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Clinical utility of genomic recurrence risk stratification in early, hormone-receptor-positive, human epidermal growth factor receptor 2-negative breast cancer: Real-World Experience.

Published:November 22, 2022DOI:https://doi.org/10.1016/j.clbc.2022.11.005

      Abstract

      Microabstract

      : This study aimed to compare clinical risk and genomic risk assessment methods in estimating the risk of recurrence in patients with early stage hormone-receptor positive (HR+)/Human Epidermal Growth Factor 2-negative (ERBB2-) breast cancer following surgical resection, in order to estimate adjuvant chemotherapy benefit. Comparing both methods in a sample of 501 patients with early stage disease, there was statistically significant concordance between the different prognostication methods. However in patients with established low clinical risk and those with grade 1 histology, <10% and <5% of patients had a high genomic risk of recurrence, respectively. Further studies are needed to delineate clinical utility, or lack thereof, for routine testing in patients with low grade/low clinical risk of recurrence.

      Background

      : RNA-based genomic risk assessment estimates chemotherapy benefit in patients with hormone-receptor positive (HR+)/Human Epidermal Growth Factor 2-negative (ERBB2-) breast cancer (BC). It is virtually used in all patients with early HR+/ERBB2- BC regardless of clinical recurrence risk.

      Patients and methods

      : We conducted a retrospective chart review of adult patients with early-stage (T1-3; N0; M0) HR+/ERBB2- BC who underwent genomic testing using the Oncotype DX ® (Exact Sciences) 21-genes assay. Clinicopathologic features were collected to assess the clinical recurrence risk, in terms of clinical risk score (CRS) and using a composite risk score of distant recurrence (Regan Risk Score). CRS and RRS were compared to the genomic risk of recurrence (GRS).

      Results

      : Between January 2015 and December 2020, 517 patients with early-stage disease underwent genomic testing, and clinical data was available for 501 of them. There was statistically significant concordance between the 3 prognostication methods (P < 0.01). Within patients with low CRS (n=349), 9.17% had a high GRS, compared to 8.93% in patients with low RRS (n=280). In patients with grade 1 histology (n=130), 3.85% had a high GRS and 68.46% had tumors > 1cm, of whom only 4.49% had a high GRS. Tumor size > 1cm did not associate with a high GRS.

      Conclusion

      : Genomic testing for patients with grade 1 tumors may be safely omitted, irrespective of size. Our finds call for a better understanding of the need for routine genomic testing in patients with low grade/low clinical risk of recurrence.

      Keywords

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