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Published on: November 8, 2015
Temsirolimus: a safety and efficacy review
1Cleveland Clinic Taussig Cancer Center, Cleveland, OH 44195, USA. bukow464@sbcglobal.net
Expert Opinion on Drug Safety
|August 7, 2012
Summary
Temsirolimus significantly improves overall survival and progression-free survival in advanced renal cell carcinoma (RCC) patients with poor prognosis. This mTOR inhibitor is now a standard treatment for this patient group.
Area of Science:
- Oncology
- Pharmacology
Background:
- Renal cell carcinoma (RCC) treatment frequently targets the vascular endothelial growth factor (VEGF) pathway and mammalian Target of Rapamycin (mTOR).
- Temsirolimus, an mTOR inhibitor and derivative of sirolimus, offers improved stability and solubility for pharmaceutical use.
- The temsirolimus-FKBP-12 complex inhibits mTOR activity.
Purpose of the Study:
- To review the clinical efficacy and safety of temsirolimus in renal cell carcinoma (RCC) patients.
- To evaluate temsirolimus as a treatment option for advanced RCC.
Main Methods:
- A review of clinical findings and safety data for temsirolimus in RCC patients.
- Analysis of a Phase III clinical trial comparing temsirolimus to interferon-alfa (IFN-α).
Main Results:
- Temsirolimus demonstrated statistically significant advantages over IFN-α in overall survival (OS) and progression-free survival (PFS) for poor-prognosis RCC patients.
- Median OS improved by 49% and median PFS approximately doubled with temsirolimus compared to IFN-α.
- Subset analysis suggests potential utility in metastatic non-clear cell carcinoma.
Conclusions:
- Temsirolimus is established as a standard treatment for RCC patients with poor prognostic features.
- Further studies are needed for untreated favorable and intermediate-risk clear cell, and refractory metastatic RCC patients.
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