Survival data and toxicity profile in advanced non-small cell lung cancer (NSCLC) patients (PTS) treated within or outside controlled clinical trials.

Abstract

e18103 Background: Even without well defined data, a common perception is that clinical trials inclusion improve outcomes in pts with cancer. We conducted a retrospective analysis, in a single institution, evaluating survival data and tolerability in advanced NSCLC pts treated with standard therapy or within phase II/III clinical trials. Methods: We analysed 300 consecutive pts treated at the Thoracic Oncology Unit at San Luigi Gonzaga Hospital from 2004, January the 1st to 2011, December 31st having these characteristics: histo/cytological diagnosis of NCSLC, stage IV who received at least 3 chemotherapy cycles, minimum follow-up of 6 months. In this pts population 180 (60%) were enrolled in controlled clinical trials (T), while 120 (40%) were treated with standard therapy (S). Results: The most important differences between the two groups were about median age at the time of starting first line treatment (61.2 in group T vs 64 years in group S), pts older than 70 years (19% vs 27%, respectively) and ECOG/PS distribution (PS=2: 0 vs 9 pts, PS=1: 33 vs 53 pts, PS=0: 145 vs 60 pts in T and S group, respectively). Evaluating T and S population: 106 (59%) vs 43 (36%) pts were eligible for second line treatment and 45 (25%) vs 19 (16%) pts for third line treatment. Median OS was 16,3 in T population vs 14,4 months in S population and PFS was 7.1 vs 6.3 months respectively. Any relevant differences was seen between group T and S in terms of toxicity. Conclusions: This single institution retrospective analysis documented a trend of better outcome for pts enrolled in clinical trials compared to those treated with standard therapy (even without a statistical significance) with an higher percentage of pts reaching second and third line therapies. A larger multicenter prospective dedicated trial is needed to have further, more cleaned, data about this item.