About Advanced RCC

If you or someone you love has been diagnosed with kidney cancer, you are not alone.

Here are some facts about the numbers of people affected by this serious disease:

• In the U.S., kidney cancer is the seventh most common cancer in men. In women, it is the eighth most common.
• In the U.S. in 2010, about 35,370 new cases of kidney cancer were diagnosed in men. About 22,870 were diagnosed in women.
• Kidney cancer made up 3% to 4% of all new cancers diagnosed in the U.S. in 2010.
• Kidney cancer caused about 13,000 deaths in the U.S. in 2010.
• Renal cell carcinoma (RCC) is the most common type of kidney cancer. Over 90% of kidney cancers are of this type.

Advanced RCC

Despite surgery, in about 20% to 30% of patients, cancer will return. And of those diagnosed with RCC, about 11% already have advanced (metastatic) disease at diagnosis. So when you are diagnosed with RCC, you may need other treatment, not just surgery to remove the tumor. TORISEL is approved to treat the portion of patients whose cancer is advanced.

Signs & symptoms of RCC

More than half of all cases of RCC are found by chance. This happens when you get an imaging test for a different health issue. You may not have any obvious signs or symptoms of RCC.

Some common signs and symptoms of RCC include:

• Fatigue
• Weight loss
• Anemia
• Blood in the urine
• Pain in the lower side of the torso

Risk factors for RCC

Men have a higher risk than women of developing RCC. Most people who are diagnosed are in their 60s or 70s.
Other risk factors are:

• Smoking
• Obesity
• High blood pressure
• Certain types of kidney disease

Stages of RCC

Staging overview and 5-year survival rates for kidney cancer

Stage I: Tumor is 7 centimeters (about 3 inches) or smaller and found only in the kidney. 5-year survival: 96%

Stage II: Tumor is larger than 7 centimeters and found only in the kidney. 5-year survival: 82%

Stage III: Tumors/cancerous tissue can be found in the kidney, an adrenal gland, a nearby lymph node, the tissue around the kidney, or major blood vessels of the kidneys. 5-year survival: 64%

Stage IV: Tumors/cancerous tissue can be found in other areas of the body outside the fatty tissue surrounding the kidney, such as the intestines, lymph nodes, pancreas, lungs, or other organs. 5-year survival: 23%

Adapted from Cohen et al.
© 2005, Massachusetts Medical Society. All rights reserved.

Note: images shown for relative comparison; not actual size.

When RCC is found at an early-stage, it can be treated with surgery to remove the tumor. Part or all of the kidney may also be removed.

Treatment for RCC

The main treatment for early-stage RCC is surgery to remove the cancer from the body.

Types of surgery for RCC include:

• Nephrectomy (pronounced: nuh-FREK-tuh-mee) – kidney removal. This type of surgery is done for early-stage RCC and some cases of advanced RCC.
• Partial nephrectomy – removing part of the kidney. This type of surgery is done if the tumor is less than 4 centimeters (about 1.5 inches) in diameter. It might also be done if you have only one kidney or if there are tumors in both kidneys. Another reason would be if the kidneys are not working right.
• Laparoscopic nephrectomy – removing part or all of the kidney with a method called laparoscopy. With this method, the surgeon does not have to open the abdomen but makes small cuts to get the kidney out.
• Ablation – a technique to kill tumor cells using radio waves or extreme cold. This is done on tumors that are less than 3 centimeters (about 1.2 inches) in diameter. It is also done if a person cannot have major surgery.

Chemotherapy and radiation, used to treat other cancers, are not generally used for treating RCC.

Other types of treatment for advanced RCC may include:

• Immunotherapies – These help the immune system fight the cancer.
• Molecular therapies – These are designed to block growth or spread of cancer cells.

Researchers are also looking at other treatments for RCC. These include vaccines, stem-cell therapies, and others.

Indication

TORISEL is indicated for the treatment of advanced renal cell carcinoma.

Important Safety Information

• You should not receive TORISEL if certain tests show that your liver function is moderately or severely impaired. TORISEL should be used with caution in patients whose liver function is mildly impaired and should be given at a reduced dose.
• TORISEL can cause serious side effects. If you experience side effects that are too severe to tolerate, your health care professional may choose to delay your treatment, give you a lower dose of TORISEL, or discontinue treatment.
• Before you begin treatment with TORISEL, your doctor may give you an antihistamine. It is possible to have a serious (including a life-threatening or fatal) allergic reaction even after you receive an antihistamine. Tell your doctor or nurse if you are allergic to antihistamines or are unable to take antihistamines for any other medical reasons. Tell your doctor or nurse if you have any swelling around your face or trouble breathing during or after treatment with TORISEL.
• Patients are likely to experience increased blood sugar levels. This may require treatment with or an increase in the dose of a medicine that lowers blood sugar levels. Tell your doctor or nurse if you are thirstier than usual or urinate more often than usual.
• Patients are likely to experience an increase in cholesterol and/or triglycerides. This may require treatment with or an increase in the dose of a medicine that lowers cholesterol and/or triglycerides.
• Before you begin treatment with TORISEL, tell your doctor or nurse about ALL MEDICINES you are taking, including
• Prescription medications, including but not limited to antibiotics, anticonvulsants, antidepressants, antifungals, antivirals, blood pressure medications, blood thinners, dexamethasone, vaccines
• Nonprescription (over the counter) medications
• Vitamins
• Herbal supplements, including but not limited to St. John’s Wort
• Avoid eating grapefruit or drinking grapefruit juice during the course of your treatment with TORISEL, including the time between treatments, as they may change the amount of TORISEL in your body.
• Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.
• Patients may get chronic inflammation of the lungs during treatment with TORISEL. Rare fatal cases have been reported. Tell your doctor or nurse right away if you have any trouble breathing, or develop a cough or fever.
• TORISEL may cause bowel perforation. Fatal cases have been reported. Tell your doctor or nurse right away if you have any new or worsening stomach pain or blood in your stool.
• Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.
• During treatment with TORISEL, wounds may not heal properly. Tell your doctor or nurse if you are recovering from surgery or have an unhealed wound. Tell your doctor or nurse if you plan to have surgery during treatment with TORISEL.
• TORISEL may increase the risk of bleeding in the brain, which has, in some cases, been fatal. You are at increased risk if
• You have a central nervous system tumor, such as a brain tumor
• You are taking medicine to keep your blood from clotting
• Some vaccines may be less effective when given during the course of treatment with TORISEL. You should avoid the use of live vaccines and close contact with people who have recently received live vaccines. Ask your doctor or nurse if you are eligible to receive a flu shot.
• Both men and women should use a reliable form of birth control during treatment and for 3 months after the last dose of TORISEL. TORISEL can harm an unborn baby. Tell your doctor or nurse before beginning treatment if you are pregnant or thinking of becoming pregnant.
• Elderly patients may be more likely to experience certain side effects including diarrhea, edema and pneumonia.
• The most common side effects are
  • Rash
  • Weakness/fatigue
  • Mouth sores
  • Nausea
  • Swelling/fluid retention
  • Loss of appetite

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