Trial Design

TORISEL—studied in a predominantly poor-risk patient population
 

TORISEL is the only approved advanced RCC treatment with pivotal phase 3 trial results in a predominantly poor-risk patient population

Based on a MEDLINE® literature review of published data from US trials as of April 2015.
 
 

Randomization

Patient randomization in the phase 3, multicenter, open-label study1,2

The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety.
 
Patients were stratified by geographic region and nephrectomy status.
 
Treatment with the combination of TORISEL 15 mg and IFNα was associated with an increase of multiple adverse reactions and did not result in a significant increase in OS when compared with IFNα alone.1
 
 
 
 
 

Risk factors

*KPS of 60 indicates the patient requires occasional assistance, but is able to care for most of his or her needs. KPS of 70 indicates the patient cares for himself or herself, but is unable to carry on normal activity or do active work. The KPS risk factor based on published MSKCC data is KPS <80.3
 
 
 
 

Disease characteristics

Includes patients with indeterminate, non-clear-cell, and unknown histologies.
 
 
REFERENCES
  1. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-2281.
  2. Data on file. Pfizer Inc, New York, NY.
  3. Motzer RJ, Bacik J, Murphy BA, et al. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002;20(1):289-296.