Your Health

New Information For The Treatment Of GIST, A Rare, Life-Threatening Cancer

Posted: 9/7/2011

Scientists strive to help patients with KIT+ GIST.

(NAPSI)—According to a national survey, nearly one in three patients with rare cancers-twice the number as those with more common cancers—say they received multiple diagnoses when their cancer was first discovered.

Gastrointestinal stromal tumors, or GIST, are a rare, life-threatening cancer of the gastrointestinal tract that impact approximately 6,000 people in the U.S. The major cause of GIST is an abnormal form of the protein KIT, which causes cells to grow uncontrollably and become cancerous. GIST, like other rare forms of cancer, are often difficult for physicians to diagnose and to treat because they may not cause any physical symptoms.

“Accurate diagnosis for patients with GIST can be challenging,” says Christopher Corless, M.D., Ph.D., professor of pathology at Oregon Health & Science University. “It involves the expertise of a multidisciplinary health care team, including a primary care physician, pathologist, oncologist and surgeon. This core team of medical professionals is critical for patients not only during their diagnosis, but more importantly, during the course of their treatment.”

In the past, even with the correct medical team in place, patients diagnosed with GIST had limited effective medical options. This was a frightening reality for many patients and their loved ones, since nearly half of all people with GIST are at risk of having their tumors grow back or turn into metastatic disease following the original surgical removal.

Gleevec® (imatinib mesylate)* tablets has since revolutionized medical treatment for KIT+ GIST, significantly decreasing the likelihood of recurrence of GIST after surgery. Gleevec is the only drug approved to treat patients after surgical removal of their primary KIT+ GIST (adjuvant therapy).

Today, scientists continue to strive to help patients by making advances in the current standard of care. Recently, new data was presented at the American Society of Clinical Oncology (ASCO) annual meeting showing that extending the duration of Gleevec treatment after surgery may keep patients’ tumors away longer and may help extend their overall survival.

“After I was diagnosed with GIST, I did research and learned that there was a high likelihood that even after surgical removal the tumor would grow back,” said Sherri Janousky, a GIST patient. “When my oncologist told me about the potential to take Gleevec post-surgery, I did even more research and started treatment.”

For helpful resources on GIST, visit www.myGISTcircle.com or www.Gleevec.com, and speak with a health care professional or advocacy group to learn more.

*Known as Glivec® (imatinib) outside the United States, Canada and Israel.

About Gleevec

Gleevec® (imatinib mesylate) tablets are indicated for the treatment of patients with KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) that are cancerous, cannot be surgically removed and/or have spread to other parts of the body and use after surgery in patients that have had their KIT+ GISTs completely removed. Approval is based on survival without a return of cancer (recurrence-free survival) with a median follow-up of 14 months. Clinical benefit has not been demonstrated by a long-term effect on recurrence-free survival or survival.

Gleevec Important Safety Information

Gleevec can cause fetal harm when administered to a pregnant woman. Women should not become pregnant and should be advised of the potential risk to the unborn child.

Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.

Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec. Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.

Long-term use may result in potential liver, kidney and/or heart toxicities; immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.

Cases of tumor lysis syndrome, which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases.

Almost all patients with KIT+ GIST treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist first, including Tylenol® (acetaminophen); herbal products (St. John’s wort, Hypericum perforatum); Coumadin® (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin® (phenytoin). Taking these with Gleevec may affect how they work, or affect how Gleevec works.

You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how Gleevec works.

Please see full Prescribing Information.

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