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)

Abstract

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+, 13% ER+ and 4% PR+. Ductal infiltrating carcinoma was observed in 91% of patients. Median number of positive regional lymph nodes was 3 (maximum 30). Surgery was lumpectomy in 33% and mastectomy in 67% of patients. A total of 471 cycles of AT (median 6 per patient, range 1–6) and 243 cycles of X (median 4.5, range 1–6) were administered. Median RDIs were 99% for A, 99% for T, and 91% for X. All patients were evaluable for toxicity. During AT treatment, the main grade 3–4 toxicities per cycle were neutropenia (3%), leukopenia (2%), constipation (1%), amenorrhea (1%) and diarrhea (0.4%). There were 9 episodes of febrile neutropenia in 8 patients. During X treatment, the main grade 3–4 toxicities per cycle were neutropenia (1%), amenorrhea (3%), cutaneous toxicity (1%), hand-foot syndrome (1%) and stomatitis (0.4%). Grade 1–2 hand-foot syndrome occurred in 21% of cycles. With median follow-up of 6.7 months, no relapses were seen. Treatment of the last patient will be completed by Easter 2005, and full toxicity data on all 115 patients will be presented. Conclusions: AT followed by sequential X as adjuvant treatment of node-positive BC patients is a well-tolerated regimen. No significant financial relationships to disclose.