• Edith A Perez, Edward H Romond, Vera J Suman, Jong-Hyeon Jeong, George Sledge, Charles E Geyer, Silvana Martino, Priya Rastogi, Julie Gralow, Sandra M Swain, Eric P Winer, Gerardo Colon-Otero, Nancy E Davidson, Eleftherios Mamounas, Jo Anne Zujewski, and Norman Wolmark.
• Edith A. Perez, Gerardo Colon-Otero, the Mayo Clinic, Jacksonville; Eleftherios Mamounas, University of Florida Health Cancer Center-Orlando Health, Orlando, FL; Edward H. Romond, University of Kentucky, Lexington, KY; Vera J. Suman, Mayo Clinic, Rochester, MN; Jong-Hyeon Jeong, Priya Rastogi, University of Pittsburgh; Nancy E. Davidson, University of Pittsburgh Cancer Institute; Norman Wolmark, Allegheny General Hospital, Pittsburgh, PA; George Sledge, Stanford University School of Medicine, Stanford; Silvana Martino, The Angeles Clinic and Research Institute, Santa Monica, CA; Charles E. Geyer Jr, Virginia Commonwealth University Massey Cancer Center, Richmond, VA; Julie Gralow, University of Washington/Seattle Cancer Care Alliance, Seattle, WA; Sandra M. Swain, MedStar Washington Hospital Center, Washington, DC; Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Jo Anne Zujewski, National Institutes of Health, Rockville, MD. perez.edith@mayo.edu.
• J. Clin. Oncol. 2014 Nov 20; 32 (33): 3744-52.

PurposePositive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2) -positive breast cancer were first reported in 2005. One of these reports, the joint analysis of North Central Cancer Treatment Group NCCTG N9831 (Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 (Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2), was updated in 2011. We now report the planned definitive overall survival (OS) results from this joint analysis along with updates on the disease-free survival (DFS) end point.MethodsIn all, 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials. The required number of events for the definitive statistical analysis for OS (710 events) was reached in September 2012. Updated analyses of overall DFS and related subgroups were also performed.ResultsMedian time on study was 8.4 years. Adding trastuzumab to chemotherapy led to a 37% relative improvement in OS (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.73; P < .001) and an increase in 10-year OS rate from 75.2% to 84%. These results were accompanied by an improvement in DFS of 40% (HR, 0.60; 95% CI, 0.53 to 0.68; P < .001) and increase in 10-year DFS rate from 62.2% to 73.7%. All patient subgroups benefited from addition of this targeted anti-HER2 agent.ConclusionThe addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence.© 2014 by American Society of Clinical Oncology.

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