1. J Thorac Oncol. 2012;7: 1653–1660) David P. Carbone, MD, PhD,* Keyue Ding, PhD,† Heinrich Roder, PhD,‡ Julia Grigorieva, PhD,‡ Joanna Roder, PhD,‡ Ming-Sound Tsao, MD, PhD,§ Lesley Seymour, MD, PhD,† and Frances A. Shepherd, MD Journal conference R2 Seon-Hye Kim, Prof. Jae-Heon Jeong

2. Erlotinib (1 st line TKI, Tarceva) :The overall response rate was 8.9% in the erlotinib arm compared with less than 1% for placebo, and both progression-free survival (PFS) and overall survival (OS) were prolonged by erlotinib. EGFR mutation : EGFR mutations were prognostic for OS, but were not predictive, whereas increased EGFR copy number was both prognostic and predictive for OS benefit.

3. Tumor tissue was not available in all patients, highlighting the need for less-invasive predictive tests such as serum or plasma biomarkers. VeriStrat : a commercially available serum- or plasma-based test using MALDI mass spectrometry methods. : was developed using a training set of pretreatment serum samples from patients who experienced long-term stable disease or early progression on gefitinib therapy : binary classification - Good or Poor

4. Primary Goal : investigated the predictive and prognostic effects of VeriStrat on response and survival in a subset of patients enrolled on the NCIC Clinical Trials Group, BR.21 phase III trial of erlotinib versus placebo in previously treated advanced NSCLC patients.

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13. Biomarker-based selection of patients for specific targeted therapies is becoming a standard of care. EGFR mutations & high EGFR copy number are predictive of response to erlotinib, but mutation status was not predictive of OS benefit compared with pts with wild-type EGFR tumors. Sample tissue collection and successful mutation analysis typically have been low (20%–30%), so non-invasive tests in every patient to obtain sample can be useful biomarkers.

14. VeriStrat (blood-based test) : reproducible, readily available, and has the potential to overcome the difficulties of obtaining fresh biopsy tissue. Our results confirm a predictive effect of VeriStrat for response, not confirm a predictive effect for VeriStrat on OS or PFS.

15. VeriStrat is able to predict response to erlotinib and is a prognostic biomarker in previously treated pts with advanced NSCLC. Further studies are required to define the clinical utility of VeriStrat and other blood-based biomarkers in defining the appropriate patient population for therapy with erlotinib and other EGFR-based therapeutics.