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Prospective Validation of a 21-Gene Expression Assay in Breast Cancer

 J.A. Sparano  ;  R.J. Gray  ;  D.F. Makower  ;  K.I. Pritchard  ;  K.S. Albain  ;  D.F. Hayes  ;  C.E. Geyer Jr.  ;  E.C. Dees  ;  E.A. Perez  ;  J.A. Olson Jr.  ;  J.A. Zujewski  ;  T. Lively  ;  S.S. Badve  ;  T.J. Saphner  ;  L.I. Wagner  ;  T.J. Whelan  ;  M.J. Ellis  ;  S. Paik  ;  W.C. Wood  ;  P. Ravdin  ;  M.M. Keane  ;  H.L. Gomez Moreno  ;  P.S. Reddy  ;  T.F. Goggins  ;  I.A. Mayer  ;  A.M. Brufsky  ;  D.L. Toppmeyer  ;  V.G. Kaklamani  ;  J.N. Atkins  ;  J.L. Berenberg  ;  G.W. Sledge 
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.373(21) : 2005-2014, 2015 
Journal Title
Issue Date
Adult ; Age Factors ; Aged ; Antineoplastic Agents, Hormonal/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/genetics* ; Breast Neoplasms/surgery ; Chemotherapy, Adjuvant ; Female ; Gene Expression ; Gene Expression Profiling ; Humans ; Kaplan-Meier Estimate ; Mastectomy ; Middle Aged ; Multivariate Analysis ; Neoplasm Grading ; Neoplasm Recurrence, Local/epidemiology ; Neoplasm Recurrence, Local/prevention & control* ; Prospective Studies ; Receptor, ErbB-2 ; Receptors, Estrogen ; Receptors, Progesterone ; Reverse Transcriptase Polymerase Chain Reaction ; Survival Analysis
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.).
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Yonsei Authors
Paik, Soon Myung(백순명) ORCID logo https://orcid.org/0000-0001-9688-6480
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