Non-Small Cell Lung Cancer
Pancreatic Cancer
Metastatic Breast Cancer
Ovarian Cancer
About GEMZAR
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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, and includes each stage's 5-year rate of survival:

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 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.

  • 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.

References:

  1. American Cancer Society. What is Ovarian Cancer? Available at: http://www.cancer.org/docroot/CRI/content/….
    Accessed March 3, 2008.
  2. American Cancer Society. How Many Women Get Ovarian Cancer? Available at: http://www.cancer.org/docroot/CRI/content/….
    Accessed March 3, 2008.
  3. American Cancer Society. How Is Ovarian Cancer Staged? Available at: http://www.cancer.org/docroot/CRI/content/….
    Accessed March 3, 2008.
  4. American Cancer Society. Chemotherapy. Available at: http://www.cancer.org/docroot/CRI/content/….
    Accessed April 14, 2008.


About GEMZAR

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

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

GEMZAR in combination with paclitaxel is approved by the FDA 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 indicated 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).

Important Safety Information

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to be pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. 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, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

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 test and on your general condition.

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

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