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Annals of Oncology Advance Access originally published online on January 3, 2008
Annals of Oncology 2008 19(5):861-870; doi:10.1093/annonc/mdm551
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Triple-negative high-risk breast cancer derives particular benefit from dose intensification of adjuvant chemotherapy: results of WSG AM-01 trial

O. Gluz1,*, U. A. Nitz1, N. Harbeck3, E. Ting2, R. Kates3, A. Herr4, W. Lindemann5, C. Jackisch6, W. E. Berdel7, H. Kirchner8, B. Metzner9, F. Werner1, G. Schütt1, M. Frick1, C. Poremba2, R. Diallo-Danebrock2, S. Mohrmann On behalf of the West German Study Group1

1 West German Study Group, Breast Centre, Department of Gynecology and Obstetrics
2 Department of Pathology, University Hospital, Duesseldorf
3 Department of Obstetrics and Gynecology, Technical University of Munich, Munich
4 Department of Clinical Genetics, University Hospital, Technical University, Dresden
5 Department of Hematology/Oncology, Catholic Hospital, Hagen
6 Department of Gynecology and Obstetrics, City Hospital, Offenbach
7 Department of Hematology/Oncology, University Hospital, Muenster
8 Department of Hematology/Oncology, Siloah Clinic, Hannover
9 Department of Hematology/Oncology, City Hospital, Oldenburg, Germany

* Correspondence to: Dr O. Gluz, West German Study Group, Breast Centre, University Hospital of Duesseldorf, Moorenstrasse 5, 40225 Duesseldorf, Germany. Tel: +49-2161-5662311; Fax: +49-2161-5662319; E-mail: oleg.gluz{at}wsg-online.com

Background: This paper evaluates the prognostic and predictive impact of protein expression of various molecular markers in high-risk breast cancer (HRBC) patients with >9 involved lymph nodes, who received different chemotherapy dose-intensification strategies within a prospective randomized WSG AM-01 trial.

Materials and methods: Paraffin-embedded tumors from 236 patients, who were randomly assigned to dose-dense conventional chemotherapy with four cycles of E90C600 followed by three cycles of C600M40F600 every 2 weeks (DD) or a rapidly cycled tandem high-dose regimen with two cycles of E90C600 every 2 weeks followed by two cycles of E90C3000Thiotepa400 every 3 weeks (HD), were available for retrospective central pathological review (116 HD/120 DD). Expression of estrogen receptor (ER), progesterone receptor (PR), MIB-1, epidermal growth factor receptor, and Her-2/neu was evaluated immunohistochemically using tissue microarrays. Results were correlated with follow-up data and treatment effects by proportional hazard Cox regression models (including interaction analysis).

Results: After a median follow-up of 61.7 months, 5-year event-free survival (EFS) as well as overall survival (OS) rates for the 236 patients were significantly better in the HD arm: EFS: 62% versus 41% [hazard ratio (HR) = 0.60, 95% CI 0.43–0.85, P = 0.004]; OS: 76% versus 61% (HR = 0.58, 95% CI 0.39–0.87, P = 0.007). In multivariate analysis, HD, tumor size <3 cm, positive PR, negative MIB-1 staining, and grade 1/2 were associated with favorable outcome. Interaction analysis showed that regarding predictive effects, triple negative (ER/PR/Her-2/neu) and G3 tumors derived most benefit from HD.

Conclusion: Tandem HD improves both EFS and OS in HRBC. This therapy effect may be partly attributable to superior efficacy in the subgroup of triple-negative tumors and/or G3 with their poor prognostic marker profile.

Key words: basal-like, breast cancer, high dose chemotherapy, triple negative, breast cancer

Received for publication July 28, 2007. Accepted for publication November 2, 2007.


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