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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