Safety analysis of docetaxel (T) and doxorubicin (A) followed by sequential capecitabine (X) as adjuvant chemotherapy of patients with node-positive operable breast cancer (BC)

811 Background: T, A, and X have been shown to be very active drugs for the treatment of BC. Sequential administration of these chemotherapy agents has improved the toxicity profile versus concurrent administration. This study evaluated the safety profile of AT followed by sequential X in the adjuvant setting in patients with node-positive BC. Methods: Patients with histological diagnosis of stage II-III BC, positive regional lymph nodes, completed BC surgery, age ≥18 years, ECOG PS ≤ 2, and adequate bone marrow, renal, hepatic and cardiac function were included in the study. Prior chemotherapy, hormone therapy, and radiotherapy for BC were not allowed. Treatment: 6 courses of T 75 mg/m2 iv D1 and A 50 mg/m2 iv D1, every 21 days followed by 6 courses of X 2500 mg/m2/day po D1–14 and Vitamin B6 300 mg bid po D1–21 every 21- days. Results: Ninety-one of the 115 patients enrolled were included in this interim analysis. Median age:47 years (range 28–73), ECOG PS 0–1 100%, hormone receptor status was 64% ER/PR...