The Importance Of Sticking To Treatment

Tuesday, March 1, 2005

(NAPSA)—Patients have new weapons in the battle against cancer. Targeted therapies have opened new lines of attack, providing cancer patients with innovative treatment options to combat their disease. Unlike “traditional” forms of cancer treatment, targeted therapies interfere specifically with the signals that cause certain cancer cells to proliferate uncontrollably, and areless likely to affect normal functioningcells. According to a recent survey released by Novartis Oncology*, the large majority of cancer patients (88 percent) and nearly all physicians (100 percent) and nurses (97 percent) believe that there have been manypositive developments in the fight against cancerin the pastfive years *. These advances have also given many a greater sense of personal responsibility when it comes to managing their disease and medication regimen. At 38, Marina Symecox, a biochemist and Ph.D., had been diagnosed with a life-threatening cancer of the gastrointestinal tract called gastrointestinal stromal tumor, or GIST. After conventional therapy failed, Marina was beginning to lose the battle as her disease progressed. Her prognosis was bleak. Symcox consulted with several specialists and as a last-hope Tips To Help You Adhere To Your Treatment Regimen Take medications at the sametime as a normal daily routine. Set alarmsto remind youto take medication. Use a pillbox to organize your medications and to notity you if you have missed doses. Leave remindernotesin visible locations, such as on a mirror. effort enrolled in a clinical trial for an innovative therapy with the investigational name STI571, now called Gleevec (imatinib mesylate) Tablets. Gleevec, one of the first molecularly targeted cancer therapies, inhibits the activity of Kit, a protein that drives the growth of most GISTs. “Over four and a half years later, I’m still taking Gleevec and know the importance of taking my medication every day as prescribed by my doctor,” Symcox says. Unlike conventional cancer treatments, which are typically administered by a health care professional, therapies such as Gleevec are oral medications and the responsibility is on the patients to take their pills as prescribed by their doctors. Like Marina, many cancer patients use oral medications to treat their cancer or its related side effects. While many take extra steps to help them remember to take their prescription, approximately 70 percent of patients surveyed indicated that they have forgotten to take their medication on occasion,’ and about one-third (34 percent) admit that they have not taken their oral medication exactly as prescribed by their health care provider’. “Education plays a key role. Patients who are more informed about their illness and treatment regimen are morelikely to take their medications as prescribed,” states Denise Nurse Practitioner, Reinke, APRN, BC, AOCN, University of Michigan Comprehensive Cancer Center. It is important to consult with your health care provider about any concerns you may have with your medications. If you have difficulty remembering to take your medication or miss several doses, your physician or pharmacist may be able to simplify your treatment regimen or suggest ways to make it easier for you to remember to take your medications. * Harris Interactive conducted the survey online for Novartis Oncology between Oct. 7-20, 2004 among 433 U.S. adults (aged 18+) diagnosed with cancer. Sampling error for the overall sample results is +/- 5 percentage points. About Gleevec Tablets Gleevec is indicated for the treatment of patients with Kit (CD117)—positive unresectable and/or metastatic malignant GIST. The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Important Safety Information about Gleevec Tablets Severe (NCI Grades 3/4) lab abnormalities (400mg /day; 600mg /day)—including neutropenia (6%; 9%), anemia (8%; 5%) and hepatotoxicity (8%; 4%)—and severe adverse experiences (NCI Grades 3/4), including fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (6%; 3%), hemorrhage (5%; 8%) and musculoskeletal pain (3%; 0%) were reported among Gleevec patients. Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, increased intracranial pressure, and papilledema. Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have also been reported. In some cases, the reaction recurred upon rechallenge. Several postmarketing cases note a resolution or improvement of bullous reaction following dose reduction with or without supportive care. Some patients (5%) were reported to have severe GI bleeds or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds. Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse events, or hematologic adverse events. Therapy with Gleevec was discontinued for adverse events in 8% ofpatients at both dose levels. Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6 and CYP2C9. Examples of commonly used drugs that may significantly interact with Gleevec include acetaminophen, warfarin, erythromycin and phenytoin. Dosage of Gleevec tablets should increase by at least 50% and clinical response should be carefully monitored in patients receiving Gleevec tablets with a potent CYP3A4 inducer such as rifampin or phenytoin. (Please see full prescribing information for other potential drug interactions.) For daily dosing of 800mg and above, dosing should be accomplished using the 400mg tablet to reduce exposure to iron. Patients at a total dose of 1200mg daily may have an increased susceptibility to excess iron. If routine blood sampling indicates sustained increases in iron levels, attempts to lower other sources of iron exposure should be undertaken. Use of Gleevec tablets is contraindicated in patients with hypersensitivity to imatinib or to any other component of Gleevec tablets. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec tablets. Because of the potential for serious adverse reactions in nursing infants, women should be advised to avoid breast-feeding while taking Gleevec tablets. Common Side Effects of Gleevec Tablets: The majority of patients who received Gleevec in the clinical study experienced adverse events at some time. Most adverse events were mild to moderate in severity. The most frequently reported adverse events (all Grades, 400mg /day; 600mg / day) were superficial edema (71%; 76%), diarrhea (56%; 60%), nausea (58%; 56%), fatigue (83%; 38%), muscle cramps (80%; 41%), abdominal pain (37%; 37%), rash (26%; 38%), vomiting (22%; 23%), musculoskeletal pain (19%; 11%) and hemorrhage (18%; 19%). Supportive care may help the management of most mild to moderate adverse events so that the prescribed dose can be maintained whenever possible. Gleevec tablets should be taken with food and a large glass of water to minimize gastrointestinal (GD irritation. Gleevec tablets should not be taken with grapefruit juice. ? Harris Interactive survey for Novartis Oncology. Cancer and Quality of Life: Executive Summary, slide 7. ? Harris Interactive survey for Novartis Oncology. Cancer and Quality of Life: Executive Summary, slide 14. * Harris Interactive survey for Novartis Oncology. Cancer and Quality of Life: Executive Summary, slide 13.

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