Download Oncotype DX® Colon Cancer Assay Recurrence Score® results

For newly diagnosed patients with stage II colon cancer
Oncotype DX Colon Cancer
Assay Recurrence Score
results change treatment
decisions 29% of the time
®
®
Background
• The Oncotype DX Colon Cancer Assay analyzes the expression of
12 genes to provide a Recurrence Score result unique to each
patient
• The Recurrence Score result was clinically validated as a
predictor of recurrence risk, providing clinical value beyond
other available measures, in two prospectively designed studies
of over 2,100 stage II colon cancer patients1, 2
Study design
Objective
•Investigate the impact of the Oncotype DX Colon Cancer Assay
Recurrence Score results on adjuvant treatment decisions in
stage II colon cancer3
Primary endpoint
Patient characteristics (N=116)3
Age, years
Mean (SD)
61.3
(11.8)
62
(32– 85)
Median (range)
• The total proportion of treatment decisions that changed
after the medical oncologists received the 12-gene
Recurrence Score results
T-stage
n
(%)
T3
94
(81%)
T4
22
(19%)
Methods
Number of lymph nodes examined
≤8
4
(3%)
9 –11
15
(13%)
≥12
97
(84%)
MMR-D/MSI-H
13
(17%)
MMR-P/MSI-low
46
(61%)
Unknown
17
(22%)
• Web-based survey conducted from December 2010 to
December 2011 included 346 US physicians who had
ordered the Oncotype DX Colon Cancer Assay for
≥3 patients with stage II colon cancer
• 116 physicians completed the survey focusing on the single
most recent stage II colon cancer patient for whom the
Oncotype DX assay was ordered
• 92 physicians had made a treatment decision prior
to ordering the Oncotype DX Colon Cancer Assay
MMR tested (n=76)
For newly diagnosed patients with stage II colon cancer
By revealing underlying tumor biology,
the Oncotype DX Colon Cancer Assay led to
a different treatment approach in 29% of patients
®
Results
Summary
29% of treatment decisions (27/92) changed
based on Recurrence Score® results :
29%
3
changed
• Treatment intensity decreased
for 67% (18/27) of patients
• Treatment intensity increased
for 33% (9/27) of patients
71% confirmed
This study suggests that the Oncotype DX
Colon Cancer Assay Recurrence Score
result may lead to reductions in
treatment intensity: 29% of treatment
decisions changed based on Recurrence
Score results, and two-thirds of the
changes resulted in decreased treatment
intensity
Increased intensity was defined as change from observation to (any) chemotherapy or a change from non–oxaliplatin-containing
to oxaliplatin-containing chemotherapy.
Decreased intensity was defined as a change from (any) chemotherapy to observation or a change from oxaliplatin-containing
to non–oxaliplatin-containing chemotherapy.
Pre- vs Post-Assay Treatment Decisions (n=92)3
Pre-Assay (N)
Post-Assay (N)
Observation
Non-Oxaliplatin
Chemotherapy
Oxaliplatin
Chemotherapy
Pre-Assay
Total
Observation
31
4
5
40
Non-Oxaliplatin
Chemotherapy
6
13
0
19
Oxaliplatin
Chemotherapy
8
4
21
33
Post-Assay
Total
45
21
26
92
Recurrence Score Tertiles3
Treatment Intensity
Low
RS <16
Mid
16 ≤ RS <25
High
RS ≥25
Total
Change
12 (39%)
9 (31%)
6 (19%)
27 (29%)
Decreased
10 (32%)
7 (24%)
1 (3%)
18 (20%)
Increased
2 (6%)
2 (7%)
5 (16%)
9 (10%)
No Change
19 (61%)
20 (69%)
26 (81%)
65 (71%)
Total
31 (100%)
29 (100%)
32 (100%)
92 (100%)
For more information regarding the
Oncotype DX Colon Cancer Assay,
please contact customer service
at 866-ONCOTYPE (866-662-6897)
in the US, or 001-650-569-2080
outside the US
Expanding payor coverage includes
both public and private payors
www.oncotypeDX.com
References: 1. Venook et al. J Clin Oncol. 2011. 2. Gray et al. J Clin Oncol. 2011. 3. Cartwright et al. ASCO 2012. Abstract #3626
© 2012 Genomic Health, Inc. All rights reserved. Genomic Health, Oncotype DX, Recurrence Score, and Confidence. Confirmed. are trademarks of Genomic Health, Inc.
GHI30043_0612
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196-30587
Job Title:
Colon Cancer Sell Sheet
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