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HER-2 gene amplification, HER-2 and epidermal growth factor receptor mRNA and protein expression, and lapatinib efficacy in women with metastatic breast cancer
Clinical Cancer Research, 12/08/08

Press MF et al. - Women with HER-2-positive metastatic breast cancer (BCa) benefit from lapatinib, whereas women with HER-2-negative metastatic BCa derive no incremental benefit from this treatment.

Methods

Aim was to analyze the biomarkers from two randomized phase III trials to optimize selection of pts for lapatinib therapy
Breast cancer tissue from EGF30001 and EGF100151 trials analyzed for:
HER-2 gene amplification by FISH
HER-2 mRNA by RT-PCR
HER-2 protein expression by HercepTest IHC
EGFR mRNA level by RT-PCR, and EGFR protein by IHC
All compared with clinical outcomes

Results

HER-2 gene amplified in 47% and IHC was 3+ in 35%
Positive EGFR immunostaining in 28% correlated with EGFR mRNA levels by RT-PCR
HER-2 gene amplification/overexpression associated with improved clinical outcomes in both trials
An improvement in outcome was seen in FISH-positive and IHC 0, 1+, or 2+ pts
HER-2 mRNA expression correlated with HER-2 FISH and IHC status
No correlation between EGFR expression and responsiveness to lapatinib regardless of HER-2 status