28 days. Results: Forty- eight patients with a median age of 74 years ( range 70 - 78) participated in the study. We observed 14 cases with partial response, 14 with stable disease and 16 with progressive disease, whilst 4 patients were not evaluable. By intention-to- treat analysis, partial response rate was 31.8% whilst progressive disease was 33.3%. Median survival was 9 months; 1- year survival probability was 34.4% and median time to progression was 4 months. Grade III - IV leukopenia was observed in 5/ 48 patients ( 10.4%), 20/ 48 patients ( 41.7%) had grade III - IV thrombocytopenia and 7/ 48 patients ( 14.6%) had grade III - IV anemia. One patient experienced grade III emesis and 2 patients had grade III - IV fatigue. Conclusions: At this dose and schedule the combination of gemcitabine and cisplatin appears to be an active and well- tolerated regimen for elderly patients with advanced NSCLC. Copyright (C) 2003 S. Karger AG, Basel.