We conducted this largest, single-center, retrospective study to determine the efficacy of
sorafenib versus
sunitinib as first-line
therapy for metastatic
renal cell carcinoma (mRCC) in Chinese patients to validate the potential data on direct comparison of the efficacy of first-line treatment with
sorafenib and
sunitinib in the treatment of mRCC. From November 2006 to March 2015, we reviewed medical records from Peking University Cancer Hospital and found 169 patients receiving
sorafenib (400 mg orally BID continuously in a 4-week cycle) and 165 patients receiving
sunitinib (50 mg orally daily in a 6-week cycle; 4/2 schedule) as the first-line targeted
therapy. Median follow-up was 23.0 months. In
sorafenib and
sunitinib groups, there is no significant difference in progression-free survival (PFS) (9.0 months [95%CI:8.00-12.00] vs 11.0 months [95%CI:9.00-14.00], respectively; P=0.6289) and overall survival (OS) (28.0 months [95%CI:24.00-34.00] vs 28.0 months [95% CI:19.00-33.00], respectively; P=0.979). Subgroup analysis based on Karnofsky performance status (KPS), pathological type, Memorial Sloan Kettering
Cancer Center score, and
metastasis was also conducted. Multivariate analysis revealed that
sorafenib treated patients had superior efficacy in patients with a KPS of <90 and significantly better PFS (hazard ratio: 0.460 [95% CI:0.222-0.954]). Most common adverse events were hand-foot skin reaction and
thrombocytopenia which were manageable. Overall, no significant differences were seen between
sorafenib and
sunitinib in the treatment of advanced
renal cancer. However, fewer toxicities associated with
sorafenib and superior efficacy in subgroups (non-clear cell
carcinoma and KPS <90) indicates
sorafenib as an effective first-line treatment agent in patients with mRCC.