Prospective Validation of a 21-Gene Expression Assay in Breast Cancer
By J. Sparano, R. Gray, D. Makower, K. Pritchard, K. Albain, D. Hayes, C. Geyer, E. Dees, E. Perez, J. Olson and 21 more. New England Journal of Medicine, 2015
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BACKGROUND Prior studies with the use of a prospective–retrospective design including archival tumor samples have shown that gene-expression assays provide clinically useful prognostic information. However, a prospectively conducted study in a uniformly treated population provides the highest level of evidence supporting the clinical validity and usefulness of a biomarker. METHODS We performed a prospective trial involving women with hormone-receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative, axillary node–negative breast cancer with tumors of 1.1 to 5.0 cm in the greatest dimension (or 0.6 to 1.0 cm in the greatest dimension and intermediate or high tumor grade) who met established guidelines for the consideration of adjuvant chemotherapy on the basis of clinicopathologic features. A reverse-transcriptase–polymerase-chain-reaction assay of 21 genes was performed on the paraffin-embedded tumor tissue, and the results were used to calculate a score indicating the risk of breast-cancer recurrence; patients were assigned to receive endocrine therapy without chemotherapy if they had a recurrence score of 0 to 10, indicating a very low risk of recurrence (on a scale of 0 to 100, with higher scores indicating a greater risk of recurrence). RESULTS Of the 10,253 eligible women enrolled, 1626 women (15.9%) who had a recurrence score of 0 to 10 were assigned to receive endocrine therapy alone without chemotherapy. At 5 years, in this patient population, the rate of invasive disease–free survival was 93.8% (95% confidence interval [CI], 92.4 to 94.9), the rate of freedom from recurrence of breast cancer at a distant site was 99.3% (95% CI, 98.7 to 99.6), the rate of freedom from recurrence of breast cancer at a distant or local–regional site was 98.7% (95% CI, 97.9 to 99.2), and the rate of overall survival was 98.0% (95% CI, 97.1 to 98.6). CONCLUSIONS Among patients with hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer who met established guidelines for the recommendation of adjuvant chemotherapy on the basis of clinicopathologic features, those with tumors that had a favorable gene-expression profile had very low rates of recurrence at 5 years with endocrine therapy alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.)
Subfields: Cancer Research, Oncology, Pathology and Forensic Medicine
View Paper: https://www.semanticscholar.org/paper/678b0b8b32ca961a251e83845bdd7699e4be7be1
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Citations in the corpus
- Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. (2016, background): “Multimarker analyses that incorporate individual markers into marker panels have been embraced in recent studies,(19,31-33) such as in the 21-gene assay that was identified and validated to spare the use of chemotherapy in certain groups of patients who have breast cancer.(32,33) Similarly, the radi”
- De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 (2018, background): “Gene expression profiling for early-stage breast cancer: prospective studies In the MINDACT trial, a 70-gene signature paired with clinical risk criteria identified patients with breast cancer who did not derive substantial benefit from adjuvant chemotherapy [23].”
- Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. (2020, methodology): “Some panel-based gene-expression assays, like Oncotype DX (Genomic Health, Redwood City, CA), have already been incorporated into standard treatment algorithms for IHC ER-positive cancers as a tool to assess the likelihood of clinical benefit offered by chemotherapy when added to endocrine therapy.(”
- Breast Cancer Treatment: A Review (2019, background): “Score categoryb Low (≤10) Intermediate (11-25) Intermediate (11-25) High (≥26) Low (≤11) Lowintermediate (≤25) High (≥26) Clinical high risk/ MammaPrint low risk Clinical high risk/ MammaPrint low risk”