SASKATCHEWAN CANCER AGENCY

Effective immediately, Temsirolimus (Torisel®) will be funded by the Saskatchewan Cancer Agency for first line treatment of metastatic renal cell carcinoma (mRCC) in patients with clear cell histology and poor prognostic risk criteria, or non-clear cell histology.  In this patient population, Temsirolimus increased overall survival by a median of 3.6 months as compared to Interferon (10.9 months vs. 7.3 months, HR=0.73; 95% CI of 0.58 to 0.92; p=0.008). 

Temsirolimus is administered as a 30 to 60 minute infusion once weekly until disease progression or unacceptable toxicity.  Temsirolimus will be considered a hazardous drug and safe handling procedures, including use of PhaSeal, will be required.  At this time, Temsirolimus is not approved for infusion in COPS centers.

Only one line of targeted therapy is funded for mRCC.  Patients whose disease progresses on Temsirolimus are not eligible for SCA funded treatment with another targeted treatment, such as Sunitinib or Sorafenib.  Alternatively, patients whose disease progresses on Sunitinib are not eligible for SCA funded treatment with Temsirolimus or Sorafenib.

Determination of risk group for mRCC requires baseline information and tests to be available in the SCA chart as noted below.  Poor prognosis risk grouping for mRCC is defined as having 3 or more of the following risk factors:

1.      LDH greater than 1.5 times the upper limit of normal

2.      Hemoglobin less than the lower limit of normal

3.      Corrected calcium greater than the upper limit of normal

4.      Time from diagnosis to first treatment less than 1 year

5.       Karnofsky performance status less than 70 (equivalent to ECOG performance score greater than or equal to 3)

6.      Multiple organ sites of metastasis