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Previous Volume 353:1659-1672 October 20, 2005 Number 16 Next

Martine J. Piccart-Gebhart, M.D., Ph.D., Marion Procter, M.Sci., Brian Leyland-Jones, M.D., Ph.D., Aron Goldhirsch, M.D., Michael Untch, M.D., Ian Smith, M.D., Luca Gianni, M.D., Jose Baselga, M.D., Richard Bell, M.D., Christian Jackisch, M.D., David Cameron, M.D., Mitch Dowsett, Ph.D., Carlos H. Barrios, M.D., Günther Steger, M.D., Chiun-Shen Huang, M.D., Ph.D., M.P.H., Michael Andersson, M.D., Dr.Med.Sci., Moshe Inbar, M.D., Mikhail Lichinitser, M.D., István Láng, M.D., Ulrike Nitz, M.D., Hiroji Iwata, M.D., Christoph Thomssen, M.D., Caroline Lohrisch, M.D., Thomas M. Suter, M.D., Josef Rüschoff, M.D., Tamás Süt, M.D., Ph.D., Victoria Greatorex, M.Sc., Carol Ward, M.Sc., Carolyn Straehle, Ph.D., Eleanor McFadden, M.A., M. Stella Dolci, Richard D. Gelber, Ph.D., for the Herceptin Adjuvant (HERA) Trial Study Team

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Burstein, H. J. Editorial by Hortobagyi, G. N. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Trastuzumab, a recombinant monoclonal antibody against HER2, has clinical activity in advanced breast cancer that overexpresses HER2. We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy.

Methods This international, multicenter, randomized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy.

Results Data were available for 1694 women randomly assigned to two years of treatment with trastuzumab, 1694 women assigned to one year of trastuzumab, and 1693 women assigned to observation. We report here the results only of treatment with trastuzumab for one year or observation. At the first planned interim analysis (median follow-up of one year), 347 events (recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant disease, or death) were observed: 127 events in the trastuzumab group and 220 in the observation group. The unadjusted hazard ratio for an event in the trastuzumab group, as compared with the observation group, was 0.54 (95 percent confidence interval, 0.43 to 0.67; P<0.0001 by the log-rank test, crossing the interim analysis boundary), representing an absolute benefit in terms of disease-free survival at two years of 8.4 percentage points. Overall survival in the two groups was not significantly different (29 deaths with trastuzumab vs. 37 with observation). Severe cardiotoxicity developed in 0.5 percent of the women who were treated with trastuzumab.

Conclusions One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer. (ClinicalTrials.gov number, NCT00045032 [ClinicalTrials.gov] .)

Source Information

Address reprint requests to Dr. Piccart-Gebhart at the Medicine Department, Jules Bordet Institute, Blvd. de Waterloo 125, 1000 Brussels, Belgium, or at martine.piccart{at}bordet.be. The authors' affiliations are listed in the Appendix.

Full Text of this Article

Related Letters:

Trastuzumab in Breast Cancer
Gilbert S. G., Banna G. L., Santoro A., Gounaris I. G., Katsumata M., Drebin J. A., Greene M. I., Mastrianni D. M., Mano M., Cameron D., Gelber R. D., the HERA Trial Study Team , Bryant J., Romond E., Perez E. A., Hortobagyi G. N., Barron H.
Extract | Full Text | PDF  
N Engl J Med 2006; 354:640-644, Feb 9, 2006. Correspondence

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