Efficacy and safety of sorafenib versus sunitinib as first-line treatment in patients with metastatic renal cell carcinoma: largest single-center retrospective analysis.

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.