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  • / Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin, and trastuzumab (TCH).

Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin, and trastuzumab (TCH).

Abstract

Authors

null

V. Valero

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

Organizations

University of Texas M. D. Anderson Cancer Center, Houston, TX, University of California, Los Angeles School of Medicine/Translational Oncology Research International, Los Angeles, CA, Frauenklinik vom Roten Kreuz, Munich, Germany, Virginia Cancer Specialists, US Oncology, Fairfax, VA, Center for Oncology, Klinika Nowotworow, Warszawa, Poland, Hospital Universitario Gregorio Marañón, Madrid, Spain, Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada, Cancer International Research Group, Edmonton, AB, Canada, CIRG, Paris, France, Keck School of Medicine of the University of Southern California, Los Angeles, CA, University Medical Center Hamburg-Eppendorf, Hubertus Wald Cancer Center, Hamburg, Germany, Irish Clinical Oncology Research Group and Molecular Therapeutics for Cancer, Dublin, Ireland

Research Funding

Pharmaceutical/Biotech Company

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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Abstract Details

Meeting

2011 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer - HER2/ER

Track

Breast Cancer

Sub Track

HER2+

Clinical Trial Registration Number

NCT00021255

Citation

J Clin Oncol 29: 2011 (suppl; abstr 553)

Abstract #

553

Poster Bd #

3C

Abstract Disclosures

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