阿帕替尼与索拉非尼治疗晚期肝细胞癌患者的初步研究。
Apatinib versus sorafenib in patients with advanced hepatocellular carcinoma: a preliminary study.
作者信息
He Wei, Liao Leen, Hu Dandan, Li Binkui, Wang Chenwei, Qiu Jiliang, Liao Yadi, Liu Wenwu, Yang Zhiwen, Zhang Yuanping, Yuan Yichuan, Li Kai, Yuan Yunfei, Zheng Yun
机构信息
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, China.
Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, Sun Yat-sen University Cancer Center, Guangzhou, China.
出版信息
Ann Transl Med. 2020 Aug;8(16):1000. doi: 10.21037/atm-20-5298.
BACKGROUND
Apatinib, a selective inhibitor of vascular endothelial growth factor receptor 2 (VEGFR 2), has exhibited modest antitumor efficacy in hepatocellular carcinoma (HCC). We aimed to evaluate the effectiveness and tolerability of apatinib versus sorafenib in patients with advanced HCC.
METHODS
All patients with advanced HCC who underwent sorafenib or apatinib between January 2016 to December 2017 were retrospectively reviewed. Seventy-two patients received apatinib (26 patients, 500 mg, daily) or sorafenib (46 patients, 400 mg, twice daily) until disease progression or intolerable toxicities. Primary outcome was progression-free survival (PFS). Secondary outcomes included overall survival (OS), objective response rate (ORR) per modified response evaluation criteria in solid tumors (RECIST), disease control rate (DCR), and safety.
RESULTS
The median follow-up was 13.2 (5.7-20.7) months. The 1-year OS for apatinib of 62.0% was comparable to that of sorafenib [64.2%, hazard ratio (HR), 1.15; 95% confidence interval (CI), 0.369-3.58]. The median PFS was 4.1 months in the apatinib group (95% CI, 3.2 to 7.4 months) and 3.6 months in the sorafenib group (95% CI, 2.7 to 5.9 months; HR, 1.03; 95% CI, 0.586 to 1.800; P=0.925). The apatinib group exhibited higher ORR (19.2% 2.2%, P=0.012) but similar DCR (57.7% 50%, P=0.530) compared with the sorafenib group. The most common any-grade adverse events in the apatinib and sorafenib groups were hand and foot syndrome (53.8% 50%), hypertension (50% 19.6%), diarrhea (34.6% 28.3%), and elevated transaminase (57.7% 63%).
CONCLUSIONS
Compared with sorafenib, apatinib yielded comparable PFS and OS, and even better ORR, in patients with advanced HCC.
背景
阿帕替尼是一种血管内皮生长因子受体2（VEGFR 2）的选择性抑制剂，在肝细胞癌（HCC）中已显示出一定的抗肿瘤疗效。我们旨在评估阿帕替尼与索拉非尼在晚期HCC患者中的有效性和耐受性。
方法
回顾性分析2016年1月至2017年12月期间接受索拉非尼或阿帕替尼治疗的所有晚期HCC患者。72例患者接受阿帕替尼（26例患者，每日500 mg）或索拉非尼（46例患者，每日两次，每次400 mg）治疗，直至疾病进展或出现无法耐受的毒性。主要结局是无进展生存期（PFS）。次要结局包括总生存期（OS）、根据实体瘤改良反应评估标准（RECIST）的客观缓解率（ORR）、疾病控制率（DCR）和安全性。
结果
中位随访时间为13.2（5.7 - 20.7）个月。阿帕替尼组的1年总生存率为62.0%，与索拉非尼组相当[64.2%，风险比（HR），1.15；95%置信区间（CI），0.369 - 3.58]。阿帕替尼组的中位PFS为4.1个月（95% CI，3.2至7.4个月），索拉非尼组为3.6个月（95% CI，2.7至5.9个月；HR，1.03；95% CI，0.586至1.800；P = 0.925）。与索拉非尼组相比，阿帕替尼组显示出更高的ORR（19.2% 对2.2%，P = 0.012），但DCR相似（57.7% 对50%，P = 0.530）。阿帕替尼组和索拉非尼组最常见的任何级别不良事件为手足综合征（53.8% 对50%）、高血压（50% 对19.6%）、腹泻（34.6% 对28.3%）和转氨酶升高（57.7% 对63%）。
结论
与索拉非尼相比，阿帕替尼在晚期HCC患者中产生了相当的PFS和OS，甚至更好的ORR。
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