Multigene Genomic Testing (ONCOTYPE DX) among New York Prostate Cancer Patients

1. Multigene Genomic Testing (ONCOTYPE DX) among New York Prostate Cancer Patients JovankaN Harrison, Amy R Kahn, Maria J Schymura New York State Cancer Registry NAACCR/IARC Combined Annual Conference, Vancouver, Canada, June 11, 2019

2. Background The ONCOTYPE DX Genomic Prostate Score (GPS) Assay (“The Test”) is a biopsy-based multigene assay suggested for use in localized disease. It is also a (recently) Medicare-approved test for eligible patients.

3. Background Continued 3. Eligibilitywas defined as: Gleason Score (3+3) = 6 (clinically low risk) PSA < 20 PSA < 10 <cT1c-cT2a or <cT2b-cT2c Gleason Score (3+4) = 7 (favorable- intermediate-risk ) PSA < 10 <cT2b-cT2c Note: Adverse pathology = Gleason Score > (4+3) and/or pT3+ (not eligible.)

4. Purpose Assess ONCOTYPE DX Genomic Prostate Score (GPS) Assay use among NY state residents diagnosed between Jan 1, 2015 and Dec 31, 2017. Identify characteristics associated with test use (patient demographics, tumor stage, dx confirmation, type of facility). Describe treatment reported for those who had the test compared with those who did not.

5. Methods 41,698 NY residents with prostate tumors diagnosed between 2015 and 2017 were selected from the NY State Cancer Registry’s (NYSCR) data base (SEER*DMS), seer_site_group=28010. Inclusion criteria, based on ICD-O-3 codes: C61.9 (Prostate gland), behavior=3 (malignant) and histology ranges (8000- 8110, 8140-8576, 8940-8950, 8990-8981). Exclusion criteria: Autopsy cases, death certificate only cases.

6. Methods Continued 2. Patient, tumor, and treatment data from NYSCR were linked to ONCOTYPE DX GPS Assay results submitted to the NYS Dept. of Health’s Electronic Clinical Laboratory Reporting System (ECLRS). 3. For patients who had tumors reported by more than one source - the ‘best source’ record for the tumor was selected based on a combination of type of reporting source (NAACCR #500) together with class of case (NAACCR #610).

7. Results – Distribution of Usage by Dx Yr

8. Results – Distribution of Usage by Age

9. Results – Distribution by Race/Ethnicity NH = Non-Hispanic

10. Results – Distribution by Diagnostic Confirmation

11. Results – Distribution by Stage1at Diagnosis 1 Derived AJCC 7 Stage Group AND Class of Case 10-22 (Analytic). 2 No patients with Stage IV had received the test, so the group was excluded.

12. Results – Distribution by PSA1 1 Prostate Specific Antigen (PSA) lab value is captured in Collaborative Stage (CS) Site Specific Factor (SSF) 1.

13. Results – Distribution by Gleason Score1 1 CSSSF 8.

14. Results – Distribution by Eligibility Status1 1 As previously defined on slide 3.

15. Results – Distribution by Type of Reporting Facility-Commission on Cancer(CoC)1Accredited or Not 1https://www.facs.org/search/cancer-programs 2 Analytic Cases (class of case 10-22), only.

16. Results – Distribution by Overall Treatment1 1 RX_Summ_treatment_status

17. Results Summary- Overall Sample The overall sample included 41,698 prostate cancer patients. Of those, 4.8% had the genomic test analysis. The penetrance was higher for dx years 2016 and 2017 (5.6%) compared with 2015 (3.2%). Men ages 65 and older, especially those 75+ (2.4%) were less likely to get tested, when compared with those aged < 55 (5.9%). Non-Hispanic Black men (3.1%) and Hispanic men (4.4%) were less likely to be tested compared with Non-Hispanic White men (5.4%)

18. Conclusions The use of the ONCOTYPE DX Prostate Genomic Score Assay for Prostate Cancer cases, while only used for approximately 5% of cases, has risen for New York patients since its introduction. It has been used more often for younger patients, for Non-Hispanic White and Non-Hispanic Other (Am Indian, Asian, etc.) patients.

19. Conclusions, cont’d. The use of the genomic test ONCOTYPE DX for Prostate has been consistent with recommendations in terms of Gleason Score and clinical stage. Patients for whom the assay was completed were treated less aggressively than patients for whom the assay was not performed.

20. Next Steps Collaborate on developing the ability to capture the Genomic score for prostate cancers in a standard format on our database. Continue to track adoption of the test to see if, and to what extent, the use continues -- and to see if the currently identified demographic and diagnostic patterns persist.

21. Special Thanks To: Maria J. Schymura, Ph.D. (Director, Bureau of Cancer EPI), Amy R. Kahn, M.S., CTR Todd Szwetkowski, CTR The Analysis and the Output Unit, Entire NYSCR Staff, The NYS DOH Electronic Clinical Laboratory Reporting System Staff

22. Acknowledgements This project has been funded in whole or in part: by the Centers for Disease Control and Prevention’s National Program of Cancer Registries through cooperative agreement 6NU58DP006309 awarded to the New York State Department of Health.  The contents are solely the responsibility of the New York State Department of Health and do not necessarily represent the official views of the Centers for Disease Control and Prevention and with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201800009I