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Medline ® Abstract for Reference 105

of 'Prognostic and predictive factors in early, nonmetastatic breast cancer'

105
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West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment.
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Gluz O, Nitz UA, Christgen M, Kates RE, Shak S, Clemens M, Kraemer S, Aktas B, Kuemmel S, Reimer T, Kusche M, Heyl V, Lorenz-Salehi F, Just M, Hofmann D, Degenhardt T, Liedtke C, Svedman C, Wuerstlein R, Kreipe HH, Harbeck N
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J Clin Oncol. 2016;34(20):2341.
 
PURPOSE: The 21-gene Recurrence Score (RS) assay is a validated prognostic/predictive tool in early hormone receptor-positive breast cancer (BC); however, only a few prospective outcome results have been available so far. In the phase III PlanBtrial, RS was prospectively used to define a subset of patients who received only endocrine therapy. We present 3-year outcome data and concordance analysis (among biomarkers/RS).
PATIENTS AND METHODS: Central tumor bank was established prospectively from PlanB (intermediate and high-risk, locally human epidermal growth factor receptor 2-negative BC). After an early amendment, HR-positive, pN0-1 patients with RS≤11 were recommended to omit chemotherapy.
RESULTS: From 2009 to 2011, PlanB enrolled 3,198 patients with a median age of 56 years; 41.1% had node-positive and 32.5% grade 3 disease. In 348 patients (15.3%), chemotherapy was omitted based on RS≤11. After 35 months median follow-up, 3-year disease-free survival in patients with RS≤11 and endocrine therapy alone was 98% versus 92% and 98% in RS>25 and RS 12 to 25 in chemotherapy-treated patients, respectively. Nodal status, central and local grade, the Ki-67 protein encoded by the MKI67 gene, estrogen receptor, progesterone receptor, tumor size, and RS were univariate prognostic factors for disease-free survival; only nodal status, both central and local grade, and RS were independent multivariate factors. Histologic grade was discordant between central and local laboratories in 44%. RS was positively but moderately correlated with the Ki-67 protein encoded by the MKI67 gene and grade and negatively correlated with progesterone receptor and estrogen receptor.
CONCLUSION: In this prospective trial, patients with enhanced clinical risk and omitted chemotherapy on the basis of RS≤11 had excellent 3-year survival. The substantial discordance observed between traditional prognostic markers and RS emphasizes the need for standardized assessment and supports the potential integration of standardized, well-validated genomic assays such as RS with clinicopathologic prognostic factors for chemotherapy indication in early hormone receptor-positive BC.
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Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA. oleg.gluz@wsg-online.com.
PMID