Trial Design

TORISEL—studied in a predominantly poor-risk patient population
 

TORISEL is approved for the treatment of advanced RCC

Most patients had poor prognostic risk in the TORISEL phase 3 Global ARCC study (N=626).1
 

Randomization

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

torisel-trialdesign-randomization

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

*Karnofsky performance status (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 Memorial Sloan Kettering Cancer Center 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. Oken MM, Creech R, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.