Department of Oncology, General Hospital of The Yangtze River Shipping, Wuhan, Hubei, China.
Department of Anatomy, College of Basic Medicine, Guilin Medical University, Guilin, China.
Medicine (Baltimore). 2023 Sep 8;102(36):e34983. doi: 10.1097/MD.0000000000034983.
To assess the safety and efficacy of sorafenib and sunitinib as first-line treatments for metastatic renal cell carcinoma (mRCC), to provide evidence-based support for clinical decision-making regarding rational drug use.
Until May 10, 2023, a comprehensive search was conducted across PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, China National Knowledge Infrastructure, and Wanfang databases to identify clinical studies comparing sorafenib with sunitinib as first-line treatment for mRCC. The literature was screened, data extracted, and quality evaluated independently by 2 researchers. Meta-analysis was conducted using Revman5.4 software.
A total of 3741 patients were enrolled in 20 studies. The meta-analysis results indicated that there were no significant differences in the 2- and 5-year progression-free survival (PFS) and overall survival (OS) rates between the sorafenib and sunitinib groups (P > .05). The disease control rate (DCR) was comparable between the 2 groups (P > .05), while the objective response rate (ORR) was higher in the sunitinib group (P = .03). However, subgroup analysis revealed no significant differences in ORR, DCR, 2- and 5-year PFS, and OS rates between sorafenib and sunitinib among both Asian populations as well as European and American populations (P > .05). In terms of drug-related adverse events, the incidence of grade ≥ 3 hypertension, leukopenia, neutropenia, thrombocytopenia, anemia, nausea and vomiting were significantly lower in the sorafenib group compared to the sunitinib group (P < .05).
In the first-line treatment of mRCC, sorafenib exhibits comparable efficacy to sunitinib but with lower toxicity.
评估索拉非尼和舒尼替尼作为转移性肾细胞癌(mRCC)一线治疗的安全性和疗效,为临床合理用药决策提供循证支持。
截至 2023 年 5 月 10 日,通过对 PubMed、EMBASE、Cochrane 图书馆、ClinicalTrials.gov、中国国家知识基础设施和万方数据库进行全面检索,以确定比较索拉非尼与舒尼替尼作为 mRCC 一线治疗的临床研究。由 2 名研究人员独立筛选文献、提取数据和评估质量。使用 Revman5.4 软件进行荟萃分析。
共有 20 项研究纳入 3741 例患者。荟萃分析结果表明,索拉非尼组与舒尼替尼组的 2 年和 5 年无进展生存率(PFS)和总生存率(OS)率无显著差异(P>0.05)。两组疾病控制率(DCR)相当(P>0.05),但舒尼替尼组客观缓解率(ORR)较高(P=0.03)。然而,亚组分析显示,在亚洲人群以及欧美人群中,索拉非尼与舒尼替尼在 ORR、DCR、2 年和 5 年 PFS 以及 OS 率方面均无显著差异(P>0.05)。在药物相关不良反应方面,索拉非尼组高血压、白细胞减少症、中性粒细胞减少症、血小板减少症、贫血、恶心和呕吐等≥3 级不良反应的发生率明显低于舒尼替尼组(P<0.05)。
在 mRCC 的一线治疗中,索拉非尼的疗效与舒尼替尼相当,但毒性更低。