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Study Results & Design

Learn how TORISEL may help you.

TORISEL was studied in a large clinical trial. Patients in this study had advanced renal cell carcinoma (RCC). They had not been treated with medications for advanced RCC before the study. The study compared TORISEL to a treatment called interferon-alpha.

Study results

The median overall survival for patients who got TORISEL was 49% higher than for those who got interferon-alpha (IFNα). This means patients who received TORISEL lived longer on average than patients who received IFNα. While TORISEL has been shown to extend survival, it is not a cure for advanced RCC.
 

Median overall survival in patients who got TORISEL compared to patients who got IFNα

Median overall survival was 10.9 months in the TORISEL group. It was 7.3 months in the IFNα group. This means:

  • Half the patients in the TORISEL group lived longer than 10.9 months and half lived less than 10.9 months
  • Half the patients in the IFNα group lived longer than 7.3 months and half lived less than 7.3 months

Patients in the study stayed on the treatments for different amounts of time:

  • In the TORISEL group, half of the patients stayed on treatment for less than 17 weeks and half stayed on longer
  • In the IFNα group, half of the patients stayed on treatment for less than 8 weeks and half stayed on longer


The most common side effects with TORISEL (occurring in 30% or more of patients) were:

  • Rash
  • Weakness/fatigue
  • Mouth sores
  • Nausea
  • Swelling/fluid retention
  • Loss of appetite

Learn more about TORISEL Side Effects.

Study design

The study randomly divided 626 patients with advanced RCC into 3 groups:

  • 207 were assigned to get just IFNα
  • 209 were assigned to get just TORISEL
  • 210 were assigned to get both IFNα and TORISEL
    • Patients who got both treatments were more likely to have severe side effects. Patients in this group did not have better median overall survival compared with patients who got just IFNα

The groups were similar in terms of age, gender, and race:

  • The average age of the patients was 59 years
  • 69% of the patients were men, and 31% were women
  • 91% of the patients were white, and 9% were of other racial backgrounds

Risk factors

Patients included in the TORISEL study were expected to have a shorter survival than most advanced RCC patients. In order to enroll, patients were required to have at least 3 of the following 6 preselected prognostic risk factors:

  • Karnofsky performance status of 60 or 70. This means the patients:
    • Were able to live at home and care for most of their personal needs
    • Needed some assistance and were not able to work
  • More than 1 metastatic organ site of disease. This means the cancer had spread to more than 1 organ outside the kidney
  • Hemoglobin less than the lower limit of normal. This means the patients had a low number of blood cells that carry oxygen. This condition is called anemia
  • Less than 1 year from the time of initial RCC diagnosis to the start of the study
  • Corrected calcium greater than 10 mg/dL
  • LDH greater than 1.5 times the upper limit of normal

Talk to your health care provider about risk factors and how they relate to treatment options.


Learn how TORISEL may help you.

clinical trial: a study that looks at how effective a new treatment is in patients

immunotherapy: treatment that helps the body's immune system fight cancer cells

median overall survival: the number of months or years of life from the time of diagnosis that marks a mid-point. Half the patients in the study survived longer than this number. Half survived for a shorter period of time.

fatigue: tiredness

prognostic risk factors: factors that reflect how serious a disease is. They can help determine a prognosis.

prognosis: a prediction about the outcome of a disease

corrected calcium: a measurement of calcium in the blood. In RCC patients, high corrected calcium may indicate that the cancer is growing or spreading fast.

LDH: a substance in the blood called lactate dehydrogenase. In RCC patients, high LDH may indicate that the cancer is growing or spreading fast.

Indication

Scroll for Important Safety Information and 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 healthcare 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.
  • Patients taking TORISEL may require monitoring for protein in their urine and kidney problems and should contact their healthcare provider for signs and symptoms of kidney problems. If there is too much protein in your urine, your healthcare provider may tell you to stop taking TORISEL.
  • 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 also be at risk for Pneumocystis jiroveci pneumonia (PJP), a fungal infection in the lungs. Fatal cases have been reported. This may be related to the use of TORISEL along with corticosteroids or other medications that suppress the immune system.
  • 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 an effective 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.
  • Do not breastfeed during treatment with TORISEL and for 3 weeks after the last dose.
  • TORISEL may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you.
  • 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


Call your doctor for medical advice about side effects. You are encouraged to report
adverse events related to Pfizer products by calling 1-800-438-1985. If you prefer, you
may contact the U.S. Food and Drug Administration (FDA) directly. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.


Please see the full Prescribing Information for TORISEL.

   
 
 

Important Safety Information

Scroll for Important Safety Information and Indication.
  • 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 also be at risk for Pneumocystis jiroveci pneumonia (PJP), a fungal infection in the lungs. Fatal cases have been reported. This may be related to the use of TORISEL along with corticosteroids or other medications that suppress the immune system.
  • 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

Please see the full Prescribing Information for TORISEL.


Indication

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


Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.