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Queens Chronicle

Taking Care in Sunny Weather: Answers To Important Questions About Metastatic Melanoma

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Posted: Friday, August 29, 2014 1:00 am | Updated: 4:35 am, Fri Sep 5, 2014.

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(BPT) - With sunshine and warm weather upon many of us, it’s a particularly important time to familiarize yourself with metastatic melanoma, the most dangerous form of skin cancer. Here are answers to some frequently asked questions about the disease.

What is melanoma?

Melanoma is a form of skin cancer in which cells that produce the skin’s pigment grow out of control. It can occur anywhere on the skin, but is most commonly found on the chest and back of men, and on the legs of women. It is also commonly found on the face and neck of both genders.

Melanoma is most difficult to treat when it spreads beyond the surface of the skin to other organs, such as the lymph nodes, lungs, or brain. This is called metastatic melanoma.

What is the incidence of metastatic melanoma?

According to the Melanoma Research Alliance, the largest private funder of melanoma research, more than 76,000 new cases of melanoma are diagnosed in the United States annually. Of the new cases of melanoma expected in the U.S. this year, approximately 3,000 will be diagnosed as metastatic disease. Additionally, roughly 20 percent of all early-stage melanoma patients eventually develop metastatic melanoma.

What is the prognosis for metastatic melanoma patients?

Metastatic melanoma is the deadliest form of skin cancer and is one of the most aggressive forms of cancer. Historically, the average survival rate of patients with metastatic melanoma has been approximately six to nine months. However, over the last few years, additional treatments have been approved that may help patients.

What is the treatment for metastatic melanoma?

While a metastatic melanoma diagnosis can be overwhelming, it is important that patients discuss treatment options with their medical team.

“After I was diagnosed with metastatic melanoma, my doctor reviewed the available treatments with me. We also discussed my treatment goals, which was one of the most important conversations we’ve had throughout this experience,” said John Barnosky of Hamilton, NJ. “After weighing all options, we decided Yervoy® was the most appropriate treatment for me.”

Yervoy, also known as ipilimumab, is one treatment option for metastatic melanoma. It is approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with melanoma that has spread (metastatic) or cannot be removed through surgery (unresectable). Yervoy does not kill melanoma directly. It is thought to boost the body's immune system. It will not work in all patients and may affect healthy cells too, which could result in serious side effects in many parts of the body. Some of these side effects may lead to death.

Clinical trial results have shown that some Yervoy patients lived longer than patients who did not receive Yervoy.

In a phase III clinical trial, an estimated 46 percent of patients taking Yervoy alone were alive at one year versus 25 percent of patients taking an experimental drug alone. At two years, 24 percent of patients taking Yervoy (ipilimumab) alone were alive versus 14 percent taking an experimental drug alone. Patients treated with Yervoy lived a median of 10 months compared to a median of six months for those who were treated with an experimental drug alone.

Of the 676 patients in this trial, 137 patients (20 percent) received Yervoy alone, 136 patients (20 percent) received another experimental drug alone, and 403 patients (60 percent) received both treatments. In the trial, patients were previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin. The primary goal was to measure how long patients lived with Yervoy in combination with the experimental drug compared to the experimental drug alone. The study results showed that treatment with Yervoy decreased the risk of death by about one third compared to patients who received the experimental drug. Individual results will vary. It is important to ask your doctor if Yervoy is right for you.

The serious side effects of Yervoy may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes. In addition to the serious side effects, the most common side effects of Yervoy are tiredness, diarrhea, itching, and rash.

These side effects are most likely to begin during treatment; however, side effects can show up months after the last infusion. Healthcare providers should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with Yervoy. The oncologist may decide to delay or stop Yervoy.

Patients should call their healthcare provider if they have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Patients should not try to treat symptoms themselves.

These are not all of the possible side effects of Yervoy. Please see the Important Safety Information below for additional information.

Talk to your healthcare provider about any questions you may have about your health or Yervoy. To learn more, visit www.yervoy.com.

Important Safety Information

Yervoy (ipilimumab) can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes.

These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with Yervoy. Your oncologist may decide to delay or stop Yervoy.

Call your healthcare provider if you have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Do not try to treat symptoms yourself.

Serious side effects may include:

  • Inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:
    • diarrhea (loose stools) or more bowel movements than usual
    • blood in your stools or dark, tarry, sticky stools
    • stomach pain (abdominal pain) or tenderness
  • Inflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:
    • yellowing of your skin or the whites of your eyes
    • dark urine (tea colored)
    • nausea or vomiting
    • pain on the right side of your stomach
    • bleeding or bruise more easily than normal
  • Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:
    • skin rash with or without itching
    • sores in your mouth
    • your skin blisters and/or peels
  • Inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:
    • unusual weakness of legs, arms, or face
    • numbness or tingling in hands or feet
  • Inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:
    • persistent or unusual headaches
    • unusual sluggishness, feeling cold all the time, or weight gain
    • changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
    • dizziness or fainting
  • Inflammation of the eyes. Symptoms may include:
    • blurry vision, double vision, or other vision problems
    • eye pain or redness

Pregnancy and Nursing:

  • Tell your healthcare provider if you are pregnant or plan to become pregnant. Yervoy (ipilimumab) may cause stillbirth, premature delivery, and/or death of your unborn baby. Before starting Yervoy, tell your healthcare provider if you are breast-feeding. It is advised that nursing mothers do not breast feed while taking Yervoy.

Tell your healthcare provider about:

  • Your health problems if you:
    • have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn's disease, lupus, or sarcoidosis.
    • had an organ transplant, such as a kidney transplant
    • have liver damage from diseases or drugs
    • have any other medical conditions
  • All the medicines you take including:
    • all prescription and non-prescription medicines
    • steroids or other medicines that lower your immune response
    • vitamins
    • herbal supplements

You should not start a new medicine before you talk with your healthcare provider who prescribes you Yervoy.

Most Common Side Effects:

The most common side effects of Yervoy include: tiredness, diarrhea, itching, and rash.

These are not all of the possible side effects of Yervoy (ipilimumab). If you have any questions about your health or medicines, talk to your healthcare provider.

Please visit www.yervoy.com for U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for Yervoy.

Brought to you by Bristol-Myers Squibb Company

YERVOY® and the related logo are trademarks of Bristol-Myers Squibb Company

© 2014 Bristol-Myers Squibb Company

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