Anastrozole as neoadjuvant therapy for patients with hormone-dependent, locally-advanced breast cancer.

BACKGROUND We investigated the efficacy and safety of anastrozole as neoadjuvant therapy in a group of postmenopausal patients with locally-advanced breast cancer. PATIENTS AND METHODS This was an open-label trial, which recruited patients with histopathologically-confirmed unilateral, locally-advanced, estrogen-receptor-positive breast cancer (stage IIIA/B). All patients received anastrozole 1 mg/day for 3 months, after which the clinical response was evaluated. All patients with a complete or partial clinical response (cCR or cPR) underwent surgery (radical modified mastectomy), after which patients continued with the same therapy for two years or until progression. Primary end points were clinical response rate (cCR + cPR), surgery rate, pathological complete response rate and tolerability profile. RESULTS cCR and cPR were seen in 61/112 (54.5%) and 32/112 (28.6%) patients (n=112), respectively, giving an objective response rate of 93/112 (83%) patients. Following surgery in responding patients, 14/61 patients (23%) had a pathological CR and 47/61 (77%) patients had a pathological PR. CONCLUSION Neoadjuvant anastrozole treatment was highly effective and well-tolerated in postmenopausal women with hormone-dependent locally-advanced breast cancer.