RT Journal Article T1 Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer. A1 Fernandez-Martinez, Aranzazu A1 Pascual, Tomás A1 Perrone, Giuseppe A1 Morales, Serafin A1 de la Haba, Juan A1 González-Rivera, Milagros A1 Galván, Patricia A1 Zalfa, Francesca A1 Amato, Michela A1 Gonzalez, Lucia A1 Prats, Miquel A1 Rojo, Federico A1 Manso, Luis A1 Paré, Laia A1 Alonso, Immaculada A1 Albanell, Joan A1 Vivancos, Ana A1 González, Antonio A1 Matito, Judit A1 González, Sonia A1 Fernandez, Pedro A1 Adamo, Barbara A1 Muñoz, Montserrat A1 Viladot, Margarita A1 Font, Carme A1 Aya, Francisco A1 Vidal, Maria A1 Caballero, Rosalía A1 Carrasco, Eva A1 Altomare, Vittorio A1 Tonini, Giuseppe A1 Prat, Aleix A1 Martin, Miguel K1 Ki67 K1 PAM50/Prosigna K1 breast cancer K1 estrogen receptor-positive/HER2-negative AB 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%. YR 2017 FD 2017 LK https://hdl.handle.net/10668/25130 UL https://hdl.handle.net/10668/25130 LA en DS RISalud RD Apr 6, 2025