DNA repair deficiency biomarkers identify HR+/HER2- breast cancer patients who may benefit from veliparib/carboplatin: results from the I-SPY 2 TRIAL

Author(s): L. van 't Veer, L. Esserman, A. Sanil, A. Glas, T. Severson, S. Linn, L. Brown-Swigart, G. Hirst, I-SPY 2 TRIAL Investigators, O. Olapade, H .Rugo, D. Berry, D. M. Wolf, and C. Yau

Background In I-SPY 2, HER2- patients were adaptively randomized to receive standard chemotherapy or the PARP inhibitor veliparib with carboplatin (V/C) and chemotherapy. V/C graduated in the triple-negative (TN) subtype, and we have previously shown that DNA repair deficiency signatures [PARPi-7 and BRCAness] … Continued

Functional Subtyping with BluePrint 80-gene profile identifies distinct triple positive subtypes with and without trastuzumab/pertuzumab/chemo-sensitivity

Author(s): Pat Whitworth, Peter Beitsch, Paul Baron, Michael C Rotkis, James V Pellicane, Mary Murray, Carrie L Dul, Angela M Mislowsky, Charles H Nash, Paul D Richards, Laura A Lee, Lisette Stork-Sloots, Femke de Snoo, Sarah Untch, Mark Gittleman, Stephanie Akbari, Jennifer Beatty

Background and Aim Classification into molecular subtypes is important for the selection of therapy for patients with breast cancer. Previous analyses demonstrated that breast cancer subtypes have distinct clinical outcome (Glück, BCRT 2013). The aim of the prospective NBRST study is to compare a … Continued

Genomic Profile of Breast Cancer: Cost-effectiveness Analysis from the Spanish National Healthcare System Perspective

Publication Name: Expert Review of Pharmacoeconmics & Outcomes Research

Author(s): Miguel Ángel Seguí, Carlos Crespo, Javier Cortés, Ana Lluch, Max Brosa, Virginia Becerra, Sebastián Matias Chiavenna, and Alfredo Gracia

Background: Cost–effectiveness analysis of MammaPrint® (70-gene signature) in the diagnosis of early breast cancer as a prognosis assay to study the risk of tumor recurrence to administer adjuvant chemotherapy. Methods: Markov model assuming a cohort of 60-year-old women with breast cancer. … Continued

Chemosensitivity predicted by BluePrint 80-gene functional subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST)

Publication Name: Annals of Surgical Oncology

Author(s): Whitworth P, Stork-Sloots L, de Snoo FA, Richards P, Rotkis M, Beatty J, Mislowsky A, Pellicane JV, Nguyen B, Lee L, Nash C, Gittleman M, Akbari S, Beitsch PD.

PURPOSE: The purpose of the NBRST study is to compare a multigene classifier to conventional immunohistochemistry (IHC)/fluorescence in situ hybridization (FISH) subtyping to predict chemosensitivity as defined by pathological complete response (pCR) or endocrine sensitivity as defined by partial response. … 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