Outcome of patients with advanced non-small-cell lung cancer and ECOG performance status 2: A retrospective analysis of the GOIM trials.

7152 Background: The better tolerability of new doublets due to progress in supportive care, anti-emetic prophylaxis, and better toxicity profile of newer cytotoxic drugs allowed investigators of the GOIM to include pts with PS 2 and low co-morbidity rate in prospective clinical trials.,In this paper we report a retrospective analysis of the clinical outcome and prognostic variables of pts with advanced NSCLC and PS 2 enrolled in clinical trials ran by the GOIM until 2003. A total of 1,108 pts were enrolled from 1993 until 2003 in three phase II and four phase III controlled clinical trials comprising a total of 203 pts with PS 2 (18.3% of the whole population). Pts were treated with CDDP 80-100mg/m2 plus VNR 25-30 mg/m2 d1+8, or GEM 1 gr/m2 d 1+8, the MVP or the IFO/VNR regimens.,ORR rate according to the WHO criteria was lower in the PS pts than in PS 0-1. Preliminary evaluation showed clinical improvement in cancer-related symptoms in 31% of pts. Median TTP of PS2 pts was 2.9 months (1-8 mos) with a 6-month progression-free probability rate of 16%. On the other hand, median TTP of patients with PS 0-1 was 5.7 mos (1-13.5 mos) with a 6-month progression-free probability rate of 43%. This difference in median TTP was highly significant (p = 0.008; HR 1.96). Median OS of pts with PS 2 was 5.5 mos with a 1-year survival rate of 13%, while that of pts with PS 0-1 was 9 mos with a 1-year survival rate of 30%. The difference in median survival was highly significant (p = 0.001; HR = 1.95). Analysis of prognostic factors showed no correlation between age and survival (r2 = 0.01; p = 0.08), and a statistically weak correlation between number of co-morbidities and survival (r2 =0.02; p = 0.044) in PS2 pts.,These data confirm the prognostic role of PS in pts with advanced NSCLC and support the urgent need of further trials to better define the role and type of treatment to give to NSCLC pts with PS2. No significant financial relationships to disclose.