Abstract
512 Background: AT is one of the most active regimens in ABC (response rates=44–83%). Methods: A Phase III Intergroup trial was completed to test adjuvant AT vs. AC. Women with 1–3 N + or N - and T-size > 1cm were randomized to four cycles of AT (60 mg/m2/60 mg/ m2) or AC (60 mg/m2/600 mg/m2) q 3 wk x 4. After chemotherapy, pts with ER + and/ or PR + received tam for 5 years. Patients were stratified by nodal, hormone receptor (ER+ PR+, ER+PR-, ER-PR+, ER-PR-, ER/PR unk) and menopausal status. The primary endpoint was DFS. With 2778 patients (including 10% ineligible), this study had 83% power to detect a 25% reduction in DFS failure hazard rate using AT(assuming a 78% 5-yr DFS on the AC arm). Results: 2952 pts were randomized between 7/30/98 and 1/21/00. 2889 were eligible and analyzable. Arms were balanced for age, hormone receptor, menopause, nodes, surgery, grade and T-size: median age 51; 64% ER +; 65% LN-; grade: 10% low, 38% int., 46% high; and median T-size - 2.0 cm. Febrile neutropenia occurred i...
Published Version
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