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Meta-analysis of the predictive and prognostic value of erlotinib-related biomarkers in phase III, placebo-controlled trials in non-small cell lung cancer (NSCLC): Recommendations of the BioLOGUE advisors.

7533 Background: The BioLOGUE (Biomarkers Lung Oncology Group Understanding Erlotinib) advisors carried out a meta-analysis using two phase III, placebo-controlled trials of erlotinib to determine the clinical utility of four tumor-based biomarkers (BMs) in the post-first line setting: EGFR protein expression (immunohistochemistry [IHC]); EGFR copy number (fluorescent in-situ hybridization [FISH]); EGFR activating mutations; and KRAS mutations.


METHODS
Patient-based data from BR.21 and SATURN were pooled to carry out univariate and multivariate analyses of PFS and OS, with or without clinical factors, which differentiated between predictive and prognostic effects. Stepwise variable selection was used to identify any confounding relationships between BMs, clinical factors and outcome. Full methodology will be presented.


RESULTS
Results of the pooled meta-analysis for each BM are shown in the table: X indicates a predictive effect for outcome with erlotinib, Y+ and Y- indicate a positive or negative prognostic effect, respectively, and x or y indicate a trend, i.e. 0.05 < p ≤0.10.


CONCLUSIONS
Based on these analyses, EGFR IHC, EGFR FISH and KRAS mutations should not be used to positively or negatively select patients for erlotinib after first-line chemotherapy. EGFR mutation testing, while of value in the first-line setting, should not be used to positively or negatively select patients for maintenance/second-line erlotinib. [Table: see text].