WEDNESDAY, July 23 (HealthDay News) -- Everolimus improves progression-free survival compared to placebo in patients with progressive, metastatic renal cell carcinoma that failed other targeted therapies, according to research published online July 23 in The Lancet.
Robert J. Motzer, M.D., of the Memorial Sloan-Kettering Cancer Center in New York City, and colleagues randomized patients with metastatic renal cell carcinoma that had progressed while receiving sunitinib, sorafenib or both to receive 10 mg of everolimus once daily or placebo, along with best supportive care.
The researchers stopped the trial after 191 progression events occurred, finding a significant difference in efficacy favoring the everolimus treatment and believing it unethical to continue without providing all patients everolimus. The investigators report progression events in 101 of 272 (37 percent) in the everolimus group and 90 of 138 (65 percent) in the placebo group. While most adverse effects were mild, treatment with everolimus was associated with increased side effects compared to placebo and included stomatitis, rash and fatigue.
"On the basis of the results of this trial, we believe that everolimus should now be considered as the standard-of-care in patients with metastatic renal cell carcinoma whose disease has progressed after treatment with VEGF-targeted therapies," the authors conclude. In an accompanying editorial, Jennifer J. Knox, M.D., of the University of Toronto in Ontario, Canada, states, "I would encourage international regulatory boards to accept these data as evidence of clinical benefit of everolimus in metastatic renal cell carcinoma that has progressed on prior targeted therapies."
Several of the study authors report financial relationships with the pharmaceutical industry.
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