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Advocate Resources and Information
If you would like any of these documents in a Microsoft Word format, please feel free to contact:
Cheya Pope
Director of Advocacy at Genomic Health
[email protected]
CONTENTS
About Oncotype DX®............................................................................................. 3
Oncotype DX® for Stage II Colon Cancer ............................................................. 4
Oncotype DX® Colon Cancer Assay Development ............................................... 6
Step-by-Step Oncotype DX® Process ................................................................... 8
Oncotype DX® Colon Cancer Assay Logistics ..................................................... 10
Patient Access Information and Resources ......................................................... 12
Genomic Access Program ................................................................................. 13
Questions for Newly Diagnosed Patients .......................................................... 15
Genomics Fact Sheet ........................................................................................ 16
Recurrence Fact Sheet ...................................................................................... 18
Advocate Resources ............................................................................................ 20
Sample Newsletter Article ................................................................................ 21
Oncotype DX® Frequently Asked Questions ...................................................... 23
Glossary ............................................................................................................ 28
2
ABOUT ONCOTYPE DX®
3
ONCOTYPE DX® FOR STAGE II COLON CANCER
Oncotype DX is a diagnostic test for patients who are newly diagnosed with stage II colon cancer. The
test works by examining the tumor tissue at a molecular level, in order to provide information about the
individual biology of each patient’s tumor. Oncotype DX does this by evaluating 12 genes within the
colon tumor to determine the likelihood that the cancer cells will spread – or metastasize – within three
years of diagnosis.
The measurement of these 12 genes is combined into an individualized result called a Recurrence
Score®. The Recurrence Score is a number between 1 and 100 that correlates with the likelihood that an
individual patient’s colon cancer will recur. This information can help patients and their healthcare
providers make more informed decisions about whether or not to pursue additional treatment – such as
chemotherapy – following the surgery to remove the tumor.
Currently, physicians use standard measures such as T-stage (the extent of the cancer), tumor grade,
and lymph node status to assess recurrence risk in stage II colon cancer patients. While these
characteristics are important, the additional genomic information provided by the Oncotype DX test can
help patients and their physicians create a tailored treatment plan based on the unique biology of each
tumor.
Who Should Consider the Oncotype DX Test?
For people recently diagnosed with Stage II colon cancer, the Oncotype DX test may be appropriate. The
decision to use the Oncotype DX test is one that patients and their physicians should discuss and make
together.
How is Oncotype DX Performed?
Oncotype DX is a noninvasive test performed on a small amount of the tumor tissue removed during a
patient’s original surgery. This means patients do not have to undergo any additional invasive
procedures for the Oncotype DX test to be performed.
After surgery, a sample of the patient’s tumor tissue is preserved and placed into a small container for
further diagnostic testing. To perform Oncotype DX, the hospital will send several thin sections of the
preserved tumor tissue (or the whole tissue block) to the licensed Genomic Health laboratory in
California, where the test was developed and is performed.
When a tumor sample arrives at Genomic Health, the RNA – which is present in the tumor – is extracted
and then analyzed to determine the level of activity or expression of each of 12 genes. Seven of these
genes measure recurrence and five are reference genes. The results of the analysis are then put into a
complex mathematical equation to convert those measurements into the Recurrence Score result. The
Oncotype DX test results are then integrated with other laboratory test results and other clinical findings
to help patients and physicians develop an individualized treatment plan based on the unique biology of
each person’s tumor.
How Does Oncotype DX Report the Results?
A detailed report is generated and sent to the healthcare provider who ordered the test, including a
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Recurrence Score result. The Recurrence Score is a number between 1 and 100 that corresponds to a
specific likelihood that colon cancer will return – or metastasize – within three years of initial diagnosis.
A lower Recurrence Score result is considered to have a lower risk for colon cancer recurrence than a
higher score. However, a lower risk score does not necessarily mean that colon cancer will never recur,
and a higher risk score does not always mean that colon cancer will recur.
How Can Oncotype DX Benefit Patients?
All colon cancer tumors are unique, and at Genomic Health, scientists noted that individual tumors
behave in different ways based on their distinctive genomic make-up. The information contained in the
biology of the tumor – when used in tandem with other factors – can provide crucial information about
the inner workings of that tumor. By examining the precise make-up of a group of 12 genes at the
molecular level, Oncotype DX provides a snapshot of the tumor’s individual behavior, which varies from
patient to patient.
There are many ways in which Oncotype DX can help patients and physicians better understand a stage
II colon cancer diagnosis:
 The Recurrence Score result will help illuminate the likelihood that the colon cancer will recur – or
spread – within three years of the initial diagnosis
 This information, in turn, can help patients and physicians determine whether or not additional
treatment – such as chemotherapy – is appropriate to consider following surgery
 This can help both patients and doctors to gain confidence in their treatment decision
Based on this, the Oncotype DX test can be a vital step in the treatment planning process. And
remember, patients do not need to undergo any additional invasive procedures to get the results of the
Oncotype DX test.
How Can Patients Get Tested?
Oncotype DX is a diagnostic test that can only be ordered by an authorized healthcare provider, who
submits the tumor tissue sample to the Genomic Health® lab for analysis. The results of the Oncotype
DX test are reported to the ordering physician within 10 to 14 days from the date the tumor sample
arrives at Genomic Health. For more information, visit www.oncotypedx.com or call 866-ONCOTYPE.
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ONCOTYPE DX® COLON CANCER ASSAY DEVELOPMENT
The Oncotype DX colon cancer test was developed from multiple clinical trials using colon cancer tumor
samples that had been stored—or archived—following surgery.
Developmental Work Conducted by Prestigious Research Institutions
First, the National Surgical Breast and Bowel Project conducted three development studies and the
Cleveland Clinic Foundation conducted one development study with Genomic Health, analyzing genes
from over 1000 patients with stage II colon cancer. Detailed analysis of gene expression and colon
cancer recurrence was performed to identify genes with the potential to predict the likelihood of cancer
recurrence and response to chemotherapy.
Genomic Health selected a specific set of 12 genes from these early studies, made up of seven
recurrence genes and five reference genes. After analyzing hundreds of samples, we developed a
complex mathematical calculation to combine the expression of these genes into an equation that
predicts the likelihood of distant disease recurrence with precision. This formula results in a number,
the Recurrence Score® result, which the patient’s physician can interpret.
QUASAR Validation Study
After completing the gene identification process and creating the Recurrence Score algorithm, the final
set of 12 genes were then independently evaluated in 1,436 tumor samples from stage II colon cancer
patients who had participated in the landmark QUASAR clinical study that was conducted in the 1980s
(Lancet 370:2020, 2007), to evaluate whether or not those patients would benefit from undergoing a
regimen of 5FU/LV chemotherapy following surgery. The 12 genes were also examined to determine
whether they would be useful beyond other key variables including tumor stage, tumor grade, and the
number of lymph nodes examined.
Here are the details of that validation study:
 Samples were collected from patients who participated in an international, multi-center
randomized trial that examined the benefit associated with an adjuvant 5fluorouracil/leucovorin (5FU/LV) chemotherapy regimen for patients with stage II colon cancer.
 The majority of samples for this analysis of the Oncotype DX colon cancer assay were from the
United Kingdom.
 Gene expression was quantified using Genomic Health’s RT-PCR technology on manually
microdissected fixed paraffin-embedded primary colon cancer tissue.
 Recurrence-free interval, disease-free survival, and overall survival were analyzed using Cox
regression analyses.
This analysis of QUASAR samples found that the Oncotype DX colon cancer Recurrence Score® result
independently predicts individualized recurrence risk for stage II colon cancer (p=0.008), providing
clinical value beyond standard measures.
Based on the positive QUASAR results, Genomic Health has proceeded with commercialization plans and
the 12 gene Oncotype DX colon cancer test was made available to physicians and patients in early 2010.
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Joining a Franchise Legacy
The Oncotype DX colon test is the second genomic test developed by Genomic Health to help improve
the quality of treatment decisions for cancer patients and their physicians. Since 2004 Genomic Health
has marketed its widely-adopted Oncotype DX breast cancer test, which is clinically validated to predict
the likelihood of recurrence and chemotherapy benefit in early-stage breast cancer. Since its launch,
physicians have ordered more than 135,000 Oncotype DX tests for their breast cancer patients.
The use of Oncotype DX has become standard practice in the oncology community for certain types of
breast cancer and it is the only multi-gene expression test recommended by the American Society of
Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) treatment guidelines
based on its ability to determine which early-stage breast cancer patients are likely to benefit from
chemotherapy.
Additionally, research from the 2007 and 2009 San Antonio Breast Cancer Symposiums indicates that
Oncotype DX may also be informative for postmenopausal women with ER+, node-positive stage 2-3
breast cancer. Studies of Oncotype DX in additional breast cancer populations are ongoing, and
Genomic Health is developing new diagnostics for other types of cancer.
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STEP-BY-STEP ONCOTYPE DX® PROCESS
Colon cancer diagnosis
A tumor is identified in your colon through a colonoscopy or other screening methods. Surgery is the
main treatment for most colon cancers. The tumor and surrounding tissue including the lymph nodes
are removed and sent to the pathology laboratory for a detailed assessment of your disease.
Laboratory analysis
In the laboratory, your tumor is preserved – or fixed – and embedded in paraffin (wax). The formalinfixed paraffin-embedded (FFPE) tumor tissue is then sectioned for use in histological analysis, which is
the study of thin slices of tissue, as well as other tumor assessment techniques.
If you are diagnosed with stage II cancer, the Oncotype DX® test can be ordered by your healthcare
provider. Once the test is ordered, your specimen is sent out by the local pathology lab where the
tumor tissue was stored following your surgery. The tumor block or several thin sections of your tumor
are sent to the Genomic Health® lab. If sections of the tumor are sent, the pathologist places those
tumor samples in the tubes provided by Genomic Health. In addition, a slide is prepared with a section
of the tumor tissue. The tumor block or tubes are placed in the Oncotype DX Specimen Kit for shipping
to Genomic Health, along with the slide and the completed test requisition form.
Oncotype DX process
Your tumor specimen and requisition form for Oncotype DX are then received at Genomic Health and
logged into the Genomic Health system. The specimens are scanned in to initiate the Oncotype DX
process. RNA (part of the genomic makeup of the cells) is then extracted from your tumor sample and
analyzed to determine the level of activity – or expression – of each of 12 genes. Finally, the results of
the analysis are then put into a mathematical equation to convert those measurements into a
Recurrence Score® result.
Results
A detailed report is generated for your healthcare provider to share with you, with the test results
provided as a Recurrence Score report. The Recurrence Score is a number between 0 and 100 that
corresponds to a specific likelihood of experiencing a colon cancer recurrence within three years of your
initial diagnosis. This form is then delivered to your healthcare practitioner via overnight mail, fax,
and/or secure electronic delivery.
Treatment planning
The results of Oncotype DX are intended to be used in conjunction with the results of other laboratory
tests that are performed to evaluate your colon cancer. With the set of results from the tumor analysis,
you and your healthcare practitioner can then understand how likely your cancer is to return. Based on
that information, you can discuss appropriate therapy options and form a treatment plan based on the
specific attributes of your tumor.
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In order for you and your healthcare provider to determine whether chemotherapy will be an
appropriate treatment option following your surgery, it is important to understand both the benefits
and the risks associated with chemotherapy.
If you have a lower chance of experiencing a colon cancer recurrence, you may decide that the benefit
of chemotherapy may not be large enough to outweigh the risk of its side effects. And if you have a
higher likelihood of a colon cancer recurrence, you may find that the potential benefit of chemotherapy
outweighs the potential side effects. Therefore, the decision to use chemotherapy is one that you and
your doctor should discuss and make together based on information from tools such as Oncotype DX.
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ONCOTYPE DX® COLON CANCER ASSAY LOGISTICS
Your tumor sample for the Oncotype DX test is submitted for analysis to the Genomic Health®
Laboratory, a licensed reference laboratory with a Certificate of Accreditation under the Clinical
Laboratory Improvement Amendments (CLIA). Genomic Health is also a CAP (College of American
Pathologists) accredited reference laboratory.
Specimen Requirements
Tumor analysis requires formalin-fixed, paraffin (wax)-embedded tumor tissue. This is the standard
method hospitals and clinics use to preserve tissue removed during surgery.
To perform the Oncotype DX test, Genomic Health requires one formalin-fixed paraffin-embedded
tumor block OR fifteen unstained slides.
The materials necessary for collecting your tumor sample and submitting it to Genomic Health are all
provided in the Oncotype DX Specimen Kit.
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Oncotype DX Results
Results of the Oncotype DX test are available 10 to 14 days from the date the tumor sample is received
at Genomic Health. Results are sent by fax, overnight mail, and/or secure online transfer to the treating
physicians and submitting pathologist.
If you are have recently been diagnosed with stage II colon cancer and have not yet begun a
chemotherapy treatment regimen, the Oncotype DX test may be appropriate for you. However, the
decision to use the Oncotype DX test is one that you and your doctor should discuss and make together.
The Oncotype DX report is based upon Genomic Health’s analysis of the submitted specimen and
information provided on the Requisition Form (including the Comments Section). Additional
information (including pathology reports) submitted with the specimen is generally not considered in
analyzing the specimen or preparing the report.
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PATIENT ACCESS INFORMATION
AND RESOURCES
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GENOMIC ACCESS PROGRAM
At Genomic Health® we recognize that new technologies such as Oncotype DX® assays are only helpful
to patients if they are accessible to patients. Therefore, we are constantly working to make sure that all
people who are medically eligible for Oncotype DX testing have the opportunity to access the service.
Because the Oncotype DX Colon Assay is so new, we are currently working closely with insurers across
the country – including Medicare, Anthem Wellpoint, Aetna, CIGNA, Kaiser Permanente, and many
others – to secure reimbursement for the test, as part of our commitment to helping patients access the
important information that this test generates.
In addition, Genomic Health has created the Genomic Access Program (GAP) to support all patients in
navigating the insurance process. Specifically, we assist patients with benefits investigations to
determine whether their insurance covers the test. We also directly bill insurance plans on behalf of
insured patients in the United States whose physicians order the Oncotype DX test.
If an insurer requires a prior authorization before we can begin processing the patient’s tumor
specimen, our GAP team can also help facilitate that process. If a claim is denied on first review, our
team can appeal this denial on the patient’s behalf, with input from the patient’s physician as needed.
In those cases in which all appeals are exhausted and the claim is not fully paid, the patient may
ultimately be responsible for any balance remaining on the invoice. However, Genomic Health GAP
services include a patient assistance program to support eligible patients facing a financial hardship—
including both uninsured and underinsured patients.
Throughout the entire process, our reimbursement professionals will assist patients in their efforts to
obtain coverage for this test, and we encourage you to contact GAP if you have questions.
What can GAP do for you?
Patients have access to the following services through GAP:
Benefits investigations
GAP representatives will work with your insurance carrier to determine what benefits you have for
clinical laboratory testing. (Obtaining benefits information up front does not guarantee payment by the
insurance company once the claim is filed.) GAP representatives will relay this information to you and
your physician.
Prior authorizations
If your plan requires prior authorization for this test, GAP representatives will work with you and your
physician to help obtain the authorization. Please note: obtaining prior authorization is not always a
guarantee of payment by the insurance carrier.
Claims processing
Once your Oncotype DX test result has been sent to your doctor, Genomic Health will submit the claim
to your insurance carrier for payment. We will also keep you updated on the status of your claim.
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Appeals
If your insurance carrier refuses to pay for all or a portion of the cost of your test, GAP representatives
will work with you to submit an appeal. GAP is committed to completing up to three levels of appeals,
including independent medical review, if available in your state. The actual number of appeals allowed
by your carrier depends upon your individual plan and is determined when the appeal process begins.
We may ask you and your physician to assist in the process as needed.
Patient Assistance Program
GAP representatives are committed to working with you through the reimbursement process. We also
offer the following programs:
 Financial assistance for qualifying un- and under-insured patients
 Assistance with balances due (if eligible for the program)
 Payment plans to meet your financial situation
When to contact GAP
Prior to having the test
 You or your doctor may request a benefits investigation. GAP will contact you with the results
within 48 business hours.
Once you receive your Oncotype DX test results
 Genomic Health will submit the claim for payment. GAP will update you regularly on the status of
the claim.
 If your claim is denied, GAP can submit the appeal on your behalf and update you on the status of
the appeal. You may receive information directly from your insurer or be required to submit the
appeal yourself. In these cases, please contact GAP for assistance.
 If Genomic Health receives payment from your insurance company, but you still owe a balance, you
may request that GAP determine if you are eligible for financial assistance and/or a payment plan.
 If your insurance carrier refuses to pay after appeals have been exhausted, GAP will work with you,
at your request, to determine if you are eligible for financial assistance or a payment plan.
The Genomic Access Program can be reached via phone at 866-ONCOTYPE or online at
http://www.oncotypedx.com/PatientCaregiver/InsuranceInfo.aspx?Sid=3.
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QUESTIONS FOR NEWLY DIAGNOSED PATIENTS
It is important to understand what type of colon cancer you have, because that has a direct bearing on
the treatment options your doctor will consider for you. Here are some questions you may want to ask
your doctor to help you gather information about your cancer. Please check the glossary for definitions
on the following terms:
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Is my cancer invasive?
Has my cancer metastasized?
What is my lymph node status?
How large is my tumor?
What grade is my tumor?
How likely is my cancer to spread or return?
What treatments do you think I will need? What information are you using for each treatment
recommendation?
Which tests can tell me more about my individual cancer and whether I am likely to experience
a recurrence? Am I a candidate for such tests and, if so, what are the benefits and limitations of
the tests?
How can I get a copy of my pathology report and testing information?
As the last question above suggests, it is important to obtain a copy of your pathology report from your
doctor. This is a key step in staying informed about your colon cancer and your treatment. If you need
additional information from your doctor, or would like your doctor to re-phrase an answer so that it is
clearer and easier to understand, be sure to ask.
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GENOMICS FACT SHEET
Understanding genomics1
Genomics is the study of complex sets of genes, how they are expressed (what their level of activity is),
and the role they play in biology. Another way to think about it is as a small society of genes and how
they work together to influence tumor biology. The Human Genome Project has helped to identify and
sequence the full set of genes in the human body, and the work is ongoing to determine how various
genes affect treatment planning. Actionable insight comes from understanding how genes inter-relate
and what those resulting functions are, in addition to knowledge of their sequences or forms.
As the study of genomics advances, the application of genomic information is expected to enhance the
diagnosis, prognosis, and treatment of diseases, including cancer.
What is the difference between genomics and genetics?2
While genomics and genetics may sound similar and are related, each focuses on different information.
Broadly speaking, genetics is the study of how inherited traits are passed from one generation to the
next, through the genes, and how new traits appear by way of genetic mutations or changes. These
traits may be characteristics like eye or hair color.
A predisposition to certain types of diseases can also be passed through the genes. For example, the
gene for hereditary nonpolyposis colon cancer (HNPCC) is an inherited cancer syndrome. Individuals
with HNPCC have an increased risk of developing colon and rectal cancer, as well as other types of
cancer.
Genetic tests that screen for these inherited traits are different from the Oncotype DX Colon Cancer
Assay, which is a genomic test. A genomic test looks at groups of genes and how active they are. This
activity can influence whether a cancer is likely to recur in the future. Unlike a genetic test, the
Oncotype DX test does not provide information about a person’s inherited genetic make-up. Instead,
the Oncotype DX test looks at 12 genes in a patient’s colon tumor to understand how these genes
interact and function.
Genomics in cancer3
There is a tremendous need for new ways to manage and treat cancer, an extremely complex disease
family that accounts for one out of every four deaths in the United States.4 An individual cancer contains
many different alterations based on the unique biology of the patient’s disease. As a result, certain
patients may be more likely than others to develop advanced disease or to respond to certain therapies.
Because we have only limited insight into these differences at initial diagnosis, choosing a treatment
tailored to the individual is difficult.
This is where genomics – the study of complex sets of genes and how they work as a small society to
influence tumor biology – comes in. New genomic services are being developed to provide clinically
validated, individualized tumor profiles that may greatly improve the quality of treatment decisions for
patients with cancer, ultimately impacting patient outcomes.
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Applying genomics to cancer5
The application of genomics to cancer may seem straightforward, but the behavior of cancer is
dependent on many different genes, how they interact, and the conditions they create for disease to
occur.
Although it is possible to identify a single gene that may signal a more aggressive type of disease, by
analyzing a key set of genes that the tumor expresses we can gather far more specific and reliable
information. With genomics, it is possible to assess the unique biology of each patient’s cancer and to
predict the course of the disease for that individual. In turn, this knowledge makes it possible for
physicians and patients to help individualize a treatment plan, which can potentially improve patient
outcomes.
The key to effectively using genomics to improve cancer treatment and outcomes lies in determining
which sets of genes and gene interactions affect different subsets of cancers. Studies can be performed
to help us understand which patterns of gene expression within a tumor are linked to a response to
therapy or to the likelihood that the cancer will return or metastasize.
These results can then be used to develop clinically validated tests—such as Oncotype DX—that provide
the genomic profile of an individual’s tumor, allowing physicians to better understand whether patients
are likely to experience a recurrence of their cancer, which can help with treatment decision-making.
The field of genomics is a dynamic area of research. It is growing and evolving very quickly as more and
more researchers grasp the potential of this exciting branch of science. Ultimately, experts in the field
expect that genomics will play a role in each step of the cancer management process, as illustrated
below.
1.
2.
3.
4.
5.
Source: www.genomichealth.com/genomics/understanding.aspx
Source: www.mytreatmentdecision.com/320-genomics-vs-genetics.aspx
Source: www.genomichealth.com/genomics/default.aspx
Source: American Cancer Society, Inc.’s Cancer Statistics 2007
Source: www.genomichealth.com/genomics/applying.aspx
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RECURRENCE FACT SHEET
Understanding Colon Cancer Recurrence
Your healthcare team will make every effort to remove all traces of a colon tumor during surgery. Most
patients with early stage colon cancer never have a recurrence, but the disease may still recur (return or
spread) for some patients. A recurrence can happen months or years after the original colon cancer was
diagnosed and treated. The aggressiveness of the tumor and other factors can lead to the return or
spread of colon cancer in the future.
To reduce the likelihood of experiencing a recurrence, patients are often treated with chemotherapy,
which can reduce the risk for some patients that their cancer will return or spread. However,
chemotherapy may have short- and long-term side effects. For this reason, you and your healthcare
team should consider the risks and benefits of potential treatment to determine which option is best for
you.
What Does Recurrence Mean?
Simply put, recurrence is the return of the same type of cancer after initial treatment. Therapy for early
stage colon cancer is given with the goal of reducing the chance that cancer will return or recur in the
future. It is valuable to know how likely it is that your particular cancer will return because that may
help you and your doctor determine whether additional treatment beyond surgery is appropriate.
There are different types of recurrence:
Local and regional recurrence is the return of cancer to the area where you originally had surgery. Signs
of a local recurrence of colon cancer usually become apparent during follow-up surveillance, such as
colonoscopies.
Loco-regional recurrences are often treated similarly to the way the original cancer was: with surgery or
chemotherapy.
In distant recurrence, the cancer metastasizes, or spreads to parts of the body other than the colon or
lymph nodes located near the colon. If colon cancer metastasizes, it most commonly spreads to the liver
or lungs. Symptoms such as jaundice or abdominal swelling may be signs that the cancer has spread to
the liver.
Assessing Recurrence Risk
Traditionally, doctors have used colon cancer characteristics such as tumor size, tumor grade (based
upon examination by the pathologist), lymph node status, and patient age to estimate how likely colon
cancer is to come back, as well as to help determine treatment decisions.
These characteristics can be helpful in choosing a course of treatment; and if you are a patient who has
been diagnosed with stage II colon cancer, then the Oncotype DX® colon cancer test can provide
additional information to help you and your physician determine the likelihood that you will experience
a future recurrence.
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The Oncotype DX test determines how 12 specific genes are expressed (that is, their level of activity)
within a tumor sample. The measurement of these genes is combined into an individualized result
called a Recurrence Score®. The Recurrence Score result, which is a number between 0 and 100,
correlates with the likelihood that your colon cancer will return or metastasize within three years of
your initial diagnosis.
The lower the score is, the lower the chances are that your colon cancer will come back. And the higher
the score is, the greater the chances that colon cancer will come back. However, it is important to note
that a lower Recurrence Score result does not mean that there is no chance that a patient’s colon cancer
will return, and a higher score does not always mean that colon cancer will definitely return. The
Recurrence Score provides information about the likelihood of recurrence—it cannot determine with
certainty whether or not colon cancer will return.
Your Recurrence Score, together with the other diagnostic characteristics of your tumor, can help you
and your doctor make a decision about the treatment that is best for your individual disease.
Is Chemotherapy Right for Me?
If you are diagnosed with stage II colon cancer, your doctor may recommend surgery to remove the
tumor and any other cancerous tissue surrounding the tumor. One of the reasons why cancer is a
challenging disease to treat, however, is the possibility that it can come back, or recur, after the initial
treatment. This is why surgery is often followed by additional treatment, such as chemotherapy.
To determine the most appropriate treatment plan for you, you and your doctors should consider the
individual implications of various treatments. For example, you and your doctors should discuss a
treatment’s ability to reduce the likelihood that your colon cancer will return and compare that with the
likely side effects of each specific treatment.
As you are probably well aware, chemotherapy can treat colon cancer effectively, but it does have side
effects. Not all patients benefit equally from chemotherapy. In fact, studies have shown that on
average, approximately 3-4% of patients with stage II colon cancer derive a benefit from chemotherapy
(Lancet 370:2020, 2007).
Before deciding whether chemotherapy is right for you, you and your doctor should consider how likely
your colon cancer is to return. Understanding this can help provide you and your healthcare team with
insight into the best treatment for your individual disease.
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ADVOCATE RESOURCES
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SAMPLE NEWSLETTER ARTICLE
Cutting-Edge Genomic Technology Now Available to Help Stage II Colon Cancer Patients Make More
Informed Treatment Decisions
Thanks to advances in science and the development of many important therapies over the past decade,
colon cancer is a treatable disease, one that many people survive and move beyond to live long and
active lives. But for many newly diagnosed patients the question remains, is additional treatment
following surgery right for me?
Now, a new genomic test is available to help address this critical question for people who are newly
diagnosed with stage II colon cancer. The test, developed by Genomic Health® and called the Oncotype
DX® Colon Cancer Assay, analyzes the activity of 12 genes within a patient’s tumor to calculate an
individual Recurrence Score® result that predicts the likelihood of whether or not that patient’s cancer
will spread– or recur – within three years of the initial diagnosis. This information can help patients and
oncologists make more personalized treatment decisions based on the tumor’s specific biology.
Breakthrough Technology – How it Works
When colon cancer is discovered during a routine screening such as a colonoscopy, patients often
undergo surgery to remove the tumor. For patients with stage II colon cancer, their physicians can then
order the Oncotype DX test. This is done by having the pathologist at the hospital send a small sample
of the patient’s tumor tissue to the Genomic Health CLIA-certified, CAP-accredited reference laboratory
in California, where the Oncotype DX test is performed. The test uses RNA (ribonucleic acid) analysis of
tumor tissues to measure the expression of a pre-specified panel of 12 genes. Since the test uses a
specimen from the initial tumor sample that was removed during surgery, no additional surgery or
procedures are required for the test to be performed.
Based on results of the Oncotype DX assay, a Recurrence Score, which is a number between 0 and 100,
is generated. This specific number corresponds to the probability of that patient’s cancer recurring
within three years of diagnosis. This information, in turn, can assist stage II patients and their physicians
in making more tailored treatment plans, based on the patient’s individualized Recurrence Score. By
identifying patients with a lower risk of recurrence, the test may help physicians and their patients
decide to forego chemotherapy and lower both adverse effects and cost for these patients, while
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increasing patient confidence in their treatment selection. For more information about Oncotype DX,
please call 866-ONCOTYPE or visit www.oncotypedx.com or www.genomichealth.com.
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ONCOTYPE DX® FREQUENTLY ASKED QUESTIONS
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What is the Oncotype DX test?
How does the Oncotype DX test work?
When should the Oncotype DX test be used?
What are the benefits of the Oncotype DX test?
Is the Oncotype DX test right for me?
Can the Oncotype DX test be used for metastatic colon cancer?
How do I get the Oncotype DX test?
How long will it take to get the results of the Oncotype DX test?
How accurate are the results of the Oncotype DX test?
Does the Oncotype DX test provide the information I need to decide whether to receive
chemotherapy?
Will the Oncotype DX results tell my doctor which treatment to use?
What type of sample is needed to perform the Oncotype DX test?
How is the tumor sample submitted for Oncotype DX analysis?
How does Oncotype DX report the results?
Is the Oncotype DX test covered by insurance?
What if I don’t have insurance or am underinsured?
How do I qualify for the patient assistance program?
Does the Oncotype DX test replace other laboratory tests?
What is the difference between genetic tests and genomic tests?
Where can I learn more about the Oncotype DX test?
Questions & Answers:
Q: What is the Oncotype DX Colon Cancer Assay?
A: The Oncotype DX colon cancer test provides an individual, numerical assessment of how likely colon
cancer is to return for patients with stage II colon cancer following surgery to remove the tumor. The
Oncotype DX test examines the activity of 12 genes within a patient’s tumor sample in order to provide
quantitative and individualized information about the specific biological make-up of their colon cancer.
Q: How does the Oncotype DX test work?
A: RNA, part of the genomic makeup of your cells, is extracted from the tumor sample and then
analyzed to determine the level of activity – or expression – of each of 12 genes. The results of the
analysis are then put into a mathematical equation to convert those measurements into the Recurrence
Score® result. This result corresponds to the likelihood of colon cancer returning (metastasizing) within
three years of the patient’s initial diagnosis.
Q: When should the Oncotype DX test be used?
A: The Oncotype DX test is appropriate for people who are newly diagnosed with stage II colon cancer
following surgery. It is important to request this test prior to starting a chemotherapy treatment
regimen, since the Oncotype DX test can provide insight into the individual biology of each patient’s
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tumor, which in turn may help determine the most appropriate treatment for that individual’s colon
cancer. If you do not know the stage of your colon tumor, please check with your doctor and request a
copy of your pathology report.
The Oncotype DX test is performed on tumor tissue removed during the original surgery. Because of
this, the Oncotype DX test does not require any additional surgery or procedures in order for a patient
to get the test.
Q: What are the benefits of the Oncotype DX test?
A: The Oncotype DX test provides a Recurrence Score result that assigns a numerical value to the
likelihood that a patient’s colon cancer will return (metastasize) following surgery.
The test report provides information that improves confidence in treatment planning because it is based
on an understanding of each patient’s individual disease characteristics. This is important information
for both the treating physician and the patient diagnosed with colon cancer.
The test is designed for people who have been recently diagnosed with stage II colon cancer following
surgery. Patients with this type of cancer may wish to discuss the test with their physician.
Q: Is the Oncotype DX test right for me?
A: If you have recently been diagnosed with stage II colon cancer and have not yet begun a
chemotherapy treatment regimen, the Oncotype DX test may be appropriate for you. However, the
decision to use the Oncotype DX test is one that you and your doctor should discuss and make together.
Q: Can the Oncotype DX test be used for metastatic colon cancer?
A: No, the Oncotype DX test is not appropriate for people with metastatic colon cancer. The Oncotype
DX test is clinically validated for use in patients who have been newly diagnosed with stage II colon
cancer following surgery.
Q: How do I get the Oncotype DX test?
A: The Oncotype DX test can only be ordered by an authorized healthcare professional. It is a
noninvasive test performed on a small amount of the tissue removed during your original colon surgery.
This means you do not have to undergo any additional surgery or procedures to have the Oncotype DX
test.
Q: How long will it take to get the results of the Oncotype DX test?
A: It will typically take 10 to 14 calendar days from the date the tumor sample is received by Genomic
Health for the results to be available. The Oncotype DX report form is sent to both the doctor treating
you and the pathologist who submitted the tissue sample.
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Q: How accurate are the results of the Oncotype DX test?
A: The Oncotype DX test assigns a numerical value that indicates the likelihood that a patient’s colon
cancer will return or spread (metastasize). That numerical value—the Recurrence Score result—adds
information beyond traditional factors such as tumor size, tumor grade, and the patient’s age by looking
at the biological makeup of their tumor.
The lower the score is, the lower the chances are that your colon cancer will come back. And the higher
the score is, the greater the chances that colon cancer will come back. However, it is important to note
that a lower Recurrence Score result does not mean that there is no chance that a patient’s colon cancer
will return, and a higher score does not always mean that colon cancer will definitely return. The
Recurrence Score provides information about the likelihood of recurrence—it cannot determine with
certainty whether or not colon cancer will return.
Q: Does the Oncotype DX test provide the information I need to decide whether to receive
chemotherapy?
A: You and your doctor will work together to make this very personal decision, but the Oncotype DX test
is an important tool to consider using – together with other information – when deciding whether or not
to undergo chemotherapy. You and your doctor should consider the Oncotype DX test results together
with other findings, as well as your own personal preference, in determining which treatment plan is
right for you.
Q: Will the Oncotype DX results tell my doctor which treatment to use?
A: The results of Oncotype DX can help your doctor understand how likely – or unlikely – it is that your
cancer will return in the future, which can help with the treatment planning process. However, it is
important to note that the test will not specifically identify which treatments to use. Instead, the results
of the Oncotype DX test should be used with other diagnostic information to help you and your doctor
make a more informed treatment decision.
Q: What type of tumor sample is needed to perform the Oncotype DX test?
A: The Oncotype DX process is performed using a very small sample of the tumor tissue removed during
a patient’s colon surgery. This means that no additional surgery or procedures are needed for this test.
In the United States, tumor samples are commonly treated with a preservative called formalin and then
embedded in paraffin wax to form a small block. The Oncotype DX process is designed for use with a
small sample from this type of tissue block.
Q: How is the tumor sample submitted for Oncotype DX analysis?
A: Your doctor works with a pathologist, who is a specialist in diagnosis and tumor tissue analysis, to
prepare a tissue specimen from the tumor removed during surgery. The pathologist uses a special kit to
submit the tumor sample to the Genomic Health laboratory for analysis.
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Q: How does Oncotype DX report the results?
A: A detailed report is generated and sent to your healthcare provider, with your Recurrence Score
results. The Recurrence Score is a number between 1 and 100 that corresponds to a specific likelihood
that colon cancer will return – or metastasize – within three years of surgery to remove the tumor.
The lower the score is, the lower the chances are that your colon cancer will come back. And the higher
the score is, the greater the chances that colon cancer will come back. However, it is important to note
that a lower Recurrence Score result does not mean that there is no chance that a patient’s colon cancer
will return, and a higher score does not always mean that colon cancer will definitely return. The
Recurrence Score provides information about the likelihood of recurrence—it cannot determine with
certainty whether or not colon cancer will return.
Q: Is the Oncotype DX test covered by insurance?
A: Because the Oncotype DX Colon Assay is so new, we are currently working closely with insurers across
the country – including Medicare, Anthem Wellpoint, Aetna, CIGNA, Kaiser Permanente, and many
others – to secure reimbursement for the test, as part of our commitment to helping patients access the
important information that this test generates.
In addition, Genomic Health has created the Genomic Access Program (GAP) to support all patients in
navigating the insurance process. Specifically, we assist patients with benefits investigations to
determine whether their insurance covers the test. We also directly bill insurance plans on behalf of
insured patients in the United States whose physicians order the Oncotype DX test.
If an insurer requires a prior authorization before we can begin processing the patient’s tumor
specimen, our GAP team can also help facilitate that process. If a claim is denied on first review, our
team will appeal this denial on the patient’s behalf, with input from the patient’s physician as needed.
In those cases in which all appeals are exhausted and the claim is not fully paid, the patient may
ultimately be responsible for any balance remaining on the invoice. However, Genomic Health’s GAP
services include a patient assistance program to support eligible patients facing a financial hardship—
including both uninsured and underinsured patients.
Throughout the entire process, our reimbursement professionals will assist patients in their efforts to
obtain coverage for this test, and we encourage you to contact GAP if you have questions by calling
(866) ONCOTYPE, (866-662-6897).
Q: What if I don’t have insurance or am underinsured?
A: Genomic Health believes that every eligible patient should have access to the Oncotype DX colon
cancer test, so the company offers a patient assistance program, including:
 Financial assistance for qualifying un- and under-insured patients
 Assistance with balances due (if eligible for the program)
 Payment plans to meet your financial situation
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Q: How do I qualify for the patient assistance program?
A: Genomic Health understands that being responsible for some or all of the costs associated with the
Oncotype DX test may be a financial burden. The company offers patient assistance program to assist
with this burden, which takes into account your income and financial obligations such as house or rental
payments, car payments, children’s education, medical expenses, and other qualifying expenses. For
more information, contact Genomic Health’s Customer Service at (866) ONCOTYPE, (866-662-6897).
Q: Does the Oncotype DX test replace other laboratory tests?
A: No. The results of the Oncotype DX test are intended to be used together with the results of other
laboratory tests that are performed to evaluate colon cancer.
Q: What is the difference between genetic tests and genomic tests?
A: Genetic tests look at an individual’s inherited genes. Genomic tests look at groups of genes and how
active they are. The Oncotype DX test looks at a group of 12 genes and their activity in colon tumor
tissue. This activity can influence how colon cancer is likely to grow and respond to treatment. The
Oncotype DX test does not provide information about an individual’s inherited genetic makeup. It
provides information about the genomic activity of the tumor.
Q: Where can I learn more about the Oncotype DX test?
A: To learn more about the Oncotype DX test, talk to your healthcare professional and care team. You
can also call 866-ONCOTYPE or visit www.oncotypedx.com or www.genomichealth.com.
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GLOSSARY
Adenocarcinoma: A cancerous tumor that arises in or resembles glandular tissue.
Adjunct agent: In cancer therapy, a drug or substance used in addition to the primary therapy.
Adjuvant chemotherapy: A term used to describe the role of chemotherapy relative to other cancer
treatments. It is typically given alone or with radiation after surgical resection.
Adjuvant radiation therapy: The use of radiation after treatment in order to prevent a cancer from
recurring.
Anaplastic: A term used to describe cancer cells that divide rapidly and have little or no resemblance to
normal cells.
Anastomosis: The joining together of two ends of healthy bowel after diseased bowel has been cut out
(resected) by the surgeon. This may be contrasted to a colostomy, when the bowel ends may be
permanently diverted, or anastamosed at a later surgery.
Archived Tumor Sample: A tumor sample that has been routinely preserved and stored. Tumor tissue is
commonly preserved for storage by being treated with a preservative called formalin and then
embedded in paraffin (wax).
Antigen: A substance that is recognized by the body as being foreign and, as such, can trigger an
immune response.
Barium enema: A barium enema is a series of x-rays of the lower gastrointestinal tract. The barium
enema procedure consists of the insertion of barium (a radiolucent solution) to coat the lower
gastrointestinal tract. The barium coats the lower gastrointestinal tract and x-rays are taken. On X-ray,
areas in which the barium “lights up” may indicate abnormal cell proliferation. This procedure is also
called a lower GI series.
Biopsy: The removal and examination of a sample of tissue from a living body for diagnostic purposes; to
take a sample (a biopsy) for pathological examination.
Cancer: A condition in which abnormal cells divide without control. Cancer cells can also invade nearby
tissues and can spread through the bloodstream and lymphatic system to other parts of the body.
Cancer staging: The process of assigning a descriptor (usually numbers I to IV) of how much a cancer has
spread in the body. Criteria for staging include: size of tumor, amount of tissue penetration, whether it
has invaded adjacent organs, how many lymph nodes it has metastasized to (if any), and whether it has
spread to distant parts of the body. (See also TNM Classification of Malignant Tumors; Dukes Staging
System).
Carcinoma: Any malignant cancer that comes from epithelial cells. Carcinomas will invade surrounding
tissue, and have the propensity to metastasize to the lymph nodes and beyond.
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Carcinoma in situ: Epithelial tumor cells confined to the tissue of origin, without invasion through the
basement membrane.
Chemotherapy: The treatment of disease by chemical agents. Usually, but not always, chemotherapy
refers to treatment of cancer.
Chromosome: A microscopically visible carrier of genetic information.
Clinical Trial: A research study to test drugs, procedures, or testing technologies to determine whether
these are effective and/or safe.
Colectomy: Surgical resection of all or part of the colon (also called the large intestine).
Colitis: inflammation of the colon. Colitis has many forms including ulcerative, Crohn's, infectious,
pseudomembranous, and spastic.
Colon polyp: A fleshy growth on the inside (the lining) of the colon.
Colonoscopy: Inspection through a fiber-optic scope of the inside of the colon.
Colorectal: Related to the colon and/or rectum.
Diagnosis: Identification of a condition, such as colon cancer, by its signs and symptoms, and the results
of laboratory tests or other examinations.
Distant Recurrence: The spread of cancer to parts of the body other than the place where the cancer
first occurred, also known as metastasizing. In colon cancer, the cancer typically spreads to the liver or
lungs.
Dukes staging system: A system of staging rectal cancers developed by Cuthbert Duke in 1932. The
original system had 3 stages but has been modified over time to include four stages with variations on
two of the four stages.
Dysplasia: A term that refers to abnormal cells that have the potential to progress to cancer.
Endoscope: A long slender medical instrument for examining the interior of a bodily organ or
performing minor surgery.
Endoscopy: Visual examination of a bodily orifice, canal or organ using an endoscope.
Gastroenterologist: a physician who specializes in diseases of the gastrointestinal tract.
Gastroenterology: The branch of medicine that focuses on the digestive system and its disorders.
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Gene: The functional and physical units of inheritance that are passed from parents to their offspring.
The genes found in normal colon tissue can change their “expression” (see below), which can give rise to
colon cancer.
Gene Expression: The level of activity of a gene or group of genes.
Gene Expression Profile: A picture of the activity or expression of multiple genes from a single
specimen, such as a tumor sample.
Genetics: The study of how inherited traits are passed from one generation to the next through the
genes, and how new traits appear by way of genetic mutations or changes. These traits may be
characteristics like eye or hair color.
Genome: The complete genetic material of a living thing.
Genomic test: A test that looks at groups of genes and how active they are. This activity can influence
how a cancer is likely to grow and respond to treatment.
Genomics: The study of complex sets of genes, how they are expressed in cells (what their level of
activity is), and the role they play in biology.
Hand Foot Syndrome (Palmar-Plantar Erythrodysesthesia): Also called hand-foot syndrome or hand-tofoot syndrome, Palmar-Plantar Erythrodysesthesia is a side effect, which can occur with several types of
chemotherapy or biologic therapy drugs used to treat cancer. Leakage of the drug through the
capillaries of the skin of the hands and feet can cause redness, tenderness, and peeling of the skin of the
palms and soles.
Hereditary nonpolyposis colon cancer (HNPCC): An inherited cancer syndrome. Individuals with HNPCC
have an increased risk of developing colon and rectal cancer, as well as other types of cancer.
Local Recurrence: The reappearance of cancer in the part of the body where it first occurred.
Malignant: Tending to be severe and become progressively worse; a malignant tumor is one that has
the ability to invade and destroy nearby tissue and/or spread (metastasize) to other parts of the body.
Metastasis: The process by which cancer spreads from an initial tumor to distant locations in the body.
When cancer cells spread and form a new tumor in a different organ, the new tumor is a metastatic
tumor. The cells in the metastatic tumor come from the original tumor.
Newly Diagnosed: A term used to describe colon cancer that has recently been identified.
Oncotype DX® Colon Cancer Assay: A unique diagnostic test for patients with stage II colon cancer that
looks at the genomic profile of a colon tumor to predict the likelihood of recurrence within three years
of surgery to remove the tumor.
Oncologist: A physician who specializes in the study and treatment of tumors.
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Oncology: The branch of medicine concerned with the study and treatment of tumors.
Pathologist: Physician who identifies diseases by studying cells and tissues under a microscope.
Pathology Report: A report ordered by authorized healthcare professionals that describes what was
found in tissue removed from the body after the tumor and surrounding tissue are checked by a
pathologist. Usually includes information on tumor grade and stage.
Polyethylene glycol: An electrolyte-based laxative solution used to clean the bowel before a
gastrointestinal exam.
Polyp: A usually nonmalignant growth or tumor protruding from the mucous lining of an organ, such as
the colon. Colon polyps are fleshy growths that occur on the inside (the lining) of the large intestine.
Predispose: To make more likely or render susceptible.
Radiation Therapy: 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.
Recurrence: A return of cancer after treatment. This can be either local (at the site of the original
tumor), or distant (beyond the original site).
Resection: Surgery to remove a cancer and some surrounding tissue.
Sarcoma: A malignant tumor growing from connective tissues, such as cartilage, fat, muscle, or bone.
Screening: Looking for masses or suspicious areas in colon tissue on a periodic basis.
Sigmoidoscopy: Inspection through a fiber-optic scope of the inside of the sigmoid colon, which is part
of the large intestine that empties into the rectum. The test is useful for diagnosing the cause of
diarrhea, constipation, or abdominal pain, and for identifying cancerous tissue.
Staging: (See cancer staging).
Synchronous cancer: Multiple primary cancers occurring simultaneously.
Syndrome: A set of signs and symptoms that tend to occur together and which reflect the presence of a
particular disease or an increased chance of developing a particular disease.
Surveillance/Follow-Up: An ongoing assessment by the medical team, once treatment has been
completed, to assess the cancer's remission and to look for any evidence of a cancer’s return.
TNM Classification of Malignant Tumors (TNM): A cancer staging system that describes the extent of
cancer in a patient’s body. TNM literally describes Tumor/Nodes/Metastasis. T describes the size of the
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tumor and whether it has invaded nearby tissue, N describes the number of regional lymph nodes that
are involved, and M describes the presence of other metastases. This system is jointly maintained by
the International Union Against Cancer (UICC), and the American Joint Committee on Cancer.
Treatment Monitoring: An ongoing and frequent assessment by the medical team, during the time of
treatment, to monitor how the patient is tolerating the treatment and how the cancer is responding.
Tumor: Tissue growth where the cells that make up the tissue have multiplied uncontrollably. A tumor
can be benign (non-cancerous) or malignant (cancerous).
Tumor Grade: The characterization of a tumor based on how similar in appearance the cancer cells are
to normal cells, and on how many of those tumor cells are dividing. Tumor grade is one of many factors
that, when used in combination, can indicate how aggressive someone's cancer is.
Ulcerative colitis: A disease where sores, or ulcers, form in the top layers of the lining of the large
intestine. Inflammation usually occurs in the lower part of the colon and rectum.
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