Background: The second interim analysis of the BCIRG001 trial at a median follow up of 55 months showed that adjuvant chemotherapy with TAC improves disease-free survival (DFS: HR 0.72; P=0.001) and overall survival (OS: HR 0.70; P=0.008) compared with FAC in women with operable node-positive breast cancer (N Engl J Med 2005;352:2302-13). We now report the final analysis of DFS, OS, and long-term safety after 10 years of follow-up.

Patients and Methods: Women with node-positive breast cancer were randomized to adjuvant treatment with either TAC or FAC every 3 weeks for 6 cycles. The primary end point was DFS. Secondary end points included OS and safety.

Results: Between June 1997 and June 1999, 1491 women (TAC N=745; FAC=746) from 20 countries were enrolled. Median follow up was 120 months. As of the cut-off date for this analysis (11 March 2010), there were a total of 620 DFS events (287 events with TAC; 333 with FAC). Ten-year DFS rates were 62% with TAC and 55% with FAC. TAC improved DFS irrespective of nodal status, hormone receptor status, and HER2/neu status. There have been 429 deaths (188 deaths with TAC; 241 with FAC) and 10-year OS rates were 76% with TAC and 69% with FAC. There was no statistically significant difference in rates of grade 3-4 congestive heart failure (CHF): TAC 3.5% vs FAC 2.3%, P=0.18. Deaths due to CHF have occurred in 2 patients in the TAC group and 4 patients in the FAC group. Rates of asymptomatic left ventricular dysfunction will be presented. A total of 6 patients have developed acute myeloid leukemia (TAC N=4; FAC N=2).

table 1

ITT, intention-to-treat

Conclusion: Ten-year follow up analysis of the BCIRG 001 trial confirmed that TAC significantly improves DFS and OS compared with FAC in women with node-positive early breast cancer.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr S4-3.