Download HAVE YOU BEEN NEWLY DIAGNOSED with DCIS?

HAVE YOU BEEN NEWLY
DIAGNOSED with DCIS?
Jen D.
Mother and volunteer.
Diagnosed with DCIS
breast cancer in 2012.
An educational guide prepared by Genomic Health®
This guide is designed to educate women newly diagnosed
with DCIS about the Oncotype DX® Test, a diagnostic test
that may help you and your doctor make a more informed
treatment decision based on your tumor’s biology.
“I had my Surgical Oncologist, my Medical
Oncologist, and my Radiation Oncologist
in the room with me discussing my
treatment options. There was only one
way to start: The Oncotype DX® Test for
DCIS, which would determine what my
individual risk of recurrence would be
for DCIS.”
Carol F., nurse and grandmother.
Diagnosed with DCIS breast cancer in 2012.
4
2
H
ave you recently been diagnosed
with a non-invasive form of breast
cancer called DCIS? Are you struggling
to understand what your treatment
options are?
DCIS is one of the most commonly
diagnosed breast conditions. It is
considered to be an early, non-invasive
form of breast cancer.1
•Ductal carcinoma means the tumor is
within the milk ducts
•In situ means it is in its original place
and has not spread beyond the ducts
It is overwhelming to get the diagnosis.
Even after therapy, women with DCIS are
at increased risk for the cancer coming
back in the same breast (called local
recurrence), either as DCIS or as invasive
breast cancer.
Planning Your Treatment
After a diagnosis of DCIS, the first step is
usually surgery to remove the DCIS tumor.
Following surgery, the next step is to
determine how likely your cancer is to
return, which may help you and your
doctor make decisions about future
treatment options.
This education piece is not designed to provide
individual advice in connection with your diagnosis
or treatment plan. Such matters should be discussed
with your healthcare provider.
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Gathering Information
to Help Make the Right
Treatment Decision—for You
There are several treatments for DCIS
after surgery, so it is important to gather
as much information as possible to
decide on a treatment plan that is right
for you. Your doctor may consider many
factors in planning your treatment,
including:
•your medical history
•your age
•size and grade of your DCIS tumor
•whether your tumor cells have
estrogen receptors
•surgical procedures, including
margin width
•the results of your Oncotype DX® Test
•your treatment preferences
Because every woman’s breast cancer is
unique, you and your doctor will need to
understand the underlying biology of your
tumor to further individualize your
treatment plan.
What Is the Oncotype DX® Test?
The Oncotype DX® Test for DCIS is a
genomic diagnostic breast cancer test
that measures a group of cancer genes
in your DCIS tumor. Studies show that
the results from the Oncotype DX Test
strongly predict whether cancer may
come back in the same breast.2
4
“The Oncotype DX Test was a really key
piece of evidence for me. My DCIS Score
result helped me assess the risks and
confirmed my treatment decision.”
5
“I had always thought of DCIS as ‘cancerlite’… but it’s really not. The uncertainty
was incredibly unsettling and that was
why the Oncotype DX Test was so helpful
for me. It helped to make concrete
something that no one could see.”
4
6
Why Should I Consider the
Oncotype DX® Test?
This is a unique test that provides
information specific to your tumor,
not available from traditional factors.
Since the Oncotype DX® Test provides
individualized information, it enables the
treatment plan to be tailored specifically
for you. It gives you and your doctor a
better understanding of how your DCIS
tumor behaves.
In the past, most patients with DCIS have
received aggressive treatment. This meant
some women with DCIS may have received
therapy that provided limited benefit.
Now, the Oncotype DX Test for DCIS can
help identify low-risk and high-risk DCIS.
With this information, the treatment plan
can be tailored specifically for you.
Speak with your healthcare team to
understand how the Oncotype DX Test
results may impact your treatment plan.
Is the Oncotype DX Test Right
for Me?
The test may be right for you if you are
planning treatment after surgery, and:
•are newly diagnosed with DCIS
breast cancer
•have had breast-conserving surgery
(lumpectomy) and not total mastectomy
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How Will the Oncotype DX® Test
Help Me and My Doctor?
The test will tell you and your doctor the
chances of your tumor coming back, which
may help guide treatment decisions. Your
doctor will receive a report with the
results of the Oncotype DX® Test. The
report contains your DCIS Score™ result,
a number between 0 and 100.
•Women with lower DCIS Score results
have a lower risk that their cancer
may return and may be treated
more conservatively
•Women with higher DCIS Score results
have a greater chance that their breast
cancer may return and may benefit
from additional therapies
How Is the Oncotype DX Test
Performed?
The test is performed on a small amount
of your DCIS tumor tissue that was removed
during your original surgery (lumpectomy
or core biopsy). This tissue is routinely
saved and stored at the hospital where
you had your surgery. You will NOT have
to go through any additional surgery or
procedure to get the Oncotype DX Test.
When your doctor orders the Oncotype DX
Test, the hospital will send a sample of your
tissue to Genomic Health, the laboratory
that performs the Oncotype DX Test.
4
8
“One of the most important resources
was learning that I had a higher risk of
recurrence (because my DCIS score was
high), so I chose radiation as part of
my treatment plan. Most important were
my physicians (who were aware of the
importance of the Oncotype DX Test),
my friends, my peers, and most of all,
my family.”
5
9
“The most important things I took away
from my Oncotype DX experience were
knowledge and the empowerment to
make my treatment decision.”
4
10
How Has the Oncotype DX® Test
Been Studied?
The Oncotype DX® Test for DCIS has been
studied in a trial with over 300 women
with DCIS, demonstrating accuracy and
consistency. The company’s first test,
Oncotype DX Test for invasive breast
cancer, has been studied in multiple
trials involving more than 4000 women.3-9
In addition to DCIS, Genomic Health
(the company that developed the
Oncotype DX Test) offers tests for invasive
breast cancer and colon cancer. To date,
the Oncotype DX Test (for both invasive
breast cancer and colon cancer) has been
ordered by over 10,000 doctors in over 65
countries for more than 320,000 patients.10
To learn more about these trials, please
visit www.oncotypeDX.com.
When Should the Oncotype DX
Test Be Done?
It is important that
your doctor request
the Oncotype DX Test
before you start any
treatment, since the
test is intended to
help determine how
likely your cancer
is to return, which
may guide treatment
decisions.
Surgery to remove tumor
Doctor orders the
Oncotype DX Test
Hospital sends sample
of tumor to the Genomic
Health laboratory
The Genomic Health
laboratory analyzes
the 21 genes
Doctor receives the
Recurrence Score™ result
Doctor and patient
discuss the results and
personalize treatment
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How Do I Get the
Oncotype DX® Test?
The test can only be ordered by a licensed
healthcare professional, such as your
doctor. You may wish to share this
brochure with your doctor and ask if
the Oncotype DX® Test may be of benefit
to you.
How Long Will It Take to Get the
Results of the Oncotype DX Test?
Most results from the Oncotype DX Test
are available within 7 to 10 days from the
date the tumor sample is received by the
Genomic Health® laboratory. The results
are sent to your doctor so that he or she
can discuss the results with you and
answer your questions.
Understanding Your
DCIS Score™ Result
The Oncotype DX Test produces a unique
DCIS Score result, a number between
0 and 100.
•Women with lower DCIS Score
results have a lower risk that their
cancer may come back in the same
breast (local recurrence), either as
DCIS or as an invasive tumor. It does
not mean that there is no chance
of the cancer returning
4
12
“Having the Oncotype DX Test gave me
peace of mind that I was making the
right decision for me.”
5
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•Women with higher DCIS Score™ results
have a greater risk their cancer may
come back in the same breast. It does
not mean that cancer will definitely
return, but it means that you may
want to consider additional therapies
The Oncotype DX® Test will also provide
information about the activity levels of
hormone receptors in your tumor, which
may help further guide your treatment.
Is the Oncotype DX® Test
Covered by Insurance?
Once you and your doctor agree the
Oncotype DX Test is right for you, you
will likely want to find out if it is covered
by your insurance. Coverage varies by
insurance plan for all medical services
and benefits. Genomic Health, the
company that developed and performs
the Oncotype DX Test, has a program
called GAP (Genomic Access Program)
to help you through the process.
GAP can help you find out if the test
is covered and help process the claim
once the test is complete. GAP can
also help with the appeal process
if your claim is denied. GAP also offers
financial assistance for all patients
who qualify (including uninsured and
underinsured patients).
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Please note that you may be financially
responsible for some or all costs
associated with the Oncotype DX Test.
For specific insurance and financialaid questions, please contact
Genomic Health® Customer Service
at 866-ONCOTYPE (866-662-6897)
and we will be happy to assist you.
For additional resources and
information, please visit
www.mybreastcancertreatment.org
or www.oncotypedx.com.
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List of Terms
Assay: A laboratory test.
Cancer: A term for diseases in which
abnormal cells divide without control
or order. Cancer cells can invade nearby
tissues and can spread through the
bloodstream and lymph nodes to other
parts of the body.
Cell: The smallest unit of a tissue that
makes up any living thing. Cells have a
very specialized structure and function.
Chemotherapy: Treatment with drugs to
destroy or slow the growth of cancer cells.
Clinical Trial: A research study where
patients help scientists evaluate ways to
prevent, detect, diagnose, or treat diseases.
Ductal Carcinoma in situ (DCIS): An early
or non-invasive form of breast cancer that
is confined to the milk ducts within the
breast, and is considered Stage 0 disease.
Early-Stage Breast Cancer: Breast cancer
is categorized by stage based on the size
of the tumor and whether the cancer has
spread. Stages I, IIA, IIB, and IIIA are
considered early stage and refer to
cancers that may have spread to nearby
lymph nodes but not to distant parts
of the body.
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Gene: The basic unit of heredity found
in most cells of the body.
Genomics: The study of complex sets of
genes, their expression (level of activity),
and their effects on biology.
Hormonal Therapy: The use of specific
drugs, such as tamoxifen or aromatase
inhibitors, to reduce or regulate the
production or effects of hormones in
the body.
Lumpectomy: A surgical procedure that
removes a localized mass of tissue,
including the breast cancer tumor and
a small amount of tissue surrounding
the tumor.
Margin: Healthy normal tissue that
surrounds the edge of the tumor tissue
that is removed during surgery. Negative
or clear margin means the cancer was
entirely removed; positive margin means
some cancer cells still remain after surgery.
Mastectomy: A surgical procedure
to remove all or part of the breast.
Newly Diagnosed: A term used
to describe breast cancer that has
recently been identified in a patient.
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Oncotype DX® Test: The Oncotype DX®
Tests are unique diagnostic tests that
look at the genomic profile of a tumor.
Radiation: The use of radiation to
destroy cancer cells. Radiation therapy
may be used before or after surgery,
and is sometimes used in combination
with chemotherapy. Radiation is used
for local control of the cancer at the site
of the tumor.
Tumor: Tissue growth in which the
cells that make up the tissue have
multiplied uncontrollably. A tumor
can be benign (noncancerous)
or malignant (cancerous).
Tumor Grade: Characterization of
a tumor based on how similar the
cancer cells are to normal cells.
Tumor Size: How big the tumor is,
usually reported in metric units
(millimeters or centimeters).
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“The Oncotype DX Test solidified the
direction I wanted to go. I think I would
have been considerably more uncertain
about my final decision without knowing
the DCIS Score™ Result.”
5
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To learn more about the Oncotype DX® Test,
visit www.mybreastcancertreatment.org
and talk to your healthcare team. For
insurance, financial aid, or other questions
about the Oncotype DX Test, please call US
(English) 866-ONCOTYPE (866-662-6897),
US (Spanish) 877-444-9876, and
international 001-650-569-2080.
For more information about this and
other Oncotype DX tests, please
visit www.genomichealth.com
or www.oncotypeDX.com.
The people shown in this booklet used the Oncotype DX
Breast Cancer Test in making their treatment decisions
with their physicians.
References: 1. Polyak et al. J Natl Cancer Inst Monogr. 2010. 2. Solin et al. SABCS 2011. Abstract
S4-6. 3. Dowsett et al. J Clin Oncol. 2010. 4. Albain et al. Lancet Oncol. 2010. 5. Goldstein et al.
J Clin Oncol. 2008. 6. Paik et al. J Clin Oncol. 2006. 7. Habel et al. Breast Cancer Res. 2006.
8. Paik et al. ASCO 2005. Abstract 510. 9. Paik et al. N Engl J Med. 2004. 10. Data on file.
Genomic Health, Inc. Redwood City, CA.
Genomic Health, Oncotype DX, DCIS Score, and Uncover the Unexpected are trademarks
of Genomic Health, Inc.
©2012 Genomic Health, Inc. All rights reserved. GHI10176_1112
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