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Clinical Research 11: Molecular Markers in Diagnosis and Prognosis 2: Breast Cancer |
Lebanon VA Medical Center, Lebanon, PA, Penn State University/Hershey Medical Center, Hershey, PA, Oncogene Science/Bayer Diagnostics, Cambridge, MA, Novartis Pharma AG, Basel, Switzerland
Background: The epidermal growth factor receptor (EGFR, erbB1) has been reported to be overexpressed in breast cancer, and in some reports is a significant prognostic factor based on immunohistochemistry of the primary tumor. We previously reported that 71/265 metastatic breast cancer patients (26.8 %) had a decreased pretreatment serum EGFR level and decreased response and survival in a phase III second-line hormone therapy trial (Proc. ASCO 21:436a, Abstract 1743, 2002). Methods: The Oncogene Science/Bayer Diagnostics EGFR ELISA was used to quantify serial serum EGFR from 71 metastatic breast cancer patients who had decreased pretreatment serum EGFR associated with decreased response and survival to hormone therapy. These patients were selected from 265 post-menopausal metastatic breast cancer patients enrolled in a multicenter, randomized, double-blind, phase III second-line hormone therapy trial (fadrozole vs. megestrol acetate). The pretreatment and 1 month post-treatment serial serum EGFR profiles were correlated with subsequent patient response and survival to second-line hormone therapy. Serum EGFR from a control group of 59 healthy females was also measured. Results: In the healthy control group, mean serum EGFR was significantly higher in post-menopausal females (89.87±16.40 ng/mL, n=13) compared to pre-menopausal females (79.54±9.87 ng/mL, n=46) (p=0.006). Using a cutpoint of 57.07 ng/mL (mean - 2SD) derived from the post-menopausal female control group, 71/265 patients (26.8%) had a decreased pretreatment serum EGFR level, compared to 0/13 controls. Serial serum samples were available from 57 of the 71 patients with decreased pretreatment serum EGFR. When defining a serial serum EGFR change of greater than 20% difference from the pretreatment serum EGFR level as a significant change, 29/57 patients (50.9%) had an increasing serum EGFR level at 1 month post treatment, whereas 28 patients (49.1%) had either a decreasing (6 patients) or unchanged serial EGFR level (22 patients). When comparing the decreasing or unchanged serial serum EGFR patient group with the increasing serial EGFR patient group, there was no significant difference in objective response rate (ORR, p= .70), clinical benefit rate (CBR, p= .70), and time to progression (TTP, p= .46) to second-line hormone therapy. However, there was a trend for shorter overall survival in the patient group who had decreasing or unchanged serial serum EGFR (p=.058)(median survival 15.6 mo. vs. 28.1 mo.).Conclusions: Metastatic breast cancer patients with decreasing or unchanged serial serum EGFR profile after second-line hormone therapy have a shorter overall survival. Monitoring serum EGFR level may have potential for evaluation and/or selection of patients for anti-EGFR-directed therapies.
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