Abstract

e17503 Background: Pts with ES NSCLC are at significant risk for recurrence or SPTs. Identifying higher risk pts is key to personalizing therapy. Goals of the Vanguard trial are to assess smoking-related disease-free survival and to develop a risk model, utilizing a large cohort of archived ES NSCLC specimens, to predict the risk of recurrence or SPTs in this high risk group. Methods: Pts on the phase II prospective Vanguard study had definitively treated ES NSCLC or head and neck cancer and were current/former smokers. Pts had bronchoscopies with biopsies at 6 predefined sites at enrollment, 12, 24, and 36 months (mos). Serum was collected every 6 mos for 3 yrs. ES NSCLC pt specimens identified in our tumor bank were used to explore promising biomarkers; pathological and clinical data was collected for all pts. Results: 54 pts (46 eligible) were enrolled in the Vanguard trial between 12/04 and 2/09. Median age 61 yrs (42-81); 26 (57%) were male. 42 pts had NSCLC; stage I 32 (76%), II 8 (19%), IIIA 2 (5%). 9 pts (21%) have recurred and 3 pts (7%) have SPTs so far. 37 pts (80%) have completed bronchoscopy at 12 mo, 21 pts (46%) at 24 mos, 10 pts (22%) at 36 mos. 27 pts remain on study. Analyses are planned on biopsy specimens to characterize molecular changes in bronchial epithelium over time. Tumor specimens from 521 pts with ES NSCLC from 2002-2005 were also collected with outcome data. Tissue microarrays have been constructed from archived tumor specimens and numerous biomarkers were tested, including members of IGF, EGF, and apoptotic pathways. On multivariate analyses, several markers correlate with overall survival, including pAMPK (p=0.002), MCM6 (p=0.014), and CXCR2 (p=0.003). Conclusions: This is a unique pt cohort with prospectively collected bronchial specimens over a 3 yr follow-up period. Also, we have assembled a large matched population of over 500 archived ES NSCLC specimens. Molecular testing performed in archived specimens will be validated in the Vanguard pts, which will allow for analysis of progressive molecular changes in bronchial epithelium over time. With these results, we will establish a risk model for development of recurrence or SPTs in ES NSCLC pts. (DoD W81XWH-04-1-0142) No significant financial relationships to disclose.

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