Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 29, Issue 25, Pages 3366-3373Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2011.35.0868
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Funding
- Genentech [35-03]
- GlaxoSmithKline
- sanofi aventis
- National Institutes of Health [U10-CA25224, RO1-CA129949]
- National Surgical Adjuvant Breast and Bowel Project [U10-CA12027, U10-CA69651, U10-CA37377, U10-CA69974]
- Breast Cancer Research Foundation
- Cancer and Leukemia Group B
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Purpose Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. Patients and Methods Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001). Conclusion These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects. J Clin Oncol 29:3366-3373. (C) 2011 by American Society of Clinical Oncology
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