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索拉非尼与阿帕替尼治疗中晚期肝细胞癌的疗效和安全性:一项对比性回顾性研究

Efficacy and safety of sorafenib versus apatinib in the treatment of intermediate and advanced hepatocellular carcinoma: a comparative retrospective study.

作者信息

Wang Yizhuo, Gou Qing, Xu Rongde, Chen Xiaoming, Zhou Zejian

机构信息

Department of Interventional Oncology, Guangdong Academy of Medical Sciences, Guangdong General Hospital, Guangzhou, Guangdong, People's Republic of China.

Medical College Shantou University, Shantou, Guangdong, People's Republic of China.

出版信息

Onco Targets Ther. 2018 Jun 12;11:3407-3413. doi: 10.2147/OTT.S161023. eCollection 2018.

Abstract

OBJECTIVE

To compare the efficacy and safety profiles of sorafenib and apatinib in patients with intermediate- and advanced-stage hepatocellular carcinoma (HCC).

METHODS

This was a single-center, retrospective study where we collected the clinical data of 72 patients, diagnosed with intermediate or advanced HCC from January 2014 to December 2016. Depending on the treatment received, 38 patients were categorized into group S (sorafenib group) and 34 into group A (apatinib group). The patients in group A received the initial recommended dose of 750 mg once daily (QD), which was reduced to 250 mg QD in the case of any class 3 or 4 adverse event (AE). Sorafenib was administered orally 400 mg twice daily (BID), and dose was modified to 400 mg or 200 mg QD in the case of grade 3 or 4 AEs. The median overall survival (OS), progression-free survival (PFS), and AEs reported in the two groups were analyzed and compared.

RESULTS

Among the 38 patients treated with sorafenib, one patient had complete response (CR), 5 patients had partial response (PR), and 10 patients had stable disease (SD), and among the 34 patients treated with apatinib, 6 patients had PR and 7 patients had SD with no cases of CR. PFS in group S was significantly longer compared with that in group A (7.39 vs 4.79 months, respectively, =0.031). Similar observations were made for median OS (10.4 months in group S vs 7.18 months in group A, =0.011). However, there was no significant difference in the objective response rates (ORRs) among the study population (15.7 vs 17.6%, =0.829). Common AEs in group S included hand and foot syndrome (HFS) and diarrhea, whereas common AEs in group A included hypertension, proteinuria, and increased transaminase.

CONCLUSION

Our study showed promising clinical outcome with apatinib, but the sorafenib group exhibited better clinical efficacy with no significant difference in safety profile.

摘要

目的

比较索拉非尼和阿帕替尼治疗中晚期肝细胞癌(HCC)患者的疗效和安全性。

方法

这是一项单中心回顾性研究,收集了2014年1月至2016年12月期间诊断为中晚期HCC的72例患者的临床资料。根据接受的治疗,38例患者被分为S组(索拉非尼组),34例患者被分为A组(阿帕替尼组)。A组患者初始推荐剂量为每日一次750mg(QD),若出现任何3级或4级不良事件(AE),剂量减至250mg QD。索拉非尼口服给药,每日两次,每次400mg(BID),若出现3级或4级AE,剂量调整为400mg或200mg QD。分析并比较两组报告的中位总生存期(OS)、无进展生存期(PFS)和AE。

结果

在接受索拉非尼治疗的38例患者中,1例患者完全缓解(CR),5例患者部分缓解(PR),10例患者病情稳定(SD);在接受阿帕替尼治疗的34例患者中,6例患者PR,7例患者SD,无CR病例。S组的PFS明显长于A组(分别为7.39个月和4.79个月,=0.031)。中位OS也有类似观察结果(S组为10.4个月,A组为7.18个月,=0.011)。然而,研究人群的客观缓解率(ORR)无显著差异(15.7%对17.6%,=0.829)。S组常见AE包括手足综合征(HFS)和腹泻,而A组常见AE包括高血压、蛋白尿和转氨酶升高。

结论

我们的研究显示阿帕替尼有良好的临床结果,但索拉非尼组临床疗效更佳,安全性无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df39/6003281/bcb238b19c38/ott-11-3407Fig1.jpg

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