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Clinical Utility of Oncotype DX DCIS Test in Breast Cancer: A Population-Based Study

This study explores the utilization and impact of the Oncotype DX DCIS test in breast cancer management using SEER data. It analyzes test utilization trends, risk group distribution, and associations between test results and treatment decisions. The quality assessment of SEER data in capturing test information is also discussed. Findings reveal disparities in test receipt based on demographic and clinical factors, highlighting the importance of accurate data linkage for improving registry completeness.

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Clinical Utility of Oncotype DX DCIS Test in Breast Cancer: A Population-Based Study

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  1. OncotypeDX DCIS test use and clinical utility: A SEER population-based study Yao Yuan, PhD, MPH, Alison Van Dyke, MD, PhD, Serban Negoita, MD, DrPH & Valentina Petkov, MD, MPH NCI SEER SRP 2019 NAACCR/IACR Combined Annual Conference 06/11/2019

  2. Contents Background Cases with linked test: DCIS test utilization Clinical utility SEER data quality assessment: Completeness and accuracy of test data items abstracted by registries

  3. Multigene prognostic tests for Breast Cancer • Oncotype DX • MammaPrint • Prosigna/PAM50 • EndoPredict • Breast Cancer Index • Mammostrat • IHC4

  4. Viera and Schmitt 2018. doi: 10.3389/fmed.2018.00248

  5. Oncotype DX- SEER linkage • Oncotype DX DCIS: 12-gene test • Risk score: 0-100. • Risk groups: low risk ( DCIS score < 39), intermediate risk (DCIS score 39-54) and high risk (DCIS score ≥ 55). • Prediction of 10-year risk of recurrence, and benefit from XRT. • SEER data: • Collected as SSF22 (Method) & 23 (Result). • DCIS breast cancer cases diagnosed between 2011-2015. Picture adapted from Solin et al. 2013

  6. DCIS test utilization

  7. DCIS test utilization Only DCIS histology cases.

  8. DCIS test utilization: Risk group defined by the test* N=146 “Cancelled test” N=129 “Failed test” N=11 “Non-unique” *DCIS histology only

  9. Results I- Summary • DCIS test were performed on non-DCIS histology cases. • The proportion of DCIS patients receiving the test has been increasing since 2011. • Most of the tested cases were in low risk group.

  10. *Only DCIS histology cases were included in the model.

  11. Continued *Only DCIS histology cases were included in the model.

  12. Continued *Only DCIS histology cases were included in the model.

  13. Results II-Summary Patients were less likely to receive the test if they were/had: • ≥ 75 years. • Larger and higher-grade tumors. • Divorced or widowed. • In Medicaid.

  14. Test utility in clinical decisions: Chemotherapy

  15. Test utility in clinical decisions: Radiation

  16. Test utility in clinical decisions: Surgery

  17. Results III-Summary • Patients in higher risk group(s) were more likely to be associated with chemotherapy, radiation or mastectomy surgery, respectively, than in low risk group.

  18. Conclusions for part I: cases with linked test • Clinical adoption of the Oncotype DX DCIS test has been slowly increasing. • The association between multiple demographic factors and receiving the test indicated disparities in the US population. • Clinical factors also influenced whether patients received the test. • Oncotype DX DCIS results were associated with treatment decisions.

  19. SEER data quality assessment

  20. SEER data quality assessment

  21. SEER data quality assessment Cases with valid test scores (0-100) recorded in SEER N=992 Kappa=0.96 Possibly entered in SEER as the % risk of recurrence instead of the score.

  22. SEER data quality assessment: multiple primary tumors Cases (sent as DCIS) deemed as IBC by GHI pathologists and performed the Dx RS test? • Table 9: Tumor numbers for cases not linked to DCIS but linked to RS test (invasive). • Diagnosed as DCIS first, followed by IBC, • OR • Diagnosed as IBC first, followed by DCIS. • RS test date closer to DCIS diagnosis date, thus linked to DCIS tumor. • *Included tested cases with or without results reported. All histology included.

  23. Conclusions for part II: SEER data quality assessment • SEER data items are questionable: • Tests were not captured in the registry data. • Test data were entered incorrectly. • Data linkage is important for the completeness and accuracy of registry data.

  24. Acknowledgement • SEER registries participated in the linkage. • Genomic Health (GHI) provided the data. Thank you! Questions: yao.yuan@nih.gov

  25. SEER data quality assessment Linked to all breast cancer cases Linked to in situ cases

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