Doctors conclude temsirolimus is effective new treatment for advanced renal cell carcinoma

n patients randomized to receive temsirolimus (49 percent) compared with patients treated with interferon only. Patients treated with temsirolimus and interferon combined had a 15 percent increase in median survival compared with interferon alone. The median survival for temsirolimus alone was 10.9 months compared with and 8.4 months for the temsirolimus and interferon, and 7.3 months for the interferon.

"This is a modest improvement in survival but the patients in the study had the most advanced tumors," says Hudes. "It would be reasonable to hypothesize that temsirolimus could provide greater benefit to patients with less extensive metastatic disease. Only a randomized, clinical trial will give us that definitive knowledge."

Temsirolimus was better tolerated than interferon. Fewer patients treated with temsirolimus had grade 3 or 4 (severe) side effects compared with those treated with interferon or the combination of interferon and temsirolimus. Asthenia, anemia, nausea, dyspnea, and rash were the most common side effects associated with temsirolimus.

Temsirolimus (formerly known as CCI-779) blocks the function of the mammalian target of rapamycin (mTOR), a key protein within cells that regulates cell proliferation, growth and survival. Temsirolimus may also block angiogenesis, a process that tumors use to create a blood supply to maintain their growth.

In November 2006, Wyeth filed an application with the U.S. Food and Drug Administration for approval to market temsirolimus (brand name Torisel) for the treatment of advanced renal cell carcinoma. A decision on approval is expected before July 2007.


Contact: Karen Mallet
Fox Chase Cancer Center

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