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

机译:索拉非尼与舒尼替尼作为转移性肾细胞癌患者一线治疗的疗效和安全性:最大的单中心回顾性分析

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摘要

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.
机译:我们进行了这项最大的单中心回顾性研究,以确定索拉非尼和舒尼替尼作为中国患者转移性肾细胞癌(mRCC)一线治疗的疗效,以验证直接比较一线疗效的潜在数据索拉非尼和舒尼替尼治疗mRCC。从2006年11月至2015年3月,我们审查了北京大学肿瘤医院的病历,发现169例接受索拉非尼(400 mg口服BID,连续4周周期)和165例接受舒尼替尼(6周内每天口服50 mg)周期; 4/2时间表)作为一线靶向治疗。中位随访时间为23.0个月。在索拉非尼和舒尼替尼组中,无进展生存期(PFS)没有显着差异(分别为9.0个月[95%CI:8.00-12.00]与11.0个月[95%CI:9.00-14.00]; P = 0.6289)和总生存期(OS)(分别为28.0个月[95%CI:24.00-34.00]与28.0个月[95%CI:19.00-33.00]; P = 0.979)。还根据Karnofsky表现状态(KPS),病理类型,纪念斯隆·凯特琳癌症中心评分和转移进行了亚组分析。多变量分析显示,索拉非尼治疗的患者在KPS <90且PFS显着更好的患者中具有更好的疗效(危险比:0.460 [95%CI:0.222-0.954])。最常见的不良事件是手足皮肤反应和血小板减少,这是可以控制的。总体而言,索拉非尼和舒尼替尼在晚期肾癌的治疗中未见明显差异。但是,与索拉非尼相关的毒性较小,且在亚组(非透明细胞癌且KPS <90)中具有更高的疗效,表明索拉非尼是mRCC患者的有效一线治疗药物。

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