Reza Mehrazin, MD, discusses the findings of the phase III CARMENA trial in metastatic renal-cell carcinoma.
Reza Mehrazin, MD, assistant professor of urology, Mount Sinai Hospital, discusses the findings of the phase III CARMENA trial in metastatic renal-cell carcinoma (RCC).
In the trial, patients with metastatic RCC were randomized to receive either cytoreductive nephrectomy plus sunitinib (Sutent) or sunitinib alone. At a median follow-up of 50.9 months, results showed that patients who were given sunitinib alone experienced a longer median overall survival versus those who underwent surgery plus sunitinib, at 18.4 months versus 13.9 months, respectively (HR, 0.89; 95% CI, 0.71-1.10). Updated results from the final analysis of the trial showed a median OS of 15.6 months with surgery plus sunitinib versus 19.8 months with sunitinib alone. Investigators concluded that those who received medical therapy only had better OS outcomes, says Mehrazin.
This trial has issues that have been heavily discussed in the field, adds Mehrazin. For example, approximately 44% of patients in the surgical arm were poor risk; normally, these patients would not be considered operable. Additionally, many of the patients in both arms were crossed over; some of those in the surgical arm never had surgery and some in the sunitinib arm had surgery.
Also, the volume of the cases per each center is questionable, according to Mehrazin, because, on average, it comes down to less than 1 patient per center per year. This is notable, because volume is important, adds Mehrazin. These are the kind of surgeries that must be conducted at high-volume centers because the outcomes are directly correlated, concludes Mehrazin.