%0 Journal Article %A Fernandez-Martinez, Aranzazu %A Pascual, Tomás %A Perrone, Giuseppe %A Morales, Serafin %A de la Haba, Juan %A González-Rivera, Milagros %A Galván, Patricia %A Zalfa, Francesca %A Amato, Michela %A Gonzalez, Lucia %A Prats, Miquel %A Rojo, Federico %A Manso, Luis %A Paré, Laia %A Alonso, Immaculada %A Albanell, Joan %A Vivancos, Ana %A González, Antonio %A Matito, Judit %A González, Sonia %A Fernandez, Pedro %A Adamo, Barbara %A Muñoz, Montserrat %A Viladot, Margarita %A Font, Carme %A Aya, Francisco %A Vidal, Maria %A Caballero, Rosalía %A Carrasco, Eva %A Altomare, Vittorio %A Tonini, Giuseppe %A Prat, Aleix %A Martin, Miguel %T Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer. %D 2017 %U https://hdl.handle.net/10668/25130 %X 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%. %K Ki67 %K PAM50/Prosigna %K breast cancer %K estrogen receptor-positive/HER2-negative %~