Sunitinib versus sorafenib as first-line therapy for patients with metastatic renal cell carcinoma with favorable or intermediate MSKCC risk factors: A multicenter randomized trial, CROSS-J-RCC.

502 Background: Sorafenib (SO), an earlier introduced kinase inhibitor, and sunitinib (SU), a standard first-line treatment drug for metastatic renal cell carcinoma (mRCC), were associated with progression-free survival (PFS) of 5.7 and 11 months (M) in independent clinical trials, respectively. We compared PFS of first-line SU and SO in a multicenter, randomized, open-label, phase III trial. Methods: Patients with untreated, measurable (by RECIST v1.1) clear-cell mRCC stratified according to MSKCC risk criteria, nephrectomy, and institution were randomized in 1:1 to receive SU (50 mg qd 4 wks on-2 wks off) or SO (400 mg bid). The calculated sample size was 59/group for α = 0.05, β = 0.10, and a censoring rate of 15%. Results: Of 124 enrolled patients, from Feb. 2010 to Jul. 2012, from 39 institutions, 120 were evaluable (SU, 57 and SO, 63). Patient baseline characteristics in the SU vs SO groups were as follows: favorable risk, 21% vs 22%; presence of stable brain metastasis, 8.8% vs 1.6% and with nephre...