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索拉非尼作为转移性肾细胞癌一线治疗药物,其毒性低于舒尼替尼,疗效相当:系统评价和荟萃分析。

Sorafenib exhibits lower toxicity and comparable efficacy to sunitinib as a first-line treatment for metastatic renal cell carcinoma: A systematic review and meta-analysis.

机构信息

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.

出版信息

Medicine (Baltimore). 2023 Sep 8;102(36):e34983. doi: 10.1097/MD.0000000000034983.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSION

In the first-line treatment of mRCC, sorafenib exhibits comparable efficacy to sunitinib but with lower toxicity.

摘要

背景

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。

方法

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。

结果

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)。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c812/10489528/9199b7b3490f/medi-102-e34983-g001.jpg

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