E2197: Phase III AT (doxorubicin/docetaxel) vs. AC (doxorubicin/cyclophosphamide) in the adjuvant treatment of node positive and high risk node negative breast cancer

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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 in 19%(AT) and 6%(AC). There were 3 treatment related deaths on the AT arm. There were 7 cases of MDS/AML on each arm. DFS/OS Results: As of 9/04, with a median follow-up of 53 mo, there were 197/1444 recurrences in the AT arm vs. 212/1445 in the AC arm and 104 deaths in the AT arm vs. 113 in the AC arm: HR (.95 CI) for OS = 1.09 (0.84–1.43), p=0.48. Conclusions: These results show a better than expected outcome with both regimens. At 53 mo. median follow-up, there is no difference in DFS or OS, although there are fewer events in the AT arm. Data for the subset analysis of prespecified stratifications: LN, menopause, and various ER/PR groups will be presented.

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