Everolimus improved survival in metastatic RCC

CHICAGO -- Everolimus prolonged progression–free survival in patients with metastatic renal cell carcinoma who progressed after treatment with other targeted therapies, according to data presented at the 2008 ASCO Annual Meeting.

“Everolimus is the first and only agent with established clinical benefit in patients with renal cell carcinoma after VEGF-r tyrosine kinase inhibitor treatment,” said Robert J. Motzer, MD.“Everolimus should be the standard of care in this setting, pending regulatory approval.”

Motzer, an attending physician at Memorial Sloan-Kettering Cancer Center, and colleagues conducted a randomized, multicenter, phase-3 trial to evaluate everolimus in patients with metastatic renal cell carcinoma with clear-cell component. The researchers randomly assigned 410 patients 2:1 to 10 mg per day everolimus (RAD001, Cetican) plus best supportive care (n=272) or best supportive care alone (n=138).

All patients included in the study had progressed after six months of treatment with sunitinib and/or sorafenib (Nexavar, Bayer). The primary endpoint was progression-free survival.

At six months, 26% of patients in the everolimus group had not progressed compared with only 2% in the placebo group. The median progression-free survival was 4 months in the everolimus group compared with 1.9 months in the placebo group.

Although there were more toxicities with everolimus compared with placebo, overall the treatment was well-tolerated, according to the researchers. The most common adverse events were mouth ulcers, anemia and weakness.

Motzer RJ. #LB5026. Presented at: 2008 ASCO Annual Meeting; May 30-June 2, 2008; Chicago.

I consider this a very very important trial. We now have a second line treatment for those patients with renal cell carcinoma.

-- Nicholas J. Petrelli, MD

Professor of Surgery, Thomas Jefferson University