Objectives: To evaluate the efficacy and safety of combing aromatase inhibitor (AI) and cyclooxygenase-2 (COX-2) inhibitor neoadjuvantly in postmenopausal patients with invasive hormone-sensitive breast cancer.
Methods: Eighty-two patients were randomly assigned to receive exemestane 25mg daily and celecoxib 400mg twice daily (group A, n=30), exemestane 25mg daily (group B, n=24) and letrozole 2.5mg daily (group C, n=28).
Results: All groups showed clinical responses (58.6% for group A, 54.5% for group B and 62.0% for group C) and decrease in tumor area (61.8% for group A, 58.1% for group B and 55.7% for group C). 3 out of 5 patients with complete clinical response were observed from group A and 2 out of 69 patients operated with pathologic complete response were observed in group C. The mean microscopic tumor size was 2.53 cm for group A, 3.05 cm for group B and 2.10 cm for group C. The differences were only statistically significant when group C was compared with group B (P=0.025). The toxicity profiles among groups were satisfactory.
Conclusion: AI is effective in treating breast cancer and may be safely used preoperatively. The addition of COX-2 inhibitor may provide additional benefit.