Download If I could visualize my breast cancer in 10 years, would I make

If I could visualize my
breast cancer in 10 years,
would I make different
choices today?
Make informed decisions
precisely suited for you.
Proceed with confidence.
Unlock information unique to you
Look ahead to make decisions today
The decisions you make about your treatment take
careful consideration. When first diagnosed with
breast cancer, a lot of testing is done. The test results
are usually things your doctor can physically see, such
as the size of the tumor, what the cancer cells look
like, and if the cancer has spread. These results fit
together to help determine your treatment plan.
Prosigna is a genomic test which identifies the likelihood
your cancer may return to any part of your body over 10
years. This is known as distant recurrence. By assessing
your risk, Prosigna can provide a more complete
understanding of your breast cancer.
The Prosigna™ Breast Cancer Gene Signature Assay
measures information at a deeper biological level that
your doctor can’t see. It looks at 50 genes in your
cancer cells to see if they are present, absent, or too
active. Each woman’s breast cancer has unique traits
that reveal how your cancer might behave.
What your doctor
wants to understand
Examples of tools
and data your doctor
might use
Your potential
decisions, in
consultation with
your physician
Prosigna utilizes the PAM50 gene signature to find the
unique genetic fingerprint of your tumor, also referred to
as subtype. Using an automated process, your subtype
is combined with other factors including tumor size and
number of involved lymph nodes to help determine your
risk of distant recurrence. Looking ahead 10 years may
help you make more confident choices today.
Understanding stages
of breast cancer evaluation
Screening
Diagnosis
Treatment Planning
Am I at risk for cancer?
I have a lump. What is it?
Is it serious?
I had surgery to remove my
cancer. What is next?
Do you have family members with
breast cancer?
• Is it cancer or not?
• Is it early stage disease?
• Is it fast or slow growing?
• What are other traits of the tumor?
What type of treatment is most
likely to work for you?
Do you have genes or other factors that
might increase your risk?
• Physical exam
• Mammogram
• Ultrasound/ MRI
• Genetic counseling
• Genetic testing BRCA1, BRCA2
Using tissue from surgery:
• Tumor size
• Lymph node involvement
• Degree of hormone and protein
receptors present or absent such
as ER, PR, ki67, and HER2 status
• Type of screening
• Frequency of screening
• Preventative surgery (mastectomy)
Will I need to do more than remove
my tumor to treat and manage my
cancer?
What is the chance your cancer
will come back within 10 years?
Which treatment is right for
me, based on the likelihood my
cancer will return?
• Hormonal therapy
• Chemotherapy
• Radiation
• A combination of two or more
Proceed with confidence.
Personalize decisions about
your breast cancer
Begin with an accurate assessment
of risk
Historically, most breast cancers that were hormone
receptor positive would have received both hormonal
therapy and chemotherapy to lower the chance of the
cancer returning. Advancement in science has shown that
some types of breast cancer have a low risk of recurrence,
and may be sufficiently treated with hormone therapy
alone.1 Conversely, we know that tumors with a high risk
of recurrence will likely require more intense systemic
intervention. Understanding your risk of recurrence will help
identify a more personalized approach for your cancer.
A Prosigna report is delivered directly to your oncologist
and includes two important results:
Prosigna provides your physician additional information to
help accurately assess your risk category.
• Your Prosigna Score, which is a numerical value on a
0-to-100 scale. A lower number indicates your cancer
is less likely to return. A higher number indicates there is
a higher chance your cancer may return.
• Your Risk Category, (Low, Intermediate, or High)
indicates how likely your cancer will return within
10 years. Your risk status in combination with other
aspects, such as your age, other health issues, the
size and grade of your tumor, and hormone receptors
present in your breast cancer will help you and your
oncologist make the best treatment decision for you.
Use of a genomic breast cancer test
is suited for these characteristics
Newly diagnosed, early stage (I or II)
Invasive breast cancer treated
with endocrine therapy
Specimen
ID #:
Tumor Size: ≤ 2cm
Date Reported:
Lymph Nodes: Node-ne
Assay Description:
Patient
Specimen
ID #:
Tumor Size: ≤ 2cm
Date Reported:
Lymph Nodes: Node-negative
Comments
The Prosigna™ breast cancer gene signature assay measures the expressi
with the patient’s nodal status to assign a risk classification defined by presp
a proprietary algorithm based on the PAM50 gene signature1, and includes i
prototypical PAM50 molecular profiles, as well as proliferation and the patho
Assay Description:
The Prosigna™ breast cancer gene signature assay measures the expression of 58 different genes to report the Prosigna Score, which is used along
with the patient’s nodal status to assign a risk classification defined by prespecified Prosigna Score cutpoints.The Prosigna Score is derived from
a proprietary algorithm based on the PAM50 gene signature1, and includes information on the correlation of the tumor’s gene expression with four
prototypical PAM50 molecular profiles, as well as proliferation and the pathologic tumor size.
Patient Prosigna Score*:
Low Risk
Patient Prosigna Score*:
Low Risk
Intermediate Risk
0
100
Low Risk
Low Risk
Hormone receptor positive (ER or PR)
Intermed
25
High Risk
25
0
* The Prosigna Score ranges from 0 through 100 and correlates with the probability of distant recurrence (DR) in the tested population. Risk
classification is provided to guide the interpretation of the Prosigna Score using cutoffs related to clinical
outcome.
* The
Prosigna Score ranges
from 0 through 100 and correlates with the
classification is provided to guide the interpretation of the Prosigna Scor
Clinical
100 Trial Results:
0
25
Probability
of Distant Recurrence
100
Clinical Trial Results:
0
25
Probability
ofvarying
Distant
Recurrence
The Prosigna algorithm was used in retrospective analysis of the ABCSG-8 clinical trial which included
more than 1400 patients with
risks of
In the clinical
validation study, patients who were node-negative, with a Prosigna Score of 25 were in the low risk group.
80
Low Risk
100
The low risk population averaged a 3% probability of distant recurrence at 10 years.
distant recurrence.
The retrospectively fitted model relating Prosigna Score to 10-year distant recurrence for node-negative patients in the ABCSG-8
60
study is displayed below.†
In the clinical validation study,
†
100
40
Group
Average
[95% Cl]
80
20
60
0
patients who were node-negative, with
80
Low Risk
The low risk population averaged a 3% probability of distant recurrenc
Intermediate Risk
10% [7%–14%]
Low Risk
3% [2%–6%]
0
20
40
High Risk
The16%
Prosigna
[11%–22%]algorithm was used in retrospective analysis of the ABCSG-8
distant recurrence.
The retrospectively fitted model relating Prosigna Score
60
study is displayed below.†
Probability of Distant Recurrence at 10 Years (%)
Probability of Distant Recurrence at 10 Years (%)
Lymph node-negative or
Lymph node-positive with
1-3 positive nodes
Patient
60
40
20
0
0
20
40
60
Prosigna Score
80
100
100
40
Group
Average
[95% Cl]
80
20
80
Low Risk
3% [2%–6%]
Intermed
10% [7
100
60
0
Modeled Probability
0
95% Confidence Interval (CI)
Observed Probability‡
20
40
20
40
40
Data apply to patients being treated with endocrine therapy for 5 years as in the tested patient population. See Package Insert for further information
on therapeutic regimens and tested patient population. It is unknown whether these findings can be extended to other patient populations or treatment
schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10 Prosigna Score units.
20
NanoString Technologies, Inc. 530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
© 2013 NanoString Technologies, Inc.
For more information, visit PROSIGNA.com or e-mail [email protected]
0
0
Sample Prosigna Patient Report: Low Risk of Recurrence
Proceed with confidence.
†
Prosign
Data apply to patients being treated with endocrine therapy for 5 years as
on therapeutic regimens and tested patient population. It is unknown whet
schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10
Getting tested is easy
Ask your surgeon and/or oncologist how Prosigna can
help guide your decisions. The Prosigna test does not
require additional surgery or needle sticks. Prosigna
can be performed on tissue preserved from your
original surgery. It is the only breast cancer genomic
test that is FDA-cleared to use this type of tissue*. Ask
your doctor today for your Prosigna results.
Prosigna is indicated for use in postmenopausal
women with hormone receptor-positive, nodenegative or node-positive early-stage (stages I and II)
breast cancer to be treated with adjuvant endocrine
(hormone) therapy when used in conjunction with other
clinicopathologic factors. Prosigna is not intended for
diagnosis, to predict or detect response to therapy, or
to help select the optimal therapy for patients.
Helping breast cancer
patients access
important diagnostic
information
Patient Support Program
The Prosigna Patient Support Program
(PPSP) offers a range of services to help
patients access Prosigna.
See the Prosigna Package Insert for full intended use.
*formalin-fixed paraffin embedded tissue
Prosigna demonstrated the ability to
accurately predict distant recurrence in
clinical studies of over 2400 patients,
of which over 1000 were compared
directly to first-generation genomic
breast cancer assays.
Enrollment in PPSP
Resource counselors are available to help patients who
are uninsured or have been denied coverage
by their insurance provider and can address
concerns regarding out-of-pocket costs.
To determine if you qualify for the patient
assistance program, enroll today. Call
855-4PROSIGNA to speak with a resource
counselor.
Proceed with confidence.
REFERENCES:
1. Gnant M. Ann Oncol 2013 doi: 10.1093/annonc/mdt494
2. Prosigna [Package Insert]. Seattle, WA: NanoString
Technologies, Inc.; 2013
NanoString Technologies, Inc.
530 Fairview Ave N., Suite 2000
Seattle, WA 98109
www.nanostring.com
For more information visit www.prosigna.com
or email [email protected]
© 2014 NanoString Technologies. All rights reserved.
NanoString Technologies logo, Prosigna and the Prosigna logo
are registered trademarks and/or trademarks of NanoString
Technologies, Inc. in various jurisdictions.