Facts About Kidney Cancer

Kidney cancer currently affects more than 36,000 people in the United States. Although kidney cancer was first reported in 1826, scientists have not yet conclusively determined its cause. Kidney cancer occurs in almost twice as many men as women, and most often develops after the age of 40. However, the disease has been seen in children as young as six months old.

Kidney Cancer Risk Factors

People are at a higher risk of developing cancer if they have certain characteristics called risk factors. A risk factor is any trait or behavior that increases the chance of developing a disease. Some of the risk factors for kidney cancer include:

Family History: People with a family history of kidney cancer are nearly four times more likely to develop the disease.

Von Hippel-Lindau (VHL) syndrome: VHL is a very rare illness that runs in some families. People with VHL are predisposed to develop renal cell carcinoma. They may also develop cancers of the brain, spinal cord, pancreas, adrenal gland, and eye. Through genetic testing, the VHL gene mutation can now be detected.

Smoking: Cigarette smoking may account for as much as one fourth of all cases and is a major risk factor for kidney cancer. Cigar smoking may also increase risk.

Obesity: Research shows that obesity may increase the chance of developing kidney cancer, particularly in women.

Hemodialysis: kidney cancer is more common among patients receiving long-term hemodialysis. Hemodialysis is performed on patients whose kidneys function inadequately. The dialysis machine acts as an artificial kidney and is used to clear the blood in the way that a healthy, functioning kidney normally would.

Occupation: Certain types of occupations appear to increase the risk for kidney cancer, especially if the job requires contact with certain chemicals or substances. For example, iron- and steelworkers who are exposed to coke ovens, and workers consistently exposed to asbestos or cadmium may have a higher risk for kidney cancer.

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PROLEUKIN (aldesleukin) is indicated for the treatment of adults with metastatic
renal cell carcinoma and metastatic melanoma.

Important Safety Information

Therapy with PROLEUKIN^® (aldesleukin) for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

PROLEUKIN^® should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

PROLEUKIN^® administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone, and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

PROLEUKIN^® treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of PROLEUKIN^® therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

PROLEUKIN^® administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

IMPORTANT Side Effect Information

In clinical studies, the following life-threatening side effects were seen in >1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: decreased urine (6%), stopping of all urine (5%), low blood pressure (3%), breathing problems (3%), abnormal blood test (high bilirubin) for how the liver works (2%), coma (2%), diarrhea (2%), too many acid chemicals in the blood (1%), sudden kidney failure (1%), stopping breathing (1%), heart problems (1%), clotting problems (1%), confusion (1%), abnormal blood test (high creatinine) for how the kidney works (1%), shortness of breath (1%), fever (1%), heart attack (1%), infection (1%), severe mental illness (1%), infection in the blood (1%), abnormal blood test (high SGOT) for how the liver works (1%), severe sleepiness (1%), fast heartbeat (2%), low blood platelet count increasing the chance of bleeding (1%), and vomiting (1%).

From the same studies, the following side effects (Grades 1-4, meaning from mild to severe) were seen in >30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: low blood pressure (71%), diarrhea (67%), decreased urine (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), abnormal blood test (high bilirubin) for how the liver works (40%), low blood platelet count increasing the chance of bleeding (37%), nausea (35%), confusion (34%), and abnormal blood test (high creatinine) for how the kidney works (33%).

In patients receiving PROLEUKINin these studies (255 with metastatic renal cell carcinoma and 270 with metastatic melanoma), 4% (11/255) of patients with metastatic renal cell cancer and 2% (6/270) of patients with metastatic melanoma died from treatment-related side effects of PROLEUKIN.

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