比较索拉非尼治疗后进展的晚期肝细胞癌患者二线治疗中使用雷莫芦单抗、regorafenib 和卡博替尼的疗效和安全性：一项网络荟萃分析。
Comparative efficacy and safety for second-line treatment with ramucirumab, regorafenib, and cabozantinib in patients with advanced hepatocellular carcinoma progressed on sorafenib treatment: A network meta-analysis.
机构信息
Department of Medical Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, China.
Department of Radiation Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, China.
出版信息
Medicine (Baltimore). 2021 Sep 24;100(38):e27013. doi: 10.1097/MD.0000000000027013.
BACKGROUND
The present network meta-analysis was conducted to perform an indirect comparison among ramucirumab, regorafenib, and cabozantinib in patients with advanced hepatocellular carcinoma (HCC) progressed on sorafenib treatment.
METHODS
A systematic review through Medline, Embase, and Cochrane library was developed, with eligible randomized clinical trials been included. Hazard ratios (HRs) including progression-free survival (PFS), overall survival (OS), odds ratios of disease control rate (DCR), objective response rate (ORR), and adverse events were compared indirectly with network meta-analysis using random model in software STATA version 13.0.
RESULTS
A total of 4 randomized clinical trials including 2137 patients met the eligibility criteria and enrolled. Indirect comparisons showed that there was no statistical difference observed in the indirect comparison of PFS, OS, ORR, or DCR among agents of regorafenib, cabozantinib, and ramucirumab in advanced HCC patients with elevated α-fetoprotein (AFP) (400 ng/mL or higher). However, in patients with low-level AFP (lower than 400 ng/mL), regorafenib was the only agent associated with significant superiority in OS, compared with placebo (hazard ratio 0.67, 95% CI, 0.50-0.90).
CONCLUSIONS
The present network meta-analysis revealed that there might be no statistical difference observed in the indirect comparison of PFS, OS, ORR, or DCR among regorafenib, cabozantinib, or ramucirumab in advanced HCC patients with elevated AFP (400 ng/mL or higher). However, in patients with low-level AFP (lower than 400 ng/mL), regorafenib might be associated with significant superiority in OS, compared to placebo, which need further investigation in clinical practice.
背景
本网络荟萃分析旨在对索拉非尼治疗后进展的晚期肝细胞癌（HCC）患者中，雷戈非尼、regorafenib、卡博替尼 cabozantinib 进行间接比较。
方法
通过 Medline、Embase 和 Cochrane 图书馆进行系统综述，纳入合格的随机临床试验。使用 STATA 版本 13.0 软件中的随机模型，通过网络荟萃分析间接比较无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）、客观缓解率（ORR）和不良事件的风险比（HRs）。
结果
共有 4 项随机临床试验，包括 2137 名患者符合纳入标准。间接比较显示，在 AFP（400ng/ml 或更高）升高的晚期 HCC 患者中，雷戈非尼、卡博替尼和 ramucirumab 三种药物之间的 PFS、OS、ORR 或 DCR 的间接比较没有统计学差异。然而，在 AFP 水平较低（低于 400ng/ml）的患者中，与安慰剂相比，regorafenib 是唯一与 OS 显著相关的药物（风险比 0.67，95%可信区间 0.50-0.90）。
结论
本网络荟萃分析显示，在 AFP（400ng/ml 或更高）升高的晚期 HCC 患者中，雷戈非尼、卡博替尼或 ramucirumab 三种药物之间的 PFS、OS、ORR 或 DCR 的间接比较可能没有统计学差异。然而，在 AFP 水平较低（低于 400ng/ml）的患者中，与安慰剂相比，regorafenib 可能在 OS 方面具有显著优势，这需要在临床实践中进一步研究。
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