Key clinical point: Sunitinib alone was not inferior to nephrectomy plus sunitinib in patients with MSKCC intermediate- or poor-risk metastatic, clear cell renal cell carcinoma (RCC) who were suitable candidates for nephrectomy.
Major finding: Overall survival was not inferior in the sunitinib arm of the trial.
Study details: A randomized phase 3 trial involving 450 patients with metastatic clear-cell RCC who were suitable candidates for nephrectomy.
Disclosures: The authors reported disclosures related to Bristol-Myers Squibb, EUSA Pharma, Ipsen, Novartis, Pfizer, and Roche, among others.
Méjean A et al. N Engl J Med. 2018 Aug 2. doi: 10.1056/NEJMoa1803675.
The finding of the CARMENA trial that sunitinib was not inferior to nephrectomy should not lead to the abandonment of nephrectomy, according to Robert J. Motzer, MD, and Paul Russo, MD.
Instead, the results emphasize the importance of carefully selecting patients for nephrectomy based on published risk models, Dr. Motzer and Dr. Russo wrote in an editorial.
“We think that nephrectomy in properly chosen patients with metastatic renal cell carcinoma remains an essential component of care,” they said.
It is not surprising that the CARMENA study met its noninferiority endpoint, as it was “heavily weighted” toward poor-risk patients, they added.
Over an 8-year period, 79 European centers enrolled 450 patients out of 576 patients planned, or just 0.7 patients per site per year.
“This slow and incomplete enrollment raises the possibility that many centers saw few patients with stage IV disease, or that when surgeons saw patients with intermediate-risk disease who were likely to benefit from combination therapy, they were unwilling for them to undergo randomization and instead treated them outside the trial,” they wrote.
Over the same time frame at Dr. Motzer’s and Dr. Russo’s center, there were 189 patients with stage IV disease, or about 24 patients each year.
“We took care to avoid operating on poor-risk patients with extensive metastatic disease, instead focusing on intermediate-risk patients,” they explained in their editorial.
Dr. Motzer and Dr. Russo are with Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College in New York. These comments come from their editorial in the New England Journal of Medicine. Dr. Russo had nothing to disclose. Dr. Motzer reported disclosures related to Genentech/Roche, Pfizer, Novartis, Exelixis, Eisai, Bristol-Myers Squibb, and Merck outside the submitted work.
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