Phase III, randomized study of docetaxel (T) + capecitabine (X) (TX) followed by cyclophosphamide (C) + epirubicin (E) + X (CEX) vs. T followed by C + E + fluorouracil (F) (CEF) as adjuvant treatment for patients (pts) with early breast cancer (BC): An interim safety analysis

Abstract

719 Background: Adding X to T extends TTP and survival compared with T in pts with metastatic BC. We compared the efficacy/safety of TX followed by CEX vs. T followed by CEF as adjuvant therapy for early BC, and present the findings from a planned interim safety analysis. Patients and methods: Between Jan and Nov 2004, 327 of a planned population of 1500 pts were randomized to receive TX x3→ CEX x3 (T 60 mg/m2 d1 + X 900 mg/m2 bid d1–15→ C 600 mg/m2 d1, E 75 mg/m2 d1, X 900 mg/m2 bid d1–15, q3 wks) or T x3→ CEF x3 (T 80 mg/m2 d1→ C 600 mg/m2 d1, E 75 mg/m2 d1, F 600 mg/m2 d1). Leukocyte growth factors were not routinely administered. Pts had WHO performance status 0/1, pN+ BC or pN0 BC with tumor >2 cm and PgR-. The first 80 pts entered were included in the analysis (TX→ CEX, n=37; T→ CEF, n=43; 456 cycles). Results: 6 (8%) pts were withdrawn (T, n=1, peritonitis; XT, n=2, G3 diarrhea and neutropenic infection, nausea; CE75F, n=1, fatal pulmonary embolism; CE75X, n=2, G3 diarrhea). The most frequent G3/4 toxicity was neutropenic fever and infection (T80), non-neutropenic infection (T80), diarrhea (T60X), myalgia (T80), and fatigue (T80). Only 3 pts had G4 toxicity. G3 or 4 adverse events (CTCAE) by cycle are shown in Table. Conclusions: The safety of T60X→ CE75X is favorable compared to T80→ CE75F. T60X is associated with less neutropenic fever than T80. CE75X is generally well tolerated. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis, Roche Aventis, Roche Aventis, Lilly Oncology, Pierre Fabre, Roche