OncotypeDX DCIS test use and clinical utility: A SEER population-based study

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

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