551 Background: Oral UFT and classical (c-) CMF provide similar response rates in patients (pts) with metastatic BC (CMF: 36.1%, UFT: 39.3%). In a postoperative setting, these regimens showed comparable effectiveness in terms of odds reductions in relapse-free survival (RFS) (CMF: 23.5%, UFT: 21.0%), but data fromrandomized controlled trials (RCT) is not sufficient. Methods: We conducted a RCT to study the efficacy and toxicity of 2-year oral UFT as compared with c-CMF in pts with Stage I - IIIA node-negative, pathologically high-risk BC in a postoperative setting. In the CMF arm, pts received 6 cycles of c-CMF (C: 100 mg po, days 1 to 14, M: 40 mg/m2 iv, days 1 and 8, F: 500 mg/m2 iv, days 1 and 8). In the UFT arm, pts received UFT at 300 mg/m2/day po for 2 years. Tamoxifen (20 mg/day) was administered for 5 years if ER or PgR was positive or unknown. The primary endpoint was RFS. Overall survival (OS), toxicity, and quality of life were secondary endpoints. The statistical hypothesis was non- inferiority of UFT in terms of RFS (95% CI of HR: <1.30). Results: From October 1996 through March 2001, a total of 733 pts were enrolled of whom 707 pts were analyzed. Patients’ characteristics were well balanced between the two arms. Median follow-up time was 6.1 years. At 5 years the RFS rate was 88.2% in the CMF arm and 87.7% in the UFT arm, and OS rates were 96.0% and 96.1%, respectively. Hazard ratios of the UFT arm to the CMF arm were 1.05 (95% CI: 0.69–1.57) for RFS and 0.88 (95% CI: 0.48–1.63) for OS. The toxicity profile differed between the groups. Major grade 3 or higher adverse events were as follows: leukopenia (CMF: 3.1%, UFT: 0.3%, p=0.006), neutropenia (CMF: 5.5%, UFT: 3.5%, p=0.27), elevation of total bilirubin (CMF: 0.3%, UFT: 5.5%, p=0.00001), elevation of GOT (CMF: 1.4%, UFT: 5.7%, p=0.004), elevation of GPT (CMF: 5.1%, UFT: 8.9%, p=0.08), nausea/vomiting (CMF: 2.8%, UFT: 1.1%, p=0.18) and diarrhea, (CMF: 0.3%, UFT: 2.0%, p=0.04). Conclusions: Our results suggest that UFT is a promising alternative to CMF as postoperative adjuvant chemotherapy in women with node-negative, high-risk breast cancer. No significant financial relationships to disclose.
