RESUMO
BACKGROUND: Anti-aromatase therapy is important in the treatment of breast cancer. Cyclooxygenase-2 (COX-2) inhibitors may be effective in chemoprevention. A proof of principle study was performed to investigate the efficacy and side effects including changes in lipid profiles of combining anti-aromatase therapy and COX-2 inhibitor preoperatively in hormone sensitive postmenopausal breast cancers. METHODS: From February 2002 to April 2003, 41 postmenopausal women with histologically proven LABC were recruited. The patients were randomly assigned to receive exemestane 25 mg daily and celecoxib 400 mg twice-daily (group A), exemestane 25 mg daily (group B) and letrozole 2.5 mg daily (group C. RESULTS: Observed clinical response rates were 61.5%, 60% and 54.5% for Groups A-C, respectively, with no pathologic complete response. Cholesterol levels for Group A dropped progressively and a statistical difference was observed between fifth week after operation and preoperative level (P = 0.026). In addition, Group A has significantly lowered cholesterol and LDL levels than Groups B and C after 18 weeks of treatment. CONCLUSION: The initial results show that different neoadjuvant anti-aromatase therapies has similar efficacy but the combination with celecoxib may have an advantageous effects on the serum lipid profiles.