Prediction of Distant Recurrence Using EndoPredict Among Women with ER-positive, HER2-negative Breast Cancer with a Maximum Follow-up of 16 Years

M. Filipits1, P. Dubsky1,2, M. Rudas1, R. Greil3, M. Balic4, F. Fitzal1, Z. Bago-Horvath5, C. Singer6, D. Hlauschek7, R. Kronenwett8, R. Bernhisel9, J. Lancaster9, M. Gnant1

1 Department of Medicine I, Comprehensive Cancer Center, Institute of Cancer Research, Medical University of Vienna, Vienna, AT; 2 Klinik St. Anna, Breast Center, Luzern, CH; 3 III Medical Department, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Paracelsus Medical University Salzburg, Salzburg, AT; 4 Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, AT; 5 Department of Pathology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, AT; 6 Department of Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, AT; 7 Clinical Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, AT; 8 Myriad International GmbH, Cologne, Germany; 9 Myriad Genetics, Inc., Salt Lake City, US

 
 

Summary

  • EndoPredict is the only prognostic test that provides recurrence risk out to 15 years to help guide extended endocrine treatment decisions.
  • EndoPredict low-risk patients had a consistent 4% risk of recurrence in years 5-15.
  • Patients with a lower EndoPredict risk of recurrence in years 5-15 are unlikely to benefit from extended endocrine therapy.

Background

  • Treatment decisions for women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer are made at two time points: at diagnosis for adjuvant chemotherapy and at 5 years post-diagnosis for extended endocrine therapy.
  • EndoPredict has been extensively validated in over 3,500 women with ER positive, HER2 negative disease.1-6
  • Here, we further evaluate the prognostic value of EndoPredict in the combined ABCSG-6 and -8 cohort with longer-term follow-up and compare 10-year distant recurrence (DR) and 5-15 years late recurrence according to nodal status.

Methods

  • Late recurrence risk validated in over 1,700 ER+, HER2- patients.
    • This analysis included 1702 patients with ER-positive, HER2-negative disease who received endocrine therapy only  (n=1166 N0; n=453 N1-3; n=83 N≥4; Table 1).
  • All women received 5 years of adjuvant endocrine therapy alone (no chemotherapy).
  • Analyses were performed for the overall cohort, by nodal status, and for patients who were distant recurrence free at year 5 (late recurrence).

Results

  • For patients who had not recurred by 5 years post-diagnosis (N=1,386), EPclin was also highly prognostic 5-15 years post-diagnosis after adjusting for clinical variables, independent from nodal status.
  • Women with low EPclin had better long-term outcomes than EPclin high-risk patients (HR 4.52, 95% CI 2.65-7.72; p<0.0001).
  • The low-risk group had a distant recurrence-free survival (DRFS) of 95.7% (95% CI, 93.4%, 98.1%) during years 5-15 post-diagnosis, while the high-risk group had a DRFS of 84.1% (95% CI, 78.9%, 89.6%) over this period (Figure 2).

Conclusions

  • Here we show that EPclin successfully predicts risk of early (0-10 years) and late (5-15 years) recurrence for patients with both node-negative and node-positive disease.
  • This analysis of longer follow-up on previously published cohorts1-4 confirms that EPclin can identify a large group of patients at low risk of distant recurrence after 10 years who may be adequately treated with only 5 years of adjuvant endocrine therapy.
  • Replication of these results for the distant recurrence period (5-15 years) indicates that EPclin scores are also informative for selecting patients who may safely forgo extended endocrine therapy.

References

1. Filipits et. al. Clin Cancer Res 2011;17(18): 6012-20 2. Dubsky et. al. Br J Cancer 2013;109(12): 2959-64 3. Dubsky et. al. Ann Oncol 2013;24(3): 640-7 4. Fitzal et.al. Br J Cancer 2015;112(8): 1405-10 5. Buus et.al. J Natl Cancer Inst. 2016;108(11) 6. Sestak et.al. JAMA Oncol. 2018;4(4):545-553

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