Annals of Oncology Advance Access published online on September 29, 2008
Annals of Oncology, doi:10.1093/annonc/mdn590
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Long-term outcome prediction by clinicopathological risk classification algorithms in node-negative breast cancer—comparison between Adjuvant!, St Gallen, and a novel risk algorithm used in the prospective randomized Node-Negative-Breast Cancer-3 (NNBC-3) trial
1 Department of Obstetrics and Gynecology
2 Department of Medical Biometrics, Epidemiology and Informatics
3 Department of Pathology, Johannes Gutenberg University, Mainz
4 Leibniz Research Centre for Working Environment and Human Factors (IfADo) at the Dortmund University of Technology, Dortmund
5 Siemens Medical Solutions, Diagnostics GmbH, Leverkusen, Germany
6 Institute of Pathology, Centre Hospitalier Universite Vaudois, University of Lausanne, Switzerland
7 German Breast Group, Neu-Isenburg and Goethe University, Frankfurt
8 Department of Obstetrics and Gynecology, Technical University of Munich, Munich
9 Department of Gynecology, University Hospital, Halle/Saale, Germany
* Correspondence to: Dr M. Schmidt, Department of Obstetrics and Gynecology, Johannes Gutenberg University, Medical School, Langenbeckstr. 1, 55131 Mainz, Germany. Tel: +49-6131-172683; Fax: +49-6131-175673; E-mail: marcus.schmidt{at}frauen.klinik.uni-mainz.de
Background: Defining risk categories in breast cancer is of considerable clinical significance. We have developed a novel risk classification algorithm and compared its prognostic utility to the Web-based tool Adjuvant! and to the St Gallen risk classification.
Patients and methods: After a median follow-up of 10 years, we retrospectively analyzed 410 consecutive node-negative breast cancer patients who had not received adjuvant systemic therapy. High risk was defined by any of the following criteria: (i) age <35 years, (ii) grade 3, (iii) human epithelial growth factor receptor-2 positivity, (iv) vascular invasion, (v) progesterone receptor negativity, (vi) grade 2 tumors >2 cm. All patients were also characterized using Adjuvant! and the St Gallen 2007 risk categories. We analyzed disease-free survival (DFS) and overall survival (OS).
Results: The Node-Negative-Breast Cancer-3 (NNBC-3) algorithm enlarged the low-risk group to 37% as compared with Adjuvant! (17%) and St Gallen (18%), respectively. In multivariate analysis, both Adjuvant! [P = 0.027, hazard ratio (HR) 3.81, 96% confidence interval (CI) 1.16–12.47] and the NNBC-3 risk classification (P = 0.049, HR 1.95, 95% CI 1.00–3.81) significantly predicted OS, but only the NNBC-3 algorithm retained its prognostic significance in multivariate analysis for DFS (P < 0.0005).
Conclusion: The novel NNBC-3 risk algorithm is the only clinicopathological risk classification algorithm significantly predicting DFS as well as OS.
Adjuvant!, breast cancer, node-negative, prognosis, St Gallen
Received for publication April 5, 2008. Revision received July 24, 2008. Accepted for publication July 25, 2008.