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Old 01-20-2006, 09:05 AM   #1
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Post Combo of Gefitinib w/ weekly Epirubicin

(c) Copyright 2006 Women's Health Weekly via NewsRx.com

2006 JAN 26 - (NewsRx.com) -- Gefitinib with weekly epirubicin controls
disease in patients with metastatic breast cancer.

"Epidermal growth factor receptor (EGFR) is overexpressed in
approximately 50% of invasive breast carcinomas and it is correlated
with hormone resistance and poor prognosis. EGFR suppression by
gefitinib, a quinazoline derivative that inhibits phosphorylation of the
specific receptor, represents a novel therapeutic strategy," scientists
in Italy report.

"A dose-finding study was performed to evaluate the combination of
gefitinib with weekly epirubicin in patients with pretreated metastatic
breast cancer. Fifteen patients were enrolled at four sequential dose
levels. Gefitinib was administered orally, at the fixed daily dose of
250 mg. The starting dose of epirubicin was 20 mg/m2," said G. Gasparini
and colleagues, San Filippo Neri Hospital.

"Escalating dose levels of epirubicin were planned by increments of 5
mg/m2 per level, up to the maximum tolerated dose (MTD). Pharmacodynamic
studies were performed by determining serum and tissue ERBB2 and EGFR.
At the first three dose levels tested no patient experienced a
dose-limiting toxicity (DLT)."

Research showed that "in cohort 4, 2 patients experienced DLTs (grade 4
dyspnea and asthenia, grade 3 diarrhea and thrombocytopenia) identifying
the MTD of epirubicin as 35 mg/m2. Of the 14 cases assessable for
response, partial response was documented in 2 patients, and stable
disease in 7, giving an overall disease control rate of 64.2%."

"The comparison of pre- and post-therapy ERBB2 and EGFR values was not
statistically significant between the subgroups of patients regarding
responsiveness to treatment. The recommended dose of epirubicin for
phase II studies is 30 mg/m2 in combination with gefitinib at the daily
dose of 250 mg."

"Pharmacodynamic studies did not identify any biomarker predictive of
response," scientists indicated.
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