A Prospective Comparison of the 21-Gene Recurrence Score and the PAM50-Based Prosigna in Estrogen Receptor-Positive Early-Stage Breast Cancer
Introduction The 21-gene Recurrence Score ® assay (Onco type DX ® , Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with estrogen receptor-positive (ER+) early-stage breast cancer treated with endocrine therapy. The Prosigna ® assay (NanoString Tech...
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Published in | Advances in therapy Vol. 32; no. 12; pp. 1237 - 1247 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Cheshire
Springer Healthcare
01.12.2015
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Subjects | |
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Abstract | Introduction
The 21-gene Recurrence Score
®
assay (Onco
type
DX
®
, Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with estrogen receptor-positive (ER+) early-stage breast cancer treated with endocrine therapy. The Prosigna
®
assay (NanoString Technologies Inc.) is a validated prognosticator in postmenopausal patients with low-risk ER+ early-stage breast cancer treated with endocrine therapy. The assays were analytically/clinically developed and validated differently. This study focused on comparing recurrence risk estimates as determined by these assays and is the first blinded comparison of these assays on matched patient samples.
Methods
Sequential breast cancer specimens from postmenopausal, node-negative, ER+ patients treated at the Marin General Hospital were analyzed: first by the 21-gene assay then by the Prosigna assay in an independent lab blinded to the Recurrence Score results.
Results
The final analysis included 52 patients. Correlation between the Recurrence Score and the Prosigna assay results was poor (
r
= 0.08). Agreement between risk classifications based on these assays was 54%; 4/7 of patients classified as high risk by the Prosigna assay had low Recurrence Score results. Two tumors with high Recurrence Score results had low ER expression (close to positivity threshold); both of which had a low/intermediate Prosigna assay result. The Prosigna assay classified 73.1% and 23.1% of samples as luminal A and luminal B, respectively. A range of Recurrence Score results was observed within the subtypes; 83% of luminal B samples had a low Recurrence Score result.
Conclusion
Consistent with prior comparisons between the 21-gene and other genomic assays, our study demonstrated substantial differences in the way patients are risk stratified, suggesting that the different assays are not interchangeable.
Funding
Genomic Health, Inc. |
---|---|
AbstractList | INTRODUCTIONThe 21-gene Recurrence Score(®) assay (Oncotype DX(®), Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with estrogen receptor-positive (ER+) early-stage breast cancer treated with endocrine therapy. The Prosigna(®) assay (NanoString Technologies Inc.) is a validated prognosticator in postmenopausal patients with low-risk ER+ early-stage breast cancer treated with endocrine therapy. The assays were analytically/clinically developed and validated differently. This study focused on comparing recurrence risk estimates as determined by these assays and is the first blinded comparison of these assays on matched patient samples.METHODSSequential breast cancer specimens from postmenopausal, node-negative, ER+ patients treated at the Marin General Hospital were analyzed: first by the 21-gene assay then by the Prosigna assay in an independent lab blinded to the Recurrence Score results.RESULTSThe final analysis included 52 patients. Correlation between the Recurrence Score and the Prosigna assay results was poor (r = 0.08). Agreement between risk classifications based on these assays was 54%; 4/7 of patients classified as high risk by the Prosigna assay had low Recurrence Score results. Two tumors with high Recurrence Score results had low ER expression (close to positivity threshold); both of which had a low/intermediate Prosigna assay result. The Prosigna assay classified 73.1% and 23.1% of samples as luminal A and luminal B, respectively. A range of Recurrence Score results was observed within the subtypes; 83% of luminal B samples had a low Recurrence Score result.CONCLUSIONConsistent with prior comparisons between the 21-gene and other genomic assays, our study demonstrated substantial differences in the way patients are risk stratified, suggesting that the different assays are not interchangeable.FUNDINGGenomic Health, Inc. Introduction The 21-gene Recurrence Score ® assay (Onco type DX ® , Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with estrogen receptor-positive (ER+) early-stage breast cancer treated with endocrine therapy. The Prosigna ® assay (NanoString Technologies Inc.) is a validated prognosticator in postmenopausal patients with low-risk ER+ early-stage breast cancer treated with endocrine therapy. The assays were analytically/clinically developed and validated differently. This study focused on comparing recurrence risk estimates as determined by these assays and is the first blinded comparison of these assays on matched patient samples. Methods Sequential breast cancer specimens from postmenopausal, node-negative, ER+ patients treated at the Marin General Hospital were analyzed: first by the 21-gene assay then by the Prosigna assay in an independent lab blinded to the Recurrence Score results. Results The final analysis included 52 patients. Correlation between the Recurrence Score and the Prosigna assay results was poor ( r = 0.08). Agreement between risk classifications based on these assays was 54%; 4/7 of patients classified as high risk by the Prosigna assay had low Recurrence Score results. Two tumors with high Recurrence Score results had low ER expression (close to positivity threshold); both of which had a low/intermediate Prosigna assay result. The Prosigna assay classified 73.1% and 23.1% of samples as luminal A and luminal B, respectively. A range of Recurrence Score results was observed within the subtypes; 83% of luminal B samples had a low Recurrence Score result. Conclusion Consistent with prior comparisons between the 21-gene and other genomic assays, our study demonstrated substantial differences in the way patients are risk stratified, suggesting that the different assays are not interchangeable. Funding Genomic Health, Inc. The 21-gene Recurrence Score(®) assay (Oncotype DX(®), Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with estrogen receptor-positive (ER+) early-stage breast cancer treated with endocrine therapy. The Prosigna(®) assay (NanoString Technologies Inc.) is a validated prognosticator in postmenopausal patients with low-risk ER+ early-stage breast cancer treated with endocrine therapy. The assays were analytically/clinically developed and validated differently. This study focused on comparing recurrence risk estimates as determined by these assays and is the first blinded comparison of these assays on matched patient samples. Sequential breast cancer specimens from postmenopausal, node-negative, ER+ patients treated at the Marin General Hospital were analyzed: first by the 21-gene assay then by the Prosigna assay in an independent lab blinded to the Recurrence Score results. The final analysis included 52 patients. Correlation between the Recurrence Score and the Prosigna assay results was poor (r = 0.08). Agreement between risk classifications based on these assays was 54%; 4/7 of patients classified as high risk by the Prosigna assay had low Recurrence Score results. Two tumors with high Recurrence Score results had low ER expression (close to positivity threshold); both of which had a low/intermediate Prosigna assay result. The Prosigna assay classified 73.1% and 23.1% of samples as luminal A and luminal B, respectively. A range of Recurrence Score results was observed within the subtypes; 83% of luminal B samples had a low Recurrence Score result. Consistent with prior comparisons between the 21-gene and other genomic assays, our study demonstrated substantial differences in the way patients are risk stratified, suggesting that the different assays are not interchangeable. Genomic Health, Inc. |
Author | Cherbavaz, Diana B. Markopoulos, Christos J. Prasad, Che Baehner, Frederick L. Svedman, Christer Alvarado, Michael D. Sing, Amy P. Rothney, Megan |
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Cites_doi | 10.1056/NEJMoa1510764 10.1093/annonc/mdt494 10.1200/JCO.2005.04.7985 10.1056/NEJMoa041588 10.1038/35021093 10.1186/bcr1412 10.1093/annonc/mds645 10.2353/jmoldx.2008.070153 10.1093/annonc/mdt303 10.1200/JCO.2012.46.1558 10.1200/JCO.2009.24.4798 10.1073/pnas.191367098 10.1016/S1470-2045(09)70314-6 10.1371/journal.pone.0058483 10.1002/cncr.25206 10.1200/JCO.2007.14.2364 10.1200/jco.2011.29.27_suppl.13 10.1093/annonc/mdt284 10.1200/jco.2014.32.15_suppl.11024 10.1200/jco.2013.31.15_suppl.506 10.1158/0008-5472.SABCS13-P6-06-02 |
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Keywords | PAM50 Adjuvant chemotherapy DX Recurrence Score Oncology Breast cancer Prosigna, risk assessment Onco Oncotype DX |
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Snippet | Introduction
The 21-gene Recurrence Score
®
assay (Onco
type
DX
®
, Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in... The 21-gene Recurrence Score(®) assay (Oncotype DX(®), Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in patients with... INTRODUCTIONThe 21-gene Recurrence Score(®) assay (Oncotype DX(®), Genomic Health, Inc.) is a validated predictor of recurrence risk/chemotherapy benefit in... |
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SubjectTerms | Aged Breast Neoplasms - genetics Breast Neoplasms - pathology Cardiology Endocrinology Female Gene Expression Profiling Humans Internal Medicine Medicine Medicine & Public Health Middle Aged Neoplasm Recurrence, Local - genetics Neoplasm Recurrence, Local - pathology Oncology Original Research Pharmacology/Toxicology Prospective Studies Receptors, Estrogen - metabolism Rheumatology Risk Assessment |
Title | A Prospective Comparison of the 21-Gene Recurrence Score and the PAM50-Based Prosigna in Estrogen Receptor-Positive Early-Stage Breast Cancer |
URI | https://link.springer.com/article/10.1007/s12325-015-0269-2 https://www.ncbi.nlm.nih.gov/pubmed/26610383 https://search.proquest.com/docview/1750003111 https://pubmed.ncbi.nlm.nih.gov/PMC4679783 |
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