University of Texas M. D. Anderson Cancer Center, Houston, TX
V. Valero , D. J. Slamon , W. Eiermann , N. J. Robert , T. Pienkowski , M. Martin , J. R. Mackey , M. A. Lindsay , V. Bee-Munteanu , M. F. Press , G. Sauter , J. Crown
Background: Trastuzumab-chemotherapy-based adjuvant therapy (AC-TH or TCH) provide significant improvement in disease-free survival (DFS) and overall survival (OS) compared to chemotherapy-based adjuvant therapy (AC-T) in HER2 amplified breast cancer [Rommond E et al NEJM 2005 and Slamon D et al SABC 2009 and NEJM 2011 (in press)]. BCIRG 006 included 928 patients (pts) with stage I or II node-negative high risk HER-2 amplified breast cancer. We reported patient and tumor characteristics and efficacy outcome [disease-free survival (DFS) and overall survival (OS)] of this subset of pts. Methods: Pts were randomized to either AC (60/600 mg/m2 q3wk x4) followed by T (100 mg/m2 q3wk x 4) or AC followed by TH x 4 (H q1wk during chemotherapy then q3wk x 9 months) or TCH (75 mg/m2 / AUC6 q3wk x 6, and H q1wk during chemotherapy then q3wk x 7.5 months). High risk axillary node negative HER-2 amplified breast cancer was prospectively defined as any of these patient/tumor characteristics: age ≤35 years, or tumor >2cm, or negative ER and PR, or nuclear grade 2 or 3. Results: A total of 3,222 pts were accrued in BCIRG 006, 928 (29%) had node negative breast cancer. Patients had one or more patient/tumor characteristics: 7% <35 years; 50% tumor >2 cm; 49% ER and PR negative; grade 2 28%; and grade 3 68%; 50% had pT1 (459) and 48% had pT2 (441). 309 pts received AC-T, 310 in AC-TH and 309 in TCH. At a median follow-up of 65 months, there were 108 events and 42 deaths. DFS and OS for AC-T, AC-TH and TCH were 85.2%, 92.6%, 89.7% and 92.9%, 97.5% and 96.2%, respectively. DFS: hazard ratio of 0.47 with AC-TH, p-value=0.003 and 0.64 with TCH, p-value=0.057 as compared to AC-T. At this time, there is no statistically significant difference between the two trastuzumab-containing arms. Conclusions: Results of this trial confirm the significant benefit of trastuzumab-chemotherapy-based adjuvant therapy compared to adjuvant chemotherapy alone in high risk node negative HER-2 amplified breast cancer. Results of different node-negative subgroups will also be presented.
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