Docetaxel plus gemcitabine as front-line chemotherapy in elderly patients with lung adenocarcinomas: A multicenter phase II study

Background: The docetaxel/gemcitabine (DG) combination is an active and well-tolerated regimen against non-small cell lung cancer (NSCLC). A phase II study was conducted in order to evaluate its efficacy in elderly patients with lung adenocarcinomas. Methods: Chemotherapy-naive patients, aged >= 70 years, with locally advanced or metastatic lung adenocarcinomas and performance status (PS) <= 2 (ECOG) received gemcitabine 1100 mg/m(2) (days 1 + 8) and docetaxel 100 mg/m2 (day 8) with rhG-CSF support. Results: Seventy-seven patients were enrolled. One (1.3%) complete and 23 (29.9%) partial responses were achieved (intention to treat analysis: ORR 31.2%; 95% CI 20.82-41.51%) whereas tumor growth control was achieved in 53.3% of patients. The median TTP was 4.1 months, the median overall survival 9.4 month.; and the 1- and 2-year survival rate 37.9% and 10.7%, respectively. Grade 3-4 neutropenia occurred in 18.2% and febrile neutropenia in 3 (3.9%) patients. Non-haematological toxicity was mild with grade 2-3 asthenia occurring in 22.1% patients. Conclusions: The DG regimen is an active and well-tolerated front-line chemotherapy for elderly patients with lung adenocarcinomas and merits further evaluation in prospective randomized trials. (c) 2008 Elsevier Ireland Ltd. All rights reserved.