ABSTRACT
This adjuvant randomized trial demonstrated significantly better relapse-free survival (RFS: 63% vs. 53%, p 0.009) and OS (77% vs. 70%, p 0.03) for an anthracycline-containing regimen (CEF: cyclophosphamide, epirubicin, and 5-FU) over Bonadonna-CMF [5] in premenopausal breast cancer patients with involved axillary nodes. Patients had either lumpectomy with radiation (RT) or mastectomy, and were then randomized to 6 cycles of CMF or CEF. Study endpoints were RFS, OS, quality of life (QOL), and toxicity. Stratification was according to type of surgery (as above), estrogen receptor and progesterone receptor status, and number of involved nodes (1-3, 4-10, 10). The advantage of CEF was observed despite significantly greater toxicity (including 5 cases of acute myeloid leukemia, 4 of which were fatal) and lower delivered dose intensity (77% for CEF, 88% for CMF, p 0.0001). Women with 3 positive nodes had more benefit from CEF (hazard ratio for RFS 1.41, 95% confidence interval [CI] 1.02-1.95; OS 82% CEF vs. 78% CMF) than women with 1-3 positive nodes (hazard ratio 1.26, 95% CI 0.91-1.74; OS 70% CEF vs. 58% CMF). QOL was lower with CEF; however, by 6 months after completion of CT, there was no difference in QOL scores for the two treatment groups.
