Patient Types
TORISEL is a mammalian target of rapamycin (mTOR) inhibitor indicated for the treatment of advanced renal cell carcinoma (RCC)1
TORISEL was specifically studied as a first-line treatment of advanced RCC in patients with multiple prognostic risk factors.1
Patients with advanced RCC were eligible for the Global Advanced Renal Cell Carcinoma (ARCC) Study, a phase 3 pivotal trial, if they presented with 3 or more of the following preselected prognostic risk factors:
- Karnofsky performance status of 60 or 70
- > 1 metastatic organ site of disease
- Hemoglobin less than the lower limit of normal
- < 1 year from time of initial RCC diagnosis to randomization
- Corrected calcium > 10 mg/dL
- Lactate dehydrogenase > 1.5 times the upper limit of normal
Most patients (94%) had ≥ 3 of 6 prognostic risk factors at randomization.2
Median overall survival with TORISEL for patients with multiple risk factors was 10.9 months
(95% CI, 8.6, 12.7), compared with 7.3 months (6.1, 8.8) with interferon-alpha (P=0.0078) (Hazard Ratio [95% CI]=0.73 [0.58, 0.92]).1 Read
more about TORISEL Efficacy.
The median duration of treatment in the TORISEL arm was 17 weeks (range 1-126 weeks)
The median duration of treatment in the IFN-α arm was 8 weeks (range 1-124 weeks)
TORISEL was studied in previously untreated patients with advanced RCC who had clear-cell or non-clear-cell tumor histologies1
Overall survival results were achieved with TORISEL in patients regardless of clear-cell or non-clear-cell tumor histology.3
The different types of RCC histologies and their incidence in RCC patients4:

Used with permission from Linehan WM, Walther MM, Zbar B. The genetic basis of cancer of the kidney. J Urol. 2003;170:2163-2172.
For more information on prognostic risk factors, read the Journal of Clinical Oncology article, Validation and Extension of the Memorial Sloan-Kettering Prognostic Factors Model for Survival in Patients With Previously Untreated Metastatic Renal Cell Carcinoma.
For more information on appropriate candidates for different types of kidney cancer treatment, visit the National Comprehensive Cancer Network (NCCN) Web site and click on "NCCN Clinical Practice Guidelines in Oncology™."
TORISEL as 1st- and 2nd-Line
Treatment Option
NCCN recommends TORISEL as a first-
and second-line treatment option in
advanced RCC.5
References:
- TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.
- Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma.
N Engl J Med. 2007;356:2271-2281. - Data on file, Wyeth Pharmaceuticals Inc.
- Linehan WM, Walther MM, Zbar B. The genetic basis of cancer of the kidney. J Urol. 2003;170:2163-2172.
- National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: kidney cancer. V.1.2009.
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