Abstract

e19016 Background: Approximately 40% of NSCLC pts present with metastatic disease where treatment is considered palliative. Here we examine whether prolonged survival is possible in a sizeable proportion of NSCLC pts with good PS and stage IV disease particularly given the availability of personalized chemotherapy approaches. Methods: NSCLC pts with stage IV disease and an ECOG PS of 0/1 were prospectively accrued to four phase II clinical trials, at the H. Lee Moffitt Cancer Center and treated with the following regimens; Trial A) carboplatin/gemcitabine first-line followed by docetaxel second-line, Trial B) docetaxel and gefitinib combination therapy in patients aged 70 years or older, Trial C) combination therapy with carboplatin/paclitaxel/atrasentan, Trial D) personalized therapy (PT) based on ERCC1 and RRM1. Pts with low RRM1/low ERCC1 received gemcitabine/carboplatin; low RRM1/high ERCC1, gemcitabine/docetaxel; high RRM1/low ERCC, docetaxel/carboplatin; high RRM1/high ERCC1, vinorelbine/docetaxel. Data were updated as of 10/23/08. Overall survival was estimated using the piecewise exponential survival function which showed a dramatic shift at 29 months. Results: A total number of 181 pts were accrued. The median survival for the entire cohort was 10.5 months improving dramatically to 85.3 months, if alive at 29 months (adjusted P = 0.005). In the entire cohort, 16.7% of pts survived to 29 months compared to 25% of pts in the PT group. For pts who were alive at 29 months, the probabilities of surviving to 48, 60, 72 and 84 months were 79%, 68%, 59% and 51%, respectively. Conclusions: Long term survival is possible in a sizeable proportion of stage IV NSCLC with good PS. Our treatment paradigm should shift from palliation to achieving long term survival. Molecularly-based PT may be one way of achieving this goal. No significant financial relationships to disclose.

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