Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303

• Median OS/PFS (95% CI) estimated from Kaplan-Meier curves for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
  
• Stratified OS/PFS hazard ratio (HR) (95% CI) from the Cox model for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
  
• Stratified OS/PFS HR (95% CI) from Cox model by quartile of VEGF-A levels [ Designated as safety issue: No ]
  

• Number and percentage of responders and the stratified objective response (OR) from logistic regression for patients with high and low concentration of biomarker [ Designated as safety issue: No ]
  

OBJECTIVES:

• To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the same Immunological Multiparameter Chip Technology (IMPACT) assay.
• To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for progression-free survival (PFS), and other circulating biomarkers in study BO17706, can be replicated in study CALGB-80303 using the same IMPACT assay.
• To explore the relationship between efficacy and other biomarkers measured in the plasma samples.

OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.

The following markers are analyzed in EDTA plasma samples using the Immunological MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.