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Poster display session

4122 - Summary of head-to-head comparisons of patient (pt) risk classifications by the 21-gene Recurrence Score (RS) assay and other genomic assays for early breast cancer (EBC)


11 Sep 2017


Poster display session


Targeted Therapy;  Breast Cancer


Zsuzsanna Varga


Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362


Z. Varga1, P. Sinn2, D. McCullough3, A. Lau3, M.C. Stöppler3, F.L. Baehner3, C. Chao4, A. Seidman5

Author affiliations

  • 1 Departement Pathologie Und Molekularpathologie, Universitätsspital Zürich, CH-8091 - Zürich/CH
  • 2 Sektionsleiter Gynäkopathologie, Pathologisches Institut, Heidelberg/DE
  • 3 Medical Affairs, Genomic Health, Inc., 94063 - Redwood City/US
  • 4 Medical Affairs, Genomic Health, Inc., Redwood City/US
  • 5 Department Of Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US


Abstract 4122


Many genomic assays that assess recurrence risk in EBC are prognostic, but they differ in risk group stratification, which can affect clinical utility. Prospective outcomes of > 50K pts treated based on 21-gene RS results have shown that pts with low RS EBC can safely forgo chemotherapy. Because of its extensive validation and wide clinical use, the RS assay is a common comparator in head-to-head studies with other assays.


Published/presented studies of the RS assay performed on same tumor samples with Breast Cancer Index (BCI), EndoPredict (EP) or EP+clinical features (EPclin), MammaPrint (MMP), and/or Prosigna (ROR) assays were reviewed. Study findings were summarized descriptively.


14 studies were found that compared the RS assay with BCI (1), BCI, EPclin, and ROR (1), EP/EPclin (2), MMP (6), and ROR (4). Overall discordance in risk stratification ranged from 43% to 66% between assays (Table). The RS assay classifies 12% of pts as high risk, compared with EP (63%), EPclin (48%), and MMP (46%), assays with low/high risk groups, and compared with BCI (16%) and ROR (33%), assays that, like the RS assay, use three risk groups.Table:


Discordancea Between the RS Assay and Other Assays
Sestak 201637%5%42%
Bartlett 2016c40%10%50%
Alvarado 201537%10%46%
Dowsett 201341%3%43%
Sinn 201745%20%66%
Varga 201329%/29%18%/21%47%/50%
Clough 201338%19%57%
Denduluri 201134%25%58%
Maroun 201531%22%53%
Shivers 201326%19%44%

a. Overall=any discordance in risk classification between the RS assay and other; 1-level=discordance of one risk category (low ↔ intermediate or intermediate ↔ high); 2-level=discordance of two risk categories (low ↔ high). b. Four studies lacked risk classification information appropriate for inclusion in this table. c. Study used nonstandard RS cutoffs for the RS vs. MMP comparison.


The five most common genomic assays in clinical use for EBC risk-stratify pts differently and thus are not interchangeable. Of these, the RS assay classifies the smallest proportion of pts as high risk.

Clinical trial identification


Legal entity responsible for the study

Zsuzsanna Varga


Genomic Health


Z. Varga: Consultant/advisor: Genomic Health, Roche. P. Sinn: Advisor: Genomic Health. D. McCullough, A. Lau, M.C. Stöppler, F.L. Baehner, C. Chao: Employment and stock ownership: Genomic Health. A. Seidman: Consultant/speaker: Genomic Health.

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