Docetaxel (D) plus gemcitabine (G) compared with G in elderly patients with advanced non-small cell lung cancer (NSCLC): Preliminary results of a randomized phase III Hellenic Oncology Research Group trial.

Abstract

7605 Background: To compare the docetaxel/gemcitabine (DG) combination versus gemcitabine (G) as first-line treatment of elderly patients with advanced non-small cell lung cancer (NSCLC). Methods: Chemotherapy-naïve patients >70y old with stage IIIB/IV NSCLC and performance status (PS) 0-2 were stratified according to stage and PS and randomized to either D 30 mg/m2 plus G 900mg/m2 (days 1 and 8) or G 1,200mg/m2 (days 1 and 8) every 21 days. A comprehensive geriatric assessment (CGA) was also performed. Results: From 3/2006 to 12/2009, 94 patients (DG n=49; G n=45) were enrolled onto the study. Median age was 74 (range, 70 to 84) and 78 years (range, 70 to 92) in the DG and D arm respectively (p<0.001). Sixty-five (69%) patients had stage IV disease and 16 (17%) a PS of 2. With a median follow-up of 10.27 months, there was no difference in terms of median OS (15.9 vs. 12.2 months; p=0.072), median TTP (3.17 vs. 2.53 months; p=0.227) and ORR (28.3% vs. 11.6%; p=0.066). Patients with an Instrumental Activities of Daily Living (IADL) score <7 had a significantly lower median OS (10.13 vs. 17.3 months; p=0.025) and median TTP (2.13 vs. 4.7 months; p=0.023) than patients with an IALD score of 7-8. The most common toxicity was grade 3/4 neutropenia (8.1% and 6.6% for DG and G, respectively; p=0.545). Conclusions: The DG regimen did not improve OS and TTP in elderly patients with NSCLC; however, patients with high IADL score have a significantly better clinical outcome than patients with low IADL score. No significant financial relationships to disclose.