1. Multigene Genomic Testing (ONCOTYPE DX)
among New York Prostate Cancer Patients
Jovanka N Harrison, Amy R Kahn, Maria J Schymura
New York State Cancer Registry
NAACCR/IARC Combined Annual Conference, Vancouver, Canada, June 11, 2019
1. Good Afternoon! We are excited to share with you our first look at the genomic data reported to the New York State Cancer Registry. By “we” I am also referring to my dear colleagues and friends, present here, Dr. Maria Schymura, Director, of the Bureau of Cancer Epidemiology and the New York State Cancer Registry, and Ms. Amy Kahn, Research Scientist, CTR, and invaluable expert advisor to us all. I am thankful for their vision and continued guidance that has led us to this moment. I would also like to thank the previous presenter for setting the stage, and introducing you to the Oncotype DX assays. Nine years ago, when we first started working with Genomic Health, we were not sure that we would be able to persuade them to start reporting to us. By November 2011, we had them on board. The first pathology reports that we received were for breast cancer, followed by colon cancer a few years later, and then, in 2013 the ONCOTYPE DX GENOMIC PROSTATE SCORE (GPS) Assay results started arriving.

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.
2. 1) Oncotype DX prostate cancer assay is optimized for prostate needle biopsies. It measures EXPRESSION of 12 prostate cancer-related genes and 5 reference genes to GENERATE the Genomic Prostate Score (GPS). The GPS result range is from 0-100, where the scores correspond to the biologic aggressiveness of the tumor. The lower the score, the lower the risk. 2) In order for the test TO BE PAID BY MEDICARE, a patient HAD TO MEET SPECIFIC ELIGIBILITY CRITERIA.

3. Background Continued 3. Eligibility was defined as :
Gleason Score (3+3) = (clinically low risk)
PSA < PSA < 10
<cT1c-cT2a or <cT2b-cT2c
Gleason Score (3+4) = (favorable- intermediate-risk )
PSA < 10
<cT2b-cT2c
Note: Adverse pathology = Gleason Score > (4+3) and/or pT3+ (not eligible.)
3. “The Test” is recommended for men who have: 1) Had a prostate biopsy within the last three years, 2) NOT started definitive treatment (e.g. surgery or radiation).
Clinically low- and favorable-intermediate-risk prostate cancer—meeting the criteria for National Comprehensive Cancer Network (NCCN) VERY -LOW, LOW, or INTERMEDIATE-risk disease. Patients with adverse pathology did not meet the eligibility criteria for Medicare to pay for the test.

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.
Look at Test Use (Oncotyple Dx Genomic Prostate Score Assay among NY state residents diagnosed between 2015 and 2017.
Identify characteristics associated with Test use: patient demographics, tumor stage, dx conf, and type of facility.
Describe treatment 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 ( , , , ).
Exclusion criteria: Autopsy cases, death certificate only cases.
We selected NY residents diagnosed with malignant prostate cancer between Jan 1, 2015 and Dec. 31, Patients we selected from the NYSCR data base (on SEER*DMS), and with the seer_site_group=28010.
Shown are the histology ranges included. Autopsy cases and DCOs were excluded from the analyses.

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
Prostate Cancer Cases by Diagnosis Year and Oncotype DX Test Use, NY State
DX Year
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
2015
13, (32.9)
13,265 (96.8)
(3.2)
2016
14, (33.9)
13,372 (94.4)
(5.6)
2017
13, (33.2)
13,044 (94.4)
(5.6)
Total
41, (100)
39,681 (95.2)
2,017 (4.8)
THE OVERALL (AVERAGE TEST USE) for the 3 year period was 5%.
The penetrance of test use increased from 3.2% in 2015 to to 5.6%.

8. Results – Distribution of Usage by Age
Prostate Oncotype DX Test Use by Age Group, NY State
Age Group
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
< 55 yrs
3,512 (8.4)
3,304 (94.1)
(5.9)
55-64
15,653 (37.5)
14,787 (94.5)
866 (5.5)
65-75
15,883 (38.1)
15,101 (95.1)
782 (4.9)
75 +
6,650 (16.0)
6,489 (97.6)
161 (2.4)
Total
41,698 (100)
39,681 (95.2)
2,017 (4.8)
Patients 55 years of age and younger were more likely to have had the test.

9. Results – Distribution by Race/Ethnicity
Prostate Oncotype DX Test Use by Race/Ethnic Group, NY State
Race/Ethnic Group
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
White NH
27,257 (65.4)
25,790 (94.6)
1,467 (5.4)
Black NH
8,058 (19.3)
7,812 (96.9)
246 (3.1)
Other NH
2,395 (5.7)
2,262 (94.5)
133 (5.6)
Hispanic
3,988 (9.6)
3,817 (95.7)
171 (4.4)
Total
41,698 (100)
39,681 (95.2)
2,017 (4.8)
NH = Non-Hispanic

10. Results – Distribution by Diagnostic Confirmation
DX Confirmation by Prostate Oncotype DX Test Use, NY State
Diagnostic Confirmation
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
Positive Histology
40,866 (99.5)
38, (95.1)
(4.9)
Positive Cytology
(0.5)
(97.2)
6 (2.8)
Total
41,080 (100)
39,063 (95.1)
2, (4.9)
99.5% of prostate cancer patients had dx confirmation through a positive histology (tissue microscopically examined) - of those, only 5% also had a the genomic test.
2. Positive cytology (fluid cells microscopically examined, e.g., prostatic secretions).

11. Results – Distribution by Stage1 at Diagnosis
Prostate Oncotype DX Test Use by Stage Group
Stage Group
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%) I
1,443 (20.9)
1,364 (94.5)
(5.5)
IIA
1,755 (25.4)
1,720 (98.0)
(2.0)
IIB
2,679 (38.7)
2,643 (98.7)
(1.3)
III
1,039 (15.0)
1,030 (99.1)
(0.9)
Total
6,916 (100)
6,757 (97.7)
(2.3)
NOTE: Derived AJCC 7 Stage Group was only available for 2015 cases. (Stage IV N=1, none of stage IV patients had the Oncotype DX Test.
1 Derived AJCC 7 Stage Group AND Class of Case (Analytic).
2 No patients with Stage IV had received the test, so the group was excluded.

12. Results – Distribution by PSA1
Oncotype DX Test Use by PSA, NY State
PSA
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
< 10.0 ng/m
14,264 (67.2)
13,558 (95.0)
(5.0)
ng/ml
3,363 (15.9)
3,276 (97.4)
(2.6)
ng/ml
2,286 (10.8)
2,268 (99.2)
(0.8)
98.0 ng/ml or >
1,303 ( 6.1)
1,303 (100)
( . )
Total
21,216 (100)
20,405 (96.2)
(3.8)
Unit of Measure: ng/ml = nanograms od PSA per milliliter of blood. The highest PSA lab value documented in the medical record prior to diagnostic biopsy of prostate and treatment is recorded by the cancer registry. PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. Benign prostate conditions that cause an elevation in PSA level are prostatitis (inflammation of the prostate) and benign prostatic hyperplasia (BPH) (enlargement of the prostate).
1 Prostate Specific Antigen (PSA) lab value is captured in Collaborative Stage (CS) Site Specific Factor (SSF) 1.

13. Results – Distribution by Gleason Score1
Oncotype DX Test Use by Gleason Pattern/Score, NY State
Gleason Score
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
< = 5
51 ( 0.2)
50 (98.0)
1 (2.0) 6
6,173 (27.7)
5,635 (91.3)
(8.7) 7
10,384 (46.6)
10,062 (96.9)
322 (3.1)
8 - 10
5,609 (25.5)
5,688 (99.96)
2 (0.04)
Total
22,298 (100)
20,405 (96.2)
811 (3.8)
CS SSF8 = Gleason Score based on Needle Core biopsy/ (TURP) Transurethral Resection of Prostate.
1 CS SSF 8.

14. Results – Distribution by Eligibility Status1
Oncotype DX Test Use by Eligibility Status
Eligibility Status
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
Elig. GS 6
7,358 (17.7)
6,526 (88.7)
832 (11.3)
Elig. GS 7
5,981 (14.3)
5,626 (94.1)
355 (5.9)
Not Elig. GS 6/7+
15,014 (36.0)
14,284 (95.1)
730 (4.9)
Not/adverse path.
13,345 (32.0)
13,245 (99.3)
100 (0.7)
Total
41,698 (100)
39,681 (95.2)
2,017 (4.8)
1 As previously defined on slide 3.

15. Type of Reporting Facility by Prostate Oncotype DX Test Use2
Results – Distribution by Type of Reporting Facility- Commission on Cancer(CoC)1 Accredited or Not
Type of Reporting Facility by Prostate Oncotype DX Test Use2
CoC
n (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
Not
6,971 (28.6)
6, (97.3)
(2.7)
Yes
17,404 (71.4)
16,723 (96.1)
(3.9)
Total
24,375 (100)
23,503 (96.4)
(3.6) 1
2 Analytic Cases (class of case 10-22), only.

16. Results – Distribution by Overall Treatment1
Overall Treatment Status by Prostate Oncotype DX Test Use
Treatment Status
N (%)
Test Use:
“No” (%)
Test Use:
“Yes” (%)
No tx given
5,278 (12.7)
4,781 (90.6)
497 (9.4)
Tx given
30,556 (73.3)
29,804 (97.5)
752 (2.5)
Active surv.
4,641 (11.1)
3,989 (86.0)
652 (14.0)
Unknown
1,223 (2.9)
1,107 (90.5)
116 (9.5)
Total
41,698 (100)
39,681 (95.2)
2,017 (4.8)
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 6NU58DP 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. HHSN I