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Nuvera and MD Anderson present new results on prediction of post-therapy nodal status at ASCO Breast Cancer Symposium

Woburn, MA - October 12, 2009. Nuvera Biosciences and researchers at University of Texas MD Anderson Cancer Center presented new findings on the ability to predict nodal status of a breast cancer patient based on response to neoadjuvant chemotherapy. The paper was presented at the ASCO Breast Cancer Symposium in San Francisco on October 9, 2009 by Dr. W. Fraser Symmans, Professor of Pathology, MD Anderson and a co-founder of Nuvera.

Abstract of the presentation

Relationship Between Genomic Prediction Of Chemosensitivity And Pathologic Nodal Status After Neoadjuvant Chemotherapy.

W. F. Symmans, C. Hatzis, F.A. Holmes, K.K. Hunt, J. Cotrina, J. Ferrer, E.A. Souchon, V. Valero, L. Pusztai, F. Meric-Bernstam
UT M.D. Anderson Cancer Center, Houston, TX; Nuvera Biosciences, Woburn, MA; U.S. Oncology, Houston, TX; INEN, Lima, Peru; University of Valencia, Spain; UT Lyndon B. Johnson Hospital, Houston, TX.

Background:Genomic prediction of tumor chemosensitivity might also predict residual nodal status after neoadjuvant therapy. This information could indicate the likelihood of residual nodal involvement, and assist in selecting patients for axillary-conserving surgery.

Methods:We developed a microarray-based genomic predictor of pathologic response after sequential taxane-anthracycline chemotherapy from 227 patients with HER2-negative breast cancer, and tested this in an independent, multicenter cohort of 113 patients who received neoadjuvant taxane-anthracycline chemotherapy containing paclitaxel or docetaxel. Predicted response from a diagnostic needle biopsy before NC was compared to pathologic nodal status after NC.

Results:Predicted chemotherapy responders (20%) were significantly more likely to be node-negative after treatment (positive predictive value (PPV) 83%, 95% confidence interval (CI) 61%-95%), compared to 57% overall. In 68 clinically node-positive patients, 37% converted to node-negative status after NC, and at a significantly higher rate among predicted responders (PPV 69%, CI 39%-91%). In 45 clinically node-negative patients, 71% remained node-negative after NC, including all predicted responders (PPV 100%, CI 69%-100%).

Conclusions:If clinically node-negative at diagnosis, predicted responders are expected to be node-negative after NC. Although SLNB before NC might determine the initial clinical nodal status, post-treatment SLNB would allow for axillary conservation. If clinically node-positive, predicted responders frequently convert to node-negative status. If SLNB is found to be accurate in these patients, selected patients may be offered axillary conservation. The potential utility of a combined clinical and genomic approach to axillary surgical management needs to be prospectively tested.