70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

Publication Name: New England Journal of Medicine

Author(s): Fatima Cardoso, M.D., Laura J. van’t Veer, Ph.D., Jan Bogaerts, Ph.D., Leen Slaets, Ph.D., Giuseppe Viale, M.D., Suzette Delaloge, M.D., Jean-Yves Pierga, M.D., Ph.D., Etienne Brain, M.D., Ph.D., Sylvain Causeret, M.D., Mauro DeLorenzi, Ph.D., Annuska M. Glas, Ph.D., Vassilis Golfinopoulos, M.D., Ph.D., Theodora Goulioti, M.D., Susan Knox, M.A., Erika Matos, M.D., Bart Meulemans, M.Sc., Peter A. Neijenhuis, M.D., Ulrike Nitz, M.D., Ph.D., Rodolfo Passalacqua, M.D., Peter Ravdin, M.D., Isabel T. Rubio, M.D., Mahasti Saghatchian, M.D., Tineke J. Smilde, M.D., Ph.D., Christos Sotiriou, M.D., Ph.D., Lisette Stork, M.Sc., Carolyn Straehle, Ph.D., Geraldine Thomas, Ph.D., Alastair M. Thompson, M.D., Jacobus M. van der Hoeven, M.D., Ph.D., Peter Vuylsteke, M.D., René Bernards, Ph.D., Konstantinos Tryfonidis, M.D., Emiel Rutgers, M.D., Ph.D., and Martine Piccart, M.D., Ph.D., for the MINDACT Investigators*

BACKGROUND The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard … Continued

European Inter-Institutional Impact Study of MammaPrint

Publication Name: The Breast

Author(s): P.G. Cusumano, D. Generali, E. Ciruelos, L. Manso, I. Ghanem, E. Lifrange, G. Jerusalem, J. Klaase, F. de Snoo, L. Stork-Sloots, L. Dekker-Vroling, M. Lutke Holzik

Aim To measure the impact of MammaPrint on adjuvant treatment decisions and to analyze the agreement in treatment decisions between hospitals from 4 European countries for the same patient cohort. Methods Breast cancer patients were prospectively enrolled and MammaPrint was … Continued

Risk estimations and treatment decisions in early stage breast cancer: Agreement among oncologists and the impact of the 70-gene signature.

Publication Name: European Journal of Cancer

Author(s): Drukker CA, van den Hout HC, Sonke GS, Brain E, Bonnefoi H, Cardoso F, Goldhirsch A, Harbeck N, Honkoop AH, Koornstra RHT, van Laarhoven HWM, Portielje JEA, Schneeweiss A, Smorenburg CH, Stouthard J, Linn SC, Schmidt MK

BACKGROUND: Clinical decision-making in patients with early stage breast cancer requires adequate risk estimation by medical oncologists. This survey evaluates the agreement among oncologists on risk estimations and adjuvant systemic treatment (AST) decisions and the impact of adding the 70-gene … Continued

Mammographic screening detects low-risk tumor biology breast cancers

Publication Name: Breast Cancer Research and Treatment

Author(s): Drukker CA, Schmidt MK, Rutgers EJT, Cardoso F, Kerlikowske K, Esserman LJ, van Leeuwen FE, Pijnappel RM, Slaets L, Bogaerts J, Van't Veer LJ

Overdiagnosis of breast cancer, i.e. the detection of slow-growing tumors that would never have caused symptoms or death, became more prevalent with the implementation of population-based screening. Only rough estimates have been made of the proportion of patients that are … Continued

Long-term impact of the 70-gene signature on breast cancer outcome

Publication Name: Breast Cancer Research and Treatment

Author(s): C. A. Drukker, H. van Tinteren, M. K. Schmidt, E. J. Th. Rutgers, R. Bernards, M. J. van de Vijver, L. J. van’t Veer

Several studies have validated the prognostic value of the 70-gene prognosis signature (MammaPrintR), but long-term outcome prediction of these patients has not been previously reported. The follow-up of the consecutively treated cohort of 295 patients (<53 years) with invasive breast … Continued

MammaPrint Molecular Diagnostics on Formalin-Fixed, Paraffin-Embedded Tissue.

Publication Name: The Journal of Molecular Diagnostics

Author(s): Sapino A, Roepman P, Linn SC, Snel MHJ, Delahaye LJMJ, van den Akker J, Glas AM, Simon IM, Barth N, de Snoo FA, van 't Veer LJ, Molinaro L, Berns EMJJ, Wesseling J, Riley LB, Anderson D, Nguyen B, Cox

MammaPrint, a prognostic 70-gene profile for early-stage breast cancer, has been available for fresh tissue. Improvements in RNA processing have enabled microarray diagnostics for formalin-fixed, paraffin- embedded (FFPE) tissue. Here, we describe method optimization, validation, and performance of MammaPrint using … Continued

Performance Characteristics of the MammaPrint Breast Cancer Diagnostic Gene Signature

Publication Name: Personalized Medicine

Author(s): Leonie JM Delahaye, Diederik Wehkamp, Arno N Floore, Rene Bernards, Laura J van‘t Veer1 & Annuska M Glas

The analytical performance of multigene signatures depends on many parameters, including precision, repeatability, reproducibility and intratumor heterogeneity. Indicators such as sensitivity, specificity, positive predictive value and negative predictive value are typically used to define the clinical performance of a diagnostic … Continued

Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy

Publication Name: Breast Cancer Research and Treatment

Author(s): Stefan Glück, Femke de Snoo, Justine Peeters, Lisette Stork-Sloots, George Somlo

The aim of this study was to analyze the correlation between the pathologic complete response (pCR) rate after neoadjuvant chemotherapy and long-term outcome (distant metastases-free survival [DMFS]) in patients with early-stage breast cancer using BluePrint and MammaPrint molecular subtyping versus … Continued

A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study

Publication Name: International Journal of Cancer

Author(s): C.A. Drukker, J.M. Bueno-de-Mesquita, V.P. Retèl, W.H. van Harten, H. van Tinteren, J. Wesseling, R.M.H. Roumen, M. Knauer, L.J. van ’t Veer, G.S. Sonke, E.J.T. Rutgers, M.J. van de Vijver, S.C. Linn

The 70-gene signature (MammaPrint™) has been developed on retrospective series of breast cancer patients to predict the risk of breast cancer distant metastases. The microarRAy-prognoSTics-in-breast-cancER (RASTER) study was the first study designed to prospectively evaluate the performance of the 70-gene … Continued

The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase

Publication Name: EUROPEAN JOURNAL OF CANCER

Author(s): Emiel Rutgers, Martine J. Piccart-Gebhart, Jan Bogaerts, Suzette Delaloge, Laura Van ‘t Veer

Background: The MINDACT (Microarray In Node-negative and 1–3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. … Continued