Dr. Arora and colleagues identified 2800 patients with metastatic clear cell RCC who underwent cytoreductive nephrectomy, between 2010 and 2015, within the National Cancer Database (NCDB), and met the inclusion criteria of CARMENA trial. Demographic characteristics, namely, age, tumor size, number of metastatic sites, gender, Fuhrman’s grade, pathological T stage, and the sites of metastases were then compared with the CARMENA cohort.
Dr. Arora then summarized the baseline demographics from the CARMENA trial which recruited older patients (median age 62.5 vs. 60 years), with a higher number of metastatic sites (median 2 vs. 1) involved. The burden of metastasis in lymph nodes (35% vs. 26% in the NCDB), lung (79% vs. 62% in NCDB), and bone (36% vs. 30% in NCDB) was higher in the trial compared to NCDB (all p < 0.001). Interestingly, this was despite the higher tumor grade (Fuhrman grade 3/4: 2143/2800 [77%] vs. 147/306 [48%]), and higher T stage (T3/T4: 2022/2800 [72%] vs. 72/116 [62%]) in the NCDB cohort (both p < 0.001).
Dr. Arora concluded that this study indicates that the CARMENA trial recruited patients with higher metastatic burden than those seen in US practice, which may have affected the trial outcomes. Their findings emphasize the role of appropriate patient selection during clinical practice, as well as during interpretation of the results of the trials on this subject.
During the discussion after this presentation, it was stressed that CARMENA was a non-inferiority trial and proper selection of patients for cytoreductive nephrectomy could still be beneficial in good to intermediate risk patients.
Presented by: Sohrab Arora, MD, MS, MCh, Vattikuti Urology Institute, Henry Ford Health System