Neoadjuvant use of 5-fluorouracil, epirubicin and cyclophosphamide with and without celecoxib for locally advanced breast cancer: A phase II study correlating response to celecoxib with high levels of COX-2 gene expression in the tumor

9603 Background: Chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) is efficacious and well tolerated in locally advanced breast cancer (LABC) patients. Celecoxib, a cyclooxygenase type 2 (COX-2) inhibitor, has both apoptotic and antiangiogenic activities, which may be of use in treatment of breast tumors which overexpress the COX-2 enzyme. We determined the tolerability, responses, and levels of COX-2 gene expression in tumors in LABC patients treated with FEC alone or a combination of FEC and celecoxib. Methods: Three cycles of FEC (F 500 mg/m2, E 75 mg/m2, cyclophosphamide 500 mg/m2), with or without C (400 mg bid), were given at 3-week intervals to women with histologically proven LABC. End point assessments were clinical (c) and pathologic (p) responses. The levels of COX-2 gene expression were determined using cDNA preparations from pretreatment tumor biopsy tissues by quantitative real time pCR, and were normalized to G3APDH gene expression. A total of 31 patients with a media...