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  • Title: Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer.
    Author: Fernandez-Martinez A, Pascual T, Perrone G, Morales S, de la Haba J, González-Rivera M, Galván P, Zalfa F, Amato M, Gonzalez L, Prats M, Rojo F, Manso L, Paré L, Alonso I, Albanell J, Vivancos A, González A, Matito J, González S, Fernandez P, Adamo B, Muñoz M, Viladot M, Font C, Aya F, Vidal M, Caballero R, Carrasco E, Altomare V, Tonini G, Prat A, Martin M.
    Journal: Oncotarget; 2017 Mar 28; 8(13):21930-21937. PubMed ID: 28423537.
    Abstract:
    PAM50/Prosigna gene expression-based assay identifies three categorical risk of relapse groups (ROR-low, ROR-intermediate and ROR-high) in post-menopausal patients with estrogen receptor estrogen receptor-positive (ER+)/ HER2-negative (HER2-) early breast cancer. Low risk patients might not need adjuvant chemotherapy since their risk of distant relapse at 10-years is below 10% with endocrine therapy only. In this study, 517 consecutive patients with ER+/HER2- and node-negative disease were evaluated for Ki67 and Prosigna. Most of Luminal A tumors (65.6%) and ROR-low tumors (70.9%) had low Ki67 values (0-10%); however, the percentage of patients with ROR-medium or ROR-high disease within the Ki67 0-10% group was 42.7% (with tumor sizes ≤2 cm) and 33.9% (with tumor sizes > 2 cm). Finally, we found that the optimal Ki67 cutoff for identifying Luminal A or ROR-low tumors was 14%. Ki67 as a surrogate biomarker in identifying Prosigna low-risk outcome patients or Luminal A disease in the clinical setting is unreliable. In the absence of a well-validated prognostic gene expression-based assay, the optimal Ki67 cutoff for identifying low-risk outcome patients or Luminal A disease remains at 14%.
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