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  • Types of Ovarian Cancer
  • Diagnosis and Staging
  • How GEMZAR Can Help
  • Side Effects
  • Frequently Asked Questions
Ovarian Cancer
Important Safety Information
Prescribing Information
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Diagnosis and Staging

"Diagnosis" is what your healthcare team does to recognize whether or not you have ovarian cancer, based on its outward signs, symptoms, and diagnostic tests. "Staging" is a description of how far the cancer has spread, described as stages I through IV.

Both the diagnosis and staging of ovarian cancer is a multistep process that is required in order for you and your healthcare team to make decisions about treatment.

Diagnostic Tests
Staging
Your Healthcare Team
Treatment Options

Diagnostic Tests
The sooner ovarian cancer is diagnosed and treated, the better a woman's chance for survival. If ovarian cancer is suspected, several tests are utilized to make sure the diagnosis is right.

  • Vaginal-rectal pelvic examination
    This exam involves feeling the uterus and ovaries for abnormalities in shape or size.1 The doctor simultaneously inserts a finger in the vagina and one in the rectum. Most early-stage cancers are still not detectable with this technique, but it is commonly used to screen for ovarian cancer.1
  • Ultrasound
    Uses sound waves to create an image of internal organs. On this image, healthy tissue, unusual growths, and cancer appear different.2 Ultrasound may be done from the abdomen, passing an instrument over the outside of the abdomen, or from within the vagina (transvaginal ultrasound).1 While this technique can detect advanced ovarian cancers, it has low accuracy for detecting ovarian cancer in its early stages.
  • CA-125 blood test
    CA-125 is a protein that is produced by some abnormal ovarian cells and can be detected in a blood sample. The majority of women with advanced ovarian cancer have a high CA-125.1 The test is therefore useful for diagnosing and monitoring response during treatment and follow-up.

    However, some non-cancerous tumors also may cause high CA-125 levels and some ovarian cancers do not raise CA-125, including early-stage disease.1 Furthermore, pre-menopausal women may have an elevated CA-125 as a result of other conditions, such as pregnancy, endometriosis, uterine fibroids, liver disease, and benign ovarian cysts.
  • Biopsy
    The only way to tell for certain if a growth in the pelvis is cancer involves removing a small sample of tissue or fluid to see if cancer cells are present. This is called a "biopsy" and is often done at the time of surgery. It can also be done as a test separate from the surgery, such as during a "laparoscopy."2

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Staging
Following a diagnosis of cancer, the most important step toward receiving the best treatment is to have the stage of cancer accurately determined. The stage refers to the extent of the cancer — its size, its location, and whether it has spread beyond the ovaries.

The stage of cancer helps determine the treatment strategy. Cancer stages are described by a numerical values between stage I (the least advanced) and stage IV (the most advanced). The following table describes the four basic stages of ovarian cancer.

 

The above stages can be further classified into sub-groups. Ask your healthcare team to explain the exact stage of your cancer in terms you can understand.

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Your Healthcare Team
Ovarian cancer is a serious disease that is usually treated by a team of healthcare professionals with different specialties. Members of a healthcare team might include a surgeon, gynecologic
oncologist, medical oncologist, radiologist, pathologist, oncology nurse and social worker, among others. Not everyone with ovarian cancer should receive the same treatment. Your particular medical situation will determine the type of treatment you receive.

Each person's journey with cancer is different. Your own experience will depend on the stage of the cancer and other factors such as your general state of health and your treatment goals. You should talk openly with your healthcare team about your cancer stage and prognosis, and how they affect your treatment options.

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Treatment Options
Treatment options for ovarian cancer typically include surgery and chemotherapy. The goal of surgery is to remove as much of the cancer as possible. However, depending on the stage of the cancer, some cancer cells may remain after surgery.

Chemotherapy is any treatment involving the use of drugs to kill cancer cells. Cancer chemotherapy may consist of single drugs or combinations of drugs. It can be given through a vein, injected into a body cavity, or delivered orally in the form of a pill. Chemotherapy is different from surgery in that the cancer-fighting drugs circulate in the blood to parts of the body where the cancer may have spread; it can kill or eliminate cancer cells at sites far from the original cancer.4

The initial treatment of ovarian cancer is called "first-line" therapy. If the cancer continues to grow with first-line therapy or returns after first-line therapy, additional treatment, called "second-line" therapy, may be given. If the tumor continues to grow after second-line therapy, the next therapy is called third-line therapy, and so on. GEMZAR is indicated in combination with carboplatin for the 2nd-line treatment of ovarian cancer only.

  • First-Line Chemotherapy
    First-line chemotherapy for ovarian cancer typically consists of two drugs given together. The combination many women receive is
    paclitaxel given with a platinum drug — either carboplatin or cisplatin. Select women may benefit from administration of chemotherapy directly into the abdomen — called intraperitoneal therapy — in addition to conventional intravenous administration.
  • Second-Line Chemotherapy
    Second-line chemotherapy is additional treatment for women whose cancers have progressed or come back after first-line chemotherapy. The choice of drugs for second-line therapy depends largely on the side effects associated with the first-line treatment and how long it has been since the first-line therapy was stopped. Your healthcare team will walk through these decision points with you, but you should know that there are several chemotherapy drugs approved by the Food and Drug Administration (FDA) for the treatment of ovarian cancer that has returned.

Clinical trials have been performed and reviewed by the FDA on each of these options to determine their effectiveness and safety. As you and your healthcare team consider options for cancer treatment, it is important to carefully consider the results of clinical trials and the side effects of all available therapies.

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Now let's explore how GEMZAR can help.

Indications and Important Safety Information for GEMZAR

GEMZAR is approved by the FDA in combination with carboplatin (another type of chemotherapy) for the patient with advanced ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

GEMZAR is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.

GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

GEMZAR is approved by the FDA as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor because you should not receive it.

GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.

You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia, contact your healthcare team, as these can be symptoms of low blood cell counts.

Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems.

There have been reports of serious kidney or liver damage including failure with GEMZAR treatment, sometimes fatal. If you have had kidney or liver problems or impairment, please tell your healthcare team. GEMZAR may not be right for you.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood tests and on your general condition.

If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team.

Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea; vomiting; constipation; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. Lab work may identify additional side effects. If you have any side effect that bothers you or that does not go away, be sure to talk with your doctor. Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.

If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. The safety and effectiveness of GEMZAR in children has not been established.

For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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