Abstract
11081 Risk-assessment in N0 breast cancer is still controversial. In line with St. Gallen, only few patients (pts) are considered at such low risk of relapse, that adjuvant chemotherapy could be avoided. Various groups have started clinical trials aimed at improved risk-assessment by gene or protein analysis of the primary tumor. We launched the NNBC 3-Europe trial asking the following questions: Is the identification of low- risk pts by the invasion markers uPA and PAI-1 more effective than by St. Gallen criteria? Is adjuvant chemotherapy using an anthracycline- taxane sequence superior to standard FEC in N0 high-risk pts? The centres of the NNBC 3 trial had to choose their mode of risk- assessment (either St. Gallen criteria or uPA/PAI-1) prior to recruitment. High-risk pts receive chemotherapy randomly assigned to FEC-100*3 followed by Docetaxel-100*3 (FEC-Doc), or FEC-100*6. No adjuvant chemotherapy is given to low-risk pts. Pts with hormone receptor positive tumors receive standard endocrine therapy. To date, 1206 pts in 57 centres have been registered. Using fresh frozen tumor tissue, uPA and PAI-1 are tested in nine laboratories; inter-laboratory quality assurance is performed. In 141 of 1188 evaluable pts, St Gallen criteria were used. In the biological risk-assessment group, 150 of 1047 tumors (14.3%) were well differentiated, thus regarded as low-risk. Using both, tumor grade and uPA/PAI-1, 35.3% of the pts were considered low-risk, whereas the remaining 64.7% high-risk pts received adjuvant chemotherapy (FEC-Doc, n=334, or FEC, n=343). Multicenter prospective risk assessment based on testing of fresh frozen (or paraffin- embedded) tumor tissue is sophisticated. All trials with similar approach (MINDACT, TAILORx) had a long preparation phase including thorough assay validation. The ongoing NNBC-3 trial demonstrates that inclusion of pts based on testing of fresh frozen material is feasible in a routine setting. Risk-group distribution is as expected. The study is planned to recruit 5,700 pts and it is performed in cooperation with the EORTC Patho-Biology Group, the German AGO Breast Group, and the German Breast Group (GBG). Unrestricted grants by Sanofi-Aventis and Pfizer. [Table: see text]
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