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A phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer
Clinical Cancer Research, 12/08/08

Dickler MN et al. - In a study to evaluate efficacy and toxicity of erlotinib plus bevacizumab in pts with metastatic breast cancer (MBC), targeting epidermal growth factor receptor (EGFR/HER1) and vascular endothelial growth factor (VEGF) pathway, it was found that the combination of erlotinib and bevacizumab was well-tolerated but had limited activity in unselected pts with previously treated MBC. Biomarkers are needed to identify those MBC pts likely to respond to anti-EGFR/HER1 plus anti-VEGF therapy.

Methods

38 pts with MBC were enrolled and treated with erlotinib (150 mg p.o. daily) plus bevacizumab (15 mg/kg i.v. every 3 wks).
Pts had 1 to 2 prior chemotherapy regimens for metastatic disease.
Primary endpoint was response rate by Response Evaluation Criteria in Solid Tumors criteria using a Simon 2-stage design.
Secondary endpoints included toxicity, time to progression, response duration, and stabilization of disease of 26 wks.
Correlative studies were done on tumor tissue, including EGFR expression and mutation analysis.

Results

1 pt achieved a partial response for 52+ mos.
15 pts had stable disease at first evaluation at 9 wks; 4 of these pts had stable disease beyond 26 wks.
Median time to progression was 11 wks.
Diarrhea of any grade was observed in 84% of pts; 76% experienced grade 1 or 2 skin rash, and 18% developed hypertension.
Level of EGFR expression was not predictive of response to therapy.

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