Presentation Authors: Sohrab Arora*, Akshay Sood, Deepansh Dalela, Amit Patel, Jacob Keeley, Audrey Fotouhi, Nikola Rakic, Ulyana Prokopiv, Detroit, MI, Quoc-Dien Trinh, Boston, MA, Craig G Rogers, Mani Menon, Firas Abdollah, Detroit, MI
Introduction: The CARMENA phase III randomized trial reported that overall survival with sunitinib alone is noninferior to the combination of nephrectomy followed by sunitinib in patients with intermediate-to-poor risk metastatic renal-cell carcinoma (RCC). Our aim was to test the external validity of the trial in US patients.
Methods: We identified 2800 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 (Figure 1). Demographic characteristics, namely, age, tumor size, number of metastatic sites, gender, Fuhrman&[prime]s grade, pathological T stage, and the sites of metastases were then compared with the CARMENA cohort.
Results: We found that CARMENA 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) (see table 1).
Conclusions: Our 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. Our 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.