Molecular Correlates of Response to C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck (E3303): A Phase II Trial of Eastern Cooperative Oncology Group
- To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303,
including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
- To correlate the status or expression level of each biomarker with clinical outcome
(response, progression-free survival, overall survival).
OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16
status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and
activation of several signaling pathways including PI3 kinase gene and mTOR; levels of
ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha
(TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand,
and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ
quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.
Correlation of biomarkers and clinical outcome
Jennifer R. Grandis, MD
University of Pittsburgh