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| |  Prognostic Marker Assessment for Early Breast Cancer Patients Reveals Discordance: Presented at ASCO By Brian Hoyle CHICAGO -- June 6, 2010 -- An exploratory analysis of the comparative risk assessments of the urokinase plasminogen activator/plasminogen activator inhibitor-1 (uPA/PAI-1)-based algorithm (UP) and the St. Gallen Clinico-Pathological Algorithm (CP) carried out in nearly 2,500 European patients diagnosed with early breast cancer has revealed "discordant results," especially for luminal tumours. The results-to-date from the Node-Negative-Breast Cancer 3 (NNBC 3)-Europe trial were reported in a poster presentation on June 5 by Eva Kantelhardt, MD, Department of Obstetrics and Gynecology, Martin-Luther-University Halle-Wittenberg, Halle, Germany, here at the 2010 Annual Meeting of the American Society for Clinical Oncology (ASCO). The NNBC 3-Europe trial was undertaken to evaluate the benefits of a sequential anthracycline-docetaxel regimen compared with the standard anthracycline therapy in high-risk, lymph node-negative breast cancer patients. Such patients who present with high levels of uPA/PAI-1 are considered to be at higher risk for metastasis, and so can benefit from adjuvant chemotherapy. "The biologic-based [UP] is not yet as common in Europe as in [North America]," explained Dr. Kantelhardt. "We were interested in comparing it to the [CP], since the implications for node-negative patients could be profound." From December 2002 to January 2009, the 153 participating centres recruited 4,149 patients. The patients' risk of breast cancer metastasis was assessed by CP (n = 1,652) or UP (n = 2,497). In the latter group, Bloom-Richardson G1 tumours were considered low risk (17.3% of patients) and high-risk patients were those with G3 tumours or who were younger than 35 years of age (31.2%). Risk assessment in patients with G2 tumours (52%) was done by an enzyme-linked immunosorbent assay quantitation of the levels of uPA/PAI-1 in tumours. Consistent with early breast cancer, most tumours were small (70.6% T1). Immunohistochemistry analyses revealed that tumours were oestrogen receptor-negative and progesterone receptor-negative in 16.9% of patients, and human epidermal growth factor receptor 2-positive in 13.2% of patients. Tumours judged to be high-risk by CP and low-risk by UP, and low-risk by CP and high-risk by UP revealed a striking difference for luminal tumours, which represented 71% of all tumours. Of the 1,783 luminal tumours, 560 produced discordant results; 203 were judged high-risk by CP but low-risk by UP, and 357 were judged low-risk by CP but high-risk by UP. This discordance was not trivial; the 560 tumours represented 31% of the luminal tumours and 24% of all tumours in the 2,497 patients. Additionally, 44 of the 242 triple-negative tumours (18%, and comprising 2% of all tumours) were considered low-risk by UP. None was considered low-risk by CP. "Luminal tumours are considered to have a good prognosis, and triple-negative tumours are considered a very bad prognosis, so these results are troubling," said Dr. Kantelhardt. The clinical significance of the results for patients in terms of the use of adjuvant chemotherapy will have to wait for now. "It will be about 1 year or so until we can say more," said Dr. Kantelhardt. "We need more patients." Funding for this study was provided by sanofi-aventis, Pfizer, and Roche. [Presentation title: Molecular Types and Prognostic Markers uPA/PAI-1 for 2,497 Early Breast Cancer Patients in the Multicenter, Randomized NNBC 3-Europe trial. Abstract 10539]
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