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

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Background
1. The ONCOTYPE DX Genomic Prostate Score
(GPS) Assay (“The Test”) is a biopsy-based
multigene assay suggested for use in localized
disease.
2. It is also a (recently) Medicare-approved test for
eligible patients.
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Background Continued
3. Eligibility was 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.)
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Purpose
1. Assess ONCOTYPE DX Genomic Prostate Score
(GPS) Assay use among NY state residents
diagnosed between Jan 1, 2015 and Dec 31, 2017.
2. Identify characteristics associated with test use
(patient demographics, tumor stage, dx confirmation,
type of facility).
3. Describe treatment reported for those who had the
test compared with those who did not.
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Methods
1. 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.
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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).
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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: Test Use:

“No” (%) “Yes” (%)
2015 13,704 (32.9) 13,265 (96.8) 439 (3.2)
2016 14,171 (33.9) 13,372 (94.4) 799 (5.6)
2017 13,823 (33.2) 13,044 (94.4) 779 (5.6)
Total 41,698 (100) 39,681 (95.2) 2,017 (4.8)
 
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Results – Distribution of Usage by Age

Prostate Oncotype DX Test Use by Age Group, NY State
Age Group n (%) Test Use: Test Use:
“No” (%) “Yes” (%)
< 55 yrs 3,512 (8.4) 3,304 (94.1) 208 (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)

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Results – Distribution by Race/Ethnicity

Prostate Oncotype DX Test Use by Race/Ethnic Group, NY State
Race/Ethnic n (%) Test Use: Test Use:
Group “No” (%) “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
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Results – Distribution by Diagnostic Confirmation

DX Confirmation by Prostate Oncotype DX Test Use, NY State
Diagnostic n (%) Test Use: Test Use:
Confirmation “No” (%) “Yes” (%)

Positive 40,866 (99.5) 38,855 (95.1) 2011 (4.9)

Histology

Positive 214 (0.5) 208 (97.2) 6 (2.8)

Cytology

Total 41,080 (100) 39,063 (95.1) 2,017 (4.9)

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Results – Distribution by Stage at Diagnosis 1

Prostate Oncotype DX Test Use by Stage Group
Stage n (%) Test Use: Test Use:
Group “No” (%) “Yes” (%)
I 1,443 (20.9) 1,364 (94.5) 79 (5.5)
IIA 1,755 (25.4) 1,720 (98.0) 35 (2.0)
IIB 2,679 (38.7) 2,643 (98.7) 36 (1.3)
III 1,039 (15.0) 1,030 (99.1) 9 (0.9)
 

Total 6,916 (100) 6,757 (97.7) 159 (2.3)

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.
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Results – Distribution by PSA 1

Oncotype DX Test Use by PSA, NY State
PSA n (%) Test Use: Test Use:
“No” (%) “Yes” (%)
14,264 (67.2) 13,558 (95.0) 706 (5.0)
< 10.0 ng/m

3,363 (15.9) 3,276 (97.4) 87 (2.6)

10.0 -19.0 ng/ml

2,286 (10.8) 2,268 (99.2) 18 (0.8)

20.0 -97.9 ng/ml

1,303 ( 6.1) 1,303 (100) - ( . )

98.0 ng/ml or >
 

Total 21,216 (100) 20,405 (96.2) 811 (3.8)

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

Oncotype DX Test Use by Gleason Pattern/Score, NY State
Gleason n (%) Test Use: Test Use:
Score “No” (%) “Yes” (%)
51 ( 0.2) 50 (98.0) 1 (2.0)
<= 5
6,173 (27.7) 5,635 (91.3) 538 (8.7)
6
10,384 (46.6) 10,062 (96.9) 322 (3.1)
7
5,609 (25.5) 5,688 (99.96) 2 (0.04)
8 - 10
 

Total 22,298 (100) 20,405 (96.2) 811 (3.8)

1
CS SSF 8.
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Results – Distribution by Eligibility Status 1

Oncotype DX Test Use by Eligibility Status
Eligibility n (%) Test Use: Test Use:
Status “No” (%) “Yes” (%)
7,358 (17.7) 6,526 (88.7) 832 (11.3)
Elig. GS 6
5,981 (14.3) 5,626 (94.1) 355 (5.9)
Elig. GS 7
15,014 (36.0) 14,284 (95.1) 730 (4.9)
Not Elig. GS 6/7+

13,345 (32.0) 13,245 (99.3) 100 (0.7)

Not/adverse path.
 

Total 41,698 (100) 39,681 (95.2) 2,017 (4.8)

1 As previously defined on slide 3.

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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: Test Use:
“No” (%) “Yes” (%)
Not 6,971 (28.6) 6,780 (97.3) 191 (2.7)

Yes 17,404 (71.4) 16,723 (96.1) 681 (3.9)

Total 24,375 (100) 23,503 (96.4) 872 (3.6)

1
https://www.facs.org/search/cancer-programs
2
Analytic Cases (class of case 10-22), only.
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Results – Distribution by Overall Treatment 1

Overall Treatment Status by Prostate Oncotype DX Test Use

Treatment N (%) Test Use: Test Use:
Status “No” (%) “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
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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%)
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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.
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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.
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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.
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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
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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