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
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:
- Mouth sores
- Swelling/fluid retention
- Loss of appetite
Learn more about TORISEL Side Effects
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.
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
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.
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.