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recurrence risk of node-negative and er-positive early stage breast cancer patients by combining recurrence score, patho

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recurrence risk of node-negative and er-positive early stage breast cancer patients by combining recurrence score, patho

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    1. Recurrence Risk of Node-Negative and ER-Positive Early Stage Breast Cancer Patients by Combining Recurrence Score, Pathologic, and Clinical Information: A Meta Analysis Approach

    3. Objectives Develop an integrated risk estimate RS-Pathology-Clinical (RSPC) assessment. Compare this new tool with RS alone and with pathology and clinical features alone Expected that among ER+/N- breast cancer, RSPC will Decrease number of patients classified as intermediate risk by RS Refine assessments of DR risk when RS and standard measures are discordant

    5. Measures Included in Meta-Analysis

    6. Distribution of RS, Tumor Grade, Tumor Size and Age1735 Patients from B-14 and TransATAC

    7. Statistical Methods

    8. Pre-Defined Risk Groups RS (standard definition) Low: RS < 18 Intermediate: 18 = RS < 31 High: RS = 31

    9. Meta-Analysis Likelihood Ratio Tests (All Patients)

    10. Proportion of Node-Negative Patients Classified asLow, Intermediate and High Risk by RS and RSPC

    11. Cross Classification by Risk Group: RSPC vs. RS

    12. RSPC is for Recurrence Risk,Not Prediction of Chemotherapy Benefit RS is Predictive of Chemotherapy Benefit in ER(+) Patients Node(-): NSABP B-20 [4] Node(+): SWOG 8814 [5] Work is ongoing to assess the use of RS with RSPC in prediction of chemotherapy benefit Currently, RS used alone is the recommended method to predict chemotherapy benefit.

    13. Summary and Conclusions RSPC recurrence risk assessment combining RS with age, tumor grade and tumor size significantly improves prognostic power over RS alone RSPC recurrence risk assessment decreases number of patients classified as intermediate risk RSPC refines assessment of recurrence risk when RS and standard measures are discordant As a meta-analysis, this analysis reflects all of the currently available evidence; it can be updated as new relevant datasets become available RSPC will be made available by Genomic Health as a free online tool after acceptance for publication

    14. Acknowledgements Women who participated in breast cancer clinical trials. NSABP: Funding from CTEP, National Cancer Institute, USA TransATAC: Janine Salter, Emma Quinn, Liz Mallon the ATAC trialists and pathologists ATAC Pathology sub-committee ATAC Steering Committee Funding from Breakthrough Breast Cancer and AstraZeneca Cancer Research UK GHI: Joff Baker, Maureen Cronin, Drew Watson, Carl Yoshizawa, Frederick L. Baehner, Audrey Goddard, Angela Chen, Meike Labusch, Jackie Brooks, Lauren Intagliata

    15. Reference (I) [1] Paik et al. A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. N Engl J Med 2004. 351(27):2817-2826. [2] Habel et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res 2006.8(3):R25. [3] Dowsett et al. Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients With Breast Cancer Treated With Anastrozole or Tamoxifen: A TransATAC Study. J Clin Oncol 2010 28:1829-1834. [4] Paik et al. Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor-Positive Breast Cancer . J Clin Oncol 2006; 24(23):3726-3734. [5] Albain et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol 2010; 11: 5565. [6] Harris et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2007; 25:5287-5312.

    16. Reference (II) [7] NCCN Clinical Practice Guidelines in OncologyTM Breast Cancer, (Version 1.2010) Accessed 2-59-10 at: http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf [8] Bryant J. Toward a More Rational Selection of Tailored Adjuvant Therapy: Data From the National Surgical Adjuvant Breast and Bowel Project. St. Gallen, 2005. [9] Goldstein et al. Prognostic Utility of the 21-Gene Assay in Hormone ReceptorPositive Operable Breast Cancer Compared With Classical Clinicopathologic Features. J Clin Oncol 2008; 26: 406371.

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