Annals of Oncology Advance Access originally published online on February 21, 2008
Annals of Oncology 2008 19(6):1090-1096; doi:10.1093/annonc/mdn005
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breast cancer |
Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial
1 Helios Klinikum Berlin Buch, Academic Hospital of the University Charite Berlin, Berlin, Germany
2 Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA
3 Klinikum Offenbach, Offenbach, Germany
4 Frontier Science, Kincraig, Kingussie, UK
5 Vall d'Hebron University Hospital, Barcelona, Spain
6 Andrew Love Cancer Centre, Geelong, Australia
7 NCRN Coordinating Centre, University of Leeds, UK
8 Istituto Nazionale Tumori, Milan, Italy
9 Royal Marsden Hospital, Sutton/Surrey, UK
10 Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA
11 Medical Oncology Clinic and BrEAST Data Centre, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium
12 Hoffmann-La Roche, 4070 Basel, Switzerland
13 Tatarstan Republic Oncological Hospital, Kazan, Russian Federation
14 Chinese Academy of Medical Science, Beijing, China
15 Klinikum Lippe Lemgo, Lemgo, Germany
16 Hospital Clinico Universitario de Zaragoza, Spain
17 Veterans General Hospital, Taipei, Taiwan
18 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
19 Hospital Clinico Universitario de Valencia, Valencia, Spain
20 Medical University of Gdansk, Gdansk, Poland
21 Bristol Oncology Centre, Bristol, UK
22 LKH Voecklabruck, Voecklabruck, Austria
23 Hospital Regional Issste Merida, Merida, Mexico
24 Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand
25 Department of Medicine, European Institute of Oncology, Milan, Italy
26 School of Public Health, University of Sydney, Sydney, Australia
27 Department of Medicine and Breast International Group, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium
28 Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
* Correspondence to: Prof R. D. Gelber, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA. Tel: +1 617 632-3603, Fax: +1 617 632-5444; E-mail: gelber{at}jimmy.harvard.edu
Background: Trastuzumab (Herceptin®) improves disease-free survival (DFS) and overall survival for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess the magnitude of its clinical benefit for subpopulations defined by nodal and steroid hormone receptor status using data from the Herceptin Adjuvant (HERA) study.
Patients and methods: HERA is an international multicenter randomized trial comparing 1 or 2 years of trastuzumab treatment with observation after standard chemotherapy in women with HER2-positive breast cancer. In total, 1703 women randomized to 1-year trastuzumab and 1698 women randomized to observation were included in these analyses. Median follow-up was 23.5 months. The primary endpoint was DFS.
Results: The overall hazard ratio (HR) for trastuzumab versus observation was 0.64 [95% confidence interval (CI) 0.54–0.76; P < 0.0001], ranging from 0.46 to 0.82 for subgroups. Estimated improvement in 3-year DFS in subgroups ranged from +11.3% to +0.6%. Patients with the best prognosis (those with node-negative disease and tumors 1.1–2.0 cm) had benefit similar to the overall cohort (HR 0.53, 95% CI 0.26–1.07; 3-year DFS improvement +4.6%, 95% CI –4.0% to 13.2%).
Conclusions: Adjuvant trastuzumab therapy reduces the risk of relapse similarly across subgroups defined by nodal status and steroid hormone receptor status, even those at relatively low risk for relapse.
Key words: adjuvant therapy, breast cancer, disease-free survival, HER2-oncogene, subgroubs, trastuzumab
Received for publication October 24, 2007. Accepted for publication January 2, 2008.
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