RAD001 versus placebo in patients with metastatic renal cell carcinoma (RCC) after progression on VEGFr-TKI therapy: Results from a randomized, double-blind, multicenter phase III study

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 4, 2008

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RAD001 versus placebo in patients with metastatic renal cell carcinoma (RCC) after progression on VEGFr-TKI therapy: Results from a randomized, double-blind, multicenter phase III study

RAD001 (Everolimus) is an oral targeted therapy medication that inhibits mTOR, which regulates cell proliferation (growth) and angiogenesis (development of blood vessels). This phase III study compares RAD001 to placebo in patients with metastatic renal cell cancer that has progressed with either sorafenib or sutent.

Many studies perform “interim analyses”, where they stop the study partway through, evaluate the results, and stop the study if one arm appears to be superior. This study was stopped after a second analysis found the RAD001 arm to be superior. This allows those patients receiving placebo to receive the therapy as well.

The median progression-free survival was 4.0 months in the RAD001 arm versus 1.9 months in the placebo arm. Benefit was seen in patients classified as favorable risk, intermediate risk, and poor risk. 60% of those receiving RAD001 achieved stable disease, versus 30% on placebo.

Toxicities reported include stomatitis, anemia, and aesthesia. Rarely, pneumonitis, hypercholesterolemia and hyperglycemia were seen in the RAD001 arm.

The benefit of everolimus over placebo is clear from this study, and the authors’ conclusion that everolimus should be a standard of care in this setting seems valid, particularly given the fact that no other agent has been demonstrated to be as efficacious to date. Having said this, with the recent advent of targeted agents available to treat metastatic RCC, the timing and sequence with which they will be ultimately used to achieve the best outcomes is undetermined as of yet. Further studies may look at combining therapies or comparing sorafenib/sutent to everolimus to better clarify how to best utilize these therapies.


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