TORISEL Study Results
& Design

TORISEL was studied in a large clinical trial. Patients in this study had advanced renal cell carcinoma (RCC). They had not been treated with medication for advanced RCC before the study. The study compared TORISEL to a treatment called interferon-alpha. Interferon-alpha is a type of immunotherapy. For more information on study design, click here

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.

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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