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. 2022 Jul 1;17(3):132.
doi: 10.3892/mco.2022.2565. eCollection 2022 Sep.

Concordance between Ki-67 index in invasive breast cancer and molecular signatures: EndoPredict and MammaPrint

Jesús Eduardo Amezcua-Gálvez  1 , Carlos A Lopez-Garcia  1   2 , Cynthia Villarreal-Garza  3 , Victor Lopez-Rivera  4 , Mauricio Canavati-Marcos  3 , Sandra Santuario-Facio  5 , Antonio Dono  2 , Paloma Del C Monroig-Bosque  6 , Rocío Ortiz-López  5 , Andrea Leal-Lopez  3 , Gabriela Sofía Gómez-Macías  1   7
Affiliations

Concordance between Ki-67 index in invasive breast cancer and molecular signatures: EndoPredict and MammaPrint

Jesús Eduardo Amezcua-Gálvez et al. Mol Clin Oncol. .

Abstract

Identifying patients with hormone receptor-positive (HR+) early invasive breast cancer (EIBC) who benefit from adjuvant chemotherapy has improved with molecular signature tests. However, due to high cost and limited availability, alternative tests are used. The present study sought to evaluate the performance of the proliferation marker Ki-67 to identify these patients and explore its association with molecular signatures and risk stratification markers. From the San José TecSalud Hospital in Monterrey México, patients with HR+ EIBC as tested with EndoPredict or MammaPrint and Ki-67 index were identified. They were categorized into two groups: Group 1 (June 2016-August 2018) was evaluated using EndoPredict and Group 2 (June 2016-August 2018) with MammaPrint. A ≥20% Ki67 index cutoff was utilized to identify highly proliferative EIBC and an area under the receiver-operating characteristic curve and κ concordance were utilized to evaluate the performance of Ki-67 index compared to molecular signature tests. In the EndoPredict group, 54/96 patients were considered high-risk based on their EPclin score, while 57/96 patients had Ki-67 index ≥20%. However, there was no significant overall concordance between them (59.37%, κ=0.168, P=0.09), while the given risk of distant recurrence given in percentage by EPclin had a positive association with the Ki67 index (P=0.04). In the MammaPrint group, 21/70 patients were considered high-risk and 36/70 patients presented with a Ki-67 index ≥20% with a significant overall concordance (67.14%, κ=0.35, P<0.001). In addition, high Ki-67 index was associated with the Nottingham histological grade in both groups. In conclusion, there was a concordance between Ki-67 and MammaPrint risk stratification of HR+ EIBC and no concordance with the EndoPredict molecular signature, but a positive association with the given percentage of recurrence and the median Ki-67 index as the cutoff at our center. Cost-effectiveness analyses of these tests in developing countries are required; until then, the use of Ki-67 appears reasonable to aid clinical decisions, together with the other established clinicopathological variables.

Keywords: EndoPredict; Ki-67; MammaPrint; early breast cancer.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Receiver-operating characteristic curve for the performance of Ki-67 expression in identifying all patients at high risk of recurrence with an area under the curve of 0.6476 (95% CI, 0.5624-0.7328) (P=0.0011). Cutoff value for Ki-67 index, 20%.
Figure 2
Figure 2
Receiver-operating characteristic curve for the performance of Ki-67 expression in identifying patients at high risk of recurrence according to EndoPredict with an area under the curve of 0.5952 (95% CI, 0.4808-0.7096) (P=0.1106). Cutoff value for Ki-67 index, 20%.
Figure 3
Figure 3
Receiver-operating characteristic curve for the performance of Ki-67 expression in identifying patients at high risk of recurrence according to MammaPrint with an area under the curve 0.7259 (95% CI, 0.5872-0.8647) (P=0.0029). Cutoff value for Ki-67 index, 20%.
Figure 4
Figure 4
Forest plot for the Ki-67 expression index in the two groups and all patients. The median (interquartile range) (%) were as follows: EndoPredict: 19.5 (10-30) vs. 25 (10-30), Low vs. High, P=0.1062; MammaPrint: 15 (8-20) vs. 30 (20-35), Low vs. High, P=0.002, all patients: 15 (10-25) vs. 30 (10-35), Low vs. High, P=0.009.
Figure 5
Figure 5
Proportional differences of patients with high and low risk according to MammaPrint and EndoPredict results. The black bars indicate the proportion of the patients with Ki-67 <20% and the gray labels the proportion in patients with Ki-67 ≥20%.
Figure 6
Figure 6
Positive correlation between Ki-67 index and the estimated risk for distant recurrence at 10 years assessed by EPclin in patients with early breast cancer (r2=0.2255, P=0.04).
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