Overview of Advanced Renal Cell Carcinoma (RCC)

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Renal Cell Carcinoma

If you or someone you love has been diagnosed with RCC, you are not alone. Here are some facts reflecting the numbers of people who are affected by this serious disease:

  • In the United States, kidney and renal pelvis cancer is the seventh most common cancer in men and the ninth most common cancer in women.21[3A -- ACS, p. 10]
  • In 2008, an estimated 33,130 new cases of kidney and renal pelvis cancer were expected to be diagnosed in men and 21,260 in women in the United States.21[3A -- ACS, p. 10]
  • Kidney and renal pelvis cancer account for 3% to 4% of all new cancers that were expected to be diagnosed in the United States in 2008.21[3A -- ACS, p. 10]
  • Over the past 30 years, there has been a 3% increase every year in the number of cases of RCC diagnosed in the United States.32[4A -- Feldman, p. 1] The cause of these increases is uncertain.32[4A -- Feldman, p. 1]
  • Kidney and renal pelvis cancer was expected to cause about 13,000 deaths in the United States in 2008.21[3B -- ACS, p. 4]

Signs & Symptoms of RCC

About half of all cases of RCC are now found by chance when a person gets an imaging test (a test that takes pictures of the inside of the body) for a different health issue.43[2B -- Cohen, p. 2477] In these cases, the person might not have any noticeable signs or symptoms of RCC.

Some common signs and symptoms of the disease include43[2B -- Cohen, p. 2477]:

  • Fatigue
  • Weight loss
  • Anemia (not enough red blood cells)
  • Blood in the urine
  • Pain in the lower side of the torso

Risk Factors for RCC

Men have a higher risk than women for getting RCC. Most people diagnosed with RCC are in their 60s or 70s.43[2B -- Cohen, p. 2477]

Other risk factors are43[2B -- Cohen, p. 2477]:

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

Stages of RCC

Staging Overview and Five-Year Survival Rates for Renal Cancer4-63-5[2I -- Cohen, p. 2478]

Five-year survival rates for renal cancer and staging overviewFive-year survival rates for renal cancer and staging overview

Five-year survival data based on the 1997 tumor-node-metastasis (TNM) staging guidelines.

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


When RCC is detected at an early stage (before it has spread beyond the place where it first started), it can be treated successfully with surgery to remove the tumor and part or all of the kidney.76[5A -- Keane, p. 375]

Advanced Renal Cell Carcinoma

Despite surgery, in about 33% of patients, cancer will return.3,42,3 And of the people who are diagnosed with RCC, about 25% to 30% already have advanced disease when they are diagnosed, which means the cancer has spread beyond the place where it first started.3,42,3[4B -- Feldman, p. 1; 2A -- Cohen, p. 2477]

For these reasons, many people diagnosed with RCC may need other types of treatment, beyond the surgery to remove the tumor.

Important Safety Information

  • Before you begin treatment with TORISEL, your doctor may give you an antihistamine. It is possible to have a serious 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 difficulty breathing during or after treatment.
  • TORISEL can cause serious side effects. The most common side effects are
    • Rash
    • Weakness/fatigue
    • Mouth sores
    • Nausea
    • Swelling/fluid retention
    • Loss of appetite
  • 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.
  • 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, 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.

Please see Important Safety Information continued on the next page.
  • Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.



    Please see Important Safety Information continued on the next page.

    Please see accompanying full Prescribing Information.

  • 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, get a cough, or develop a fever.
  • TORISEL may cause bowel perforation. Rare 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 or still have an unhealed wound from surgery. 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 rare 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.


Please see the full Prescribing Information for TORISEL.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


References:

  1. TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.
  2. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin. 2008;58:71-96.
  3. Feldman DR, Motzer RJ. Novel targets and therapies for metastatic renal cell carcinoma. Oncology. 2006;20:1745-1753.
  4. Cohen HT, McGovern FJ. Renal-cell carcinoma. N Engl J Med. 2005;353:2477-2490.
  5. Kidney. In: Greene FL, Page DL, Fleming ID, et al, eds. AJCC Cancer Staging Manual. 6th ed. New York, NY: Springer; 2002:323-328.
  6. Linehan WM, Bates SE, Yang JC. Cancers of the genitourinary system. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1139-1168.
  7. Keane T, Gillatt D, Evans CP, et al. Current and future trends in the treatment of renal cancer. Eur Urol Suppl. 2007;6:374-384.

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TORISEL Clinical Trial

TORISEL has been proven to extend survival longer than interferon-alpha (another therapy) in patients with advanced RCC.1 [1A -- PI, p. 20]

Learn more about the effectiveness shown in the TORISEL Clinical Trial.

Learn more about TORISEL Side Effects.