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Prognostic and predictive value of HER2 extracellular domain in metastatic breast cancer treated with lapatinib and paclitaxel in a randomized phase III study
Journal of Clinical Oncology, 10/29/09

Finn RS et al. – The HER2 extracellular domain (ECD) is enzymatically cleaved from the cell membrane. Shed ECD in serum has been studied as both prognostic and predictive markers. Lapatinib is a dual inhibitor of HER2 and epidermal growth factor receptor kinases. We examined the prognostic and predictive role of HER2 ECD in a randomized trial of paclitaxel with placebo or lapatinib in women with HER2-negative or -unknown breast cancer. HER2 bECD does not predict lapatinib benefit in patients with HER2-negative MBC. Changes in ECD status correlates with patient outcome regardless of treatment given. Measuring HER2 ECD is not currently recommended for predicting benefit to lapatinib.

Methods

Patients (n = 579) with newly diagnosed metastatic breast cancer (MBC) randomly assigned to paclitaxel with placebo or lapatinib
HER2 status determined centrally
ECD centrally measured by enzyme linked immunoassay in available samples at baseline , week 9, and every 12 weeks thereafter
Results correlated to overall response rate (ORR) and PFS

Results

Elevated baseline ECD (bECD) levels ( 16 ng/mL) did not predict HER2 tumor status
In HER2-negative tumors, elevated bECD not correlated with improved efficacy for lapatinib plus paclitaxel versus placebo plus paclitaxel
ECD levels tended to decrease over time when bECD elevated
ECD conversion from low to high associated with worse PFS
Consistently low ECD level had better PFS than consistently elevated ECD
All associations found to be independent of lapatinib

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