Abstract
e20515 Background: It is known that outcome of patients included in clinical trials have a better outcome than patients treated with standard therapy. This is a retrospective case-control study of outcome of patients with stage III and IV non-small cell lung cáncer (NSCLC) recruited in clinical trials vs advanced NSCLC patients in usual clinical practice in our institution. Methods: We performed a case-control study matching all patients participating in trials with chemotherapy and/or TKis (immunotherapy was not included) in a 5 year period (January 2010-November 2014) in 1st line setting, matching them in a ratio 1:2 with individuals in usual clinical practice. There were 36 patients in trials and 72 patients treated by our protocol. Cases were matched by age ( < 65 and > 65), histology (adenocarcinoma and squamous), EGFR status (mutated and wild-type). All patients were WHO performance status 0-1. Results: Patients in each group were matched for stage, histological subtype, previous surgery and systemic therapy. Median follow up for patients treated on a trial was 3.3 years, compared with 2.9 years for matched patients who received standard 1st line therapy. Median overall survival for patients included a trial was 19.6 months, and 15.7 months for control group. The difference between groups was not significant (Log rank test, HR 0.81, 95% CI: 0.42 to 1.30, p = 0.53). Median overall survival in younger patients in trials ( < 65) was 19.3 months, and in elderly patients was 19.8 months. The median progression-free survival in the two groups was 6.8 and 5.5 months respectively (HR 0.72, 95% CI 0.30 to 1.43, p = 0.21). Conclusions: In our institution, we didn’t found significant differences for overall survival or progression-free survival, but there is a trend for a better outcome for those items. Benefit seems to be similar in younger patients than in older patients, so this encourages recruiting of selected elderly patients.
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