Research Papers:

Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer

Aranzazu Fernandez-Martinez, Tomás Pascual, Giuseppe Perrone, Serafin Morales, Juan de la Haba, Milagros González-Rivera, Patricia Galvan, Francesca Zalfa, Michaela Amato, Lucia Gonzalez, Miquel Prats, Federico Rojo, Luis Manso, Laia Paré, Immaculada Alonso, Joan Albanell, Ana Vivancos, Antonio González, Judit Matito, Sonia González, Pedro Fernandez, Barbara Adamo, Montserrat Muñoz, Margarita Viladot, Carme Font, Francisco Aya, Maria Vidal, Rosalía Caballero, Eva Carrasco, Vittorio Altomare, Giuseppe Tonini, Aleix Prat and Miguel Martin _

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Oncotarget. 2017; 8:21930-21937. https://doi.org/10.18632/oncotarget.15748

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Aranzazu Fernandez-Martinez1,2, Tomás Pascual1,2, Giuseppe Perrone3, Serafin Morales4, Juan de la Haba5, Milagros González-Rivera6, Patricia Galván1,2,7, Francesca Zalfa3, Michela Amato3, Lucia Gonzalez8, Miquel Prats9, Federico Rojo10, Luis Manso11, Laia Paré1,2, Immaculada Alonso1, Joan Albanell12, Ana Vivancos7, Antonio González13, Judit Matito7, Sonia González14, Pedro Fernandez1, Barbara Adamo1,2, Montserrat Muñoz1,2, Margarita Viladot1,2, Carme Font1,2, Francisco Aya1,2, Maria Vidal1,2, Rosalía Caballero15, Eva Carrasco15, Vittorio Altomare3, Giuseppe Tonini3, Aleix Prat1,2,7, Miguel Martin6

1Medical Oncology Department, Hospital Clínic of Barcelona, Barcelona, Spain

2Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain

3Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy

4Medical Oncology Deparment, Arnau de Vilanova de Lleida Universitary Hospital, Lleida, Spain

5Medical Oncology Department, Reina Sofía University Hospital, Cordoba, Spain

6Medical Oncology Department, Instituto de Investigación Sanitaria Gregorio Marañón (IISGM), Universidad Complutense, Madrid, Spain

7Vall d'Hebron Institute of Oncology, Barcelona, Spain

8Medical Oncology Department, Quirón Hospital, Madrid, Spain

9Master of Breast Pathology, University of Barcelona, Barcelona, Spain

10Pathology Department, Fundación Jiménez Díaz Health Research Institute (IIS-FJD), Madrid, Spain

11Medical Oncology Department, Doce de Octubre Hospital, Madrid, Spain

12Medical Oncology Department, Hospital del Mar, Barcelona, Spain

13Medical Oncology Department, MD Anderson Cancer Center, Madrid, Spain

14Medical Oncology Department, Mutua de Terrassa Hospital, Barcelona, Spain

15Spanish Breast Cancer Research Group Grupo Español de Investigación en Cáncer de Mama (GEICAM), Madrid, Spain

Correspondence to:

Miguel Martin, email: [email protected]

Aleix Prat, email: [email protected]

Keywords: PAM50/Prosigna, breast cancer, Ki67, estrogen receptor-positive/HER2-negative

Received: October 19, 2016    Accepted: January 27, 2017    Published: February 27, 2017


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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