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Bladder CancerAnswers to commonlyasked questions

Helpful questions to guide discussions with

your doctor

It is important for you to have honest, open discussions withyour cancer care team. They want to answer all of your questions, no matter how minor you might think they are. Some questions to consider:

• What type of bladder cancer do I have?

• Do you think my cancer has spread beyond the bladder?

• What is the stage and grade of my cancer, and what does that mean in my case?

• Are there other tests that need to be done before we can decide on treatment?

• Are there other doctors I need to see?

• How much experience do you have treating this type of cancer?

• What are my treatment options?

• What do you recommend and why?

• What is the goal of the treatment?

• What are the chances my cancer can be cured with these options?

• What are the risks or side effects that I should expect? How long are they likely to last?

• If my bladder is removed, what are my options for urinary diversion? What are the pros and cons of each?

• How quickly do we need to decide on treatment?

• What should I do to prepare for treatment?

• Should I follow a special diet?

• How long will treatment last? What will it involve? Where will itbe done?

• What would we do if the treatment doesn’t work or if thecancer recurs?

• What type of follow-up will I need after treatment?

>> http://www.cancer.org/Cancer/BladderCancer/DetailedGuide/ bladder-cancer-talking-with-doctor

References:

American Cancer Society – Cancer.org

National Cancer Institure – Cancer.gov

Genetics Home Reference – National Institute of Health

For additional information:

www.abbottmolecular.com

What is bladder cancer?

Bladder cancer is a disease in which certain cells in the

bladder become abnormal and multiply without control

or order. This buildup of extra cells often forms a mass of

tissue called a growth or tumor. Tumors in the bladder can

be benign (not cancer) or malignant (cancer). Most bladder

cancers develop in the urothelium (inner layer of the bladder),

however, some can grow into deeper layers. If bladder

cancer grows through these layers into the wall of the

bladder, it becomes more diffi cult to treat.

In the United States, bladder cancer is the fourth most common type of cancer in men and the ninth most common cancer in women. About 45,000 men and 17,000 women are diagnosed with bladder cancer each year.

In general, bladder cancer is a treatable disease but highly recurrent. This means that there is a chance of cancer returning (50%-75%). Early diagnosis is associated with better results from treatment options and a greater chance of permanent remission. Ongoing monitoring and accurate detection of disease recurrence are key to improvingsurvival rates for bladder cancer.

Late diagnosis of bladder cancer leads to a delay in treatment. Patients treated at later stages and gradesare associated with lower success rates for remissionand survival.

>> http://www.cancer.org/Cancer/BladderCancer/DetailedGuide/bladder-cancer-what-is-bladder-cancer

>> http://www.cancer.gov/cancertopics/wyntk/bladder/page3

>> http://ghr.nlm.nih.gov/condition/bladder-cancer

What causes bladder cancer?

When patients are diagnosed with bladder cancer, it’s natural for them to wonder what may have caused the disease. Unfortunately, doctors can’t always explain why one person gets bladder cancer and another doesn’t.

However, we do know that people with certain risk factors may be more likely than others to develop bladder cancer. A risk factor is something that may increase the chance of getting a disease. It is important to know about risk factors for bladder cancer because there may be things you can do to lower your risk of getting it. If you are at higher risk because of certain factors, you may benefi t from tests that might help fi nd it early, when treatment is most likely tobe effective.

Risk factors associated with the

development of bladder cancer

Smoking: It is the greatest risk factor for bladder cancer. Smokers are twice as likely to develop bladder cancer as non-smokers.

Chemicals in the workplace: Chemicals have also been linked with the development of bladder cancer. Industries where workers are exposed to carcinogens (a substance that produces cancer) carry the highest risk. This includes manufacturers of dye, rubber and leather, textiles printers,and painters. Other workers at risk include hairdressersand truck drivers.

Race: Whites are twice as likely to develop bladder canceras blacks and Hispanics. Asians have the lower risk of developing the disease.

Age: The risk of developing bladder cancer increases withage. Over 70% of people with bladder cancer are above 65 years old.

Gender: Men are diagnosed more often than women (3:1).

Personal or family history of bladder cancer: People who have had bladder cancer have an increased risk of getting the disease again. Having a family member with bladder cancer can slightly increase the risk of developing the disease.

>> http://www.cancer.org/Cancer/BladderCancer/DetailedGuide/bladder-cancer-risk-factors

>> http://www.cancer.gov/cancertopics/wyntk/bladder/page4

What signs or symptoms are associated with

bladder cancer?

The most common sign of bladder cancer is painless gross hematuria, visible blood in the urine. This important sign is sometimes ignored which can lead to a delay in diagnosis. It is ignored for two main reasons: 1) the bleeding may be occasional and short-lived. 2) There is likely to be no pain associated with the bleeding. It is important to note that blood in the urine isn’t always associated with bladder cancer. Other symptoms include irritation when urinating and urgency, frequency and a constant need to urinate. It is important to see a physician immediately in the presence of these symptoms.

>> http://www.cancer.gov/cancertopics/wyntk/bladder/page5

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How is bladder cancer diagnosed?

If you have symptoms that suggest bladder cancer, your doctor will try to fi nd out what’s causing the problems.

You may have a physical exam. Also, you may have oneor more of the following tests:

Urine tests which may be associated with bladder cancer or other underlying conditions: Urine tests are used in combination with other tests and procedures as aids to diagnose bladder cancer and other urologic disorders. Initially, the lab checks your urine for hematuria (blood). The UroVysion Bladder Cancer Kit is a molecular test that detects genetic abnormalities within cells of the bladder. These abnormalities are known to be associated with bladder cancer. Urine Cytology is a test that is used to look for abnormal cells in the urine that are known to be associated with bladder cancer.

Cystoscopy: Your doctor uses a thin, lighted tube(a cystoscope) to look directly into your bladder. It may be done at your doctor’s offi ce. This test can be uncomfortable because the doctor will insert the cystoscope into thebladder through your urethra. You may need local anesthesia for this test.

Biopsy: Your doctor can remove samples of tissue with the cystoscope. A pathologist then examines the tissue under a microscope. The removal of tissue to look for cancer cells is called a biopsy. In most cases, a biopsy is the only sure wayto tell whether cancer is present.

For a small number of patients, the doctor removes the entire area with cancer during the biopsy. For these patients, bladder cancer is diagnosed and treated at the same time.

How is bladder cancer treated?

Treatment options for people with bladder cancer are surgery, chemotherapy, biological therapy, and radiation therapy. You may receive more than one type of treatment.

The treatment that’s right for you depends mainly onthe following:

• The location of the tumor in the bladder

• Whether the tumor has invaded the muscle layer or tissues outside the bladder

• Whether the tumor has spread to other parts of the body

• The grade of the tumor

• Your age and general health

You may have a team of specialists to help plan your treatment. Your doctor may refer you to a specialist, or you may ask for a referral. You may want to see a urologist (a surgeon who specializes in treating problems in the urinary tract). Other specialists who treat bladder cancer include urologic oncologists (surgeons who specialize in cancers of the urinary tract), medical oncologists, and radiation oncologists.

Your health care team may also include an oncology nurse and a registered dietitian. If your treatment involves surgery to remove the bladder, a wound, ostomy and continence nurse may also be part of your team.

Your health care team can describe your treatment choices, the expected results of each, and the possible side effects.You and your health care team can work together to developa treatment plan that meets your needs.

>> http://www.cancer.gov/cancertopics/wyntk/bladder/page8

Stages ofbladder cancer

Stage 0

The cancer cells are found only on the surface of the inner lining of the bladder. The doctor may call this carcinoma in situ.

Stage I

The tumor has grown deeper into the inner liningof the bladder. But it hasn’t invaded the muscle layer of the bladder.

Stage II

The tumor has invaded the muscle layer of the bladder.

Stage III

The tumor has grown through the muscle layer to reach tissues near the bladder, such as the prostate, uterus, or vagina.

Stage IV

The tumor has invaded the wall of the pelvis or abdomen, but cancer is not found in any lymph nodes. Or, the cancer cells have spread to at least one lymph node or to parts of the body far away

from the bladder, such as the liver, lungs, or bones.

Staging

If bladder cancer is diagnosed, your doctor needs to learn the extent (stage) of the disease to help you choose the best treatment.

Staging is a careful attempt to fi nd out the following:

• Whether the tumor has invaded the muscle layer of the bladder

• Whether the tumor has invaded nearby tissues

• Whether the cancer has spread, andif so, to what parts of the body

Grade

If cancer cells are found in the tissue sample from the bladder, the pathologist studies the sample under a microscopeto learn the grade of the tumor. The grade tells how much the tumor tissue differs from normal bladder tissue.It may suggest how fast the tumor islikely to grow.

Tumors with higher grades tend togrow faster than those with lower grades. They are also more likely to spread. Doctors use tumor grade along with other factors to suggest treatment options.

>>>> http://www.cancer.gov/cancertopics/wyntk/bladder/page6

Intended use

The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, and 17, and loss of the 9p21 locus via fl uorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria, and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Caution

United States Federal law restricts this device to sale and distribution to, or on the order of, a physician or a clinical laboratory; use is restricted to, by, or on the order of a physician.

Warnings and limitations

1. The UroVysion Kit has been optimized for identifying andquantitating chromosomes 3, 7, and 17, and locus 9p21 in human urine specimens.

2. The performance of the UroVysion Kit was validated using the procedures provided in the package insert only. Modifi cations to these procedures may alter the performance of the assay.

3. The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.

4. UroVysion assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate, e.g.,the presence of excessive granulocytes or massive bacteruria.

5. Technologists performing the UroVysion signal enumeration must be capable of visually distinguishing between the red and green signals.

6. Positive UroVysion results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract related cancers, e.g., ureter, urethra, renal, and/or prostate in males, and further patient follow-up is justifi ed. In a study conducted on patients with hematuria, 3 patients whose initial bladder cystoscopy

was negative, were subsequently diagnosed with renal cancer within 6 months of this initial study visit. All 3 of these cases were positive by UroVysion.

7. If UroVysion results are negative but standard clinical or diagnostic tests (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the UroVysion test. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.

8. Ta stage solitary tumors smaller than 5mm could not be detected by UroVysion FISH. UroVysion FISH results are dependent on the amount of tumor cells that are deposited on the slide.

Stage 0Stage 0

Stage IStage I

Stage IIStage II

Stage IIIStage III

Stage IVStage IV

MuscleMuscle

LiningLining

FatFat

UrethraUrethra

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