Benefit From Exemestane As Extended Adjuvant Therapy After 5 Years of Adjuvant Tamoxifen: Intention-to-Treat Analysis of the National Surgical Adjuvant Breast and Bowel Project B-33 Trial

摘要: Purpose Patients with early-stage, hormone receptor–positive breast cancer have considerable residual risk for recurrence after completing 5 years of adjuvant tamoxifen. In May 2001, the National Surgical Adjuvant Breast and Bowel Project (NSABP) initiated accrual to a randomized, placebo-controlled, double-blind clinical trial evaluate steroidal aromatase inhibitor exemestane as extended therapy in this setting. Methods Postmenopausal patients T1-3N1M0 who were disease free tamoxifen randomly assigned (25 mg/d orally) or placebo. Our primary aim was test whether prolongs disease-free survival (DFS). October 2003, results Cancer Institute Canada (NCIC) MA.17 showing benefit from letrozole setting necessitated termination B-33, unblinding, offering placebo group. Results At time unblindin...