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三氧化二砷/碘油乳剂经动脉化疗栓塞联合阿帕替尼治疗晚期肝细胞癌的疗效和安全性

Efficacy and Safety of the Arsenic Trioxide/Lipiodol Emulsion in the Transcatheter Arterial Chemoembolization Combined with Apatinib in the Treatment of Advanced Hepatocellular Carcinoma.

作者信息

Li Zhaonan, Chen Quanjing, Zhang Wenguang, Si Guangyan, Li Jing, Jiao Dechao, Han Xinwei

机构信息

Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.

Department of Laboratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.

出版信息

Can J Gastroenterol Hepatol. 2021 Aug 19;2021:5565793. doi: 10.1155/2021/5565793. eCollection 2021.

Abstract

PURPOSE

The goal of this study was to assess the clinical efficacy and safety of the arsenic trioxide (ATO)/lipiodol emulsion in the transcatheter arterial chemoembolization (TACE) combined with apatinib in the treatment of advanced hepatocellular carcinoma (HCC).

METHODS

From December 2015 to February 2017, a total of 87 patients were consecutively enrolled and underwent ATO-TACE (aTACE) combined with apatinib in the treatment of advanced HCC. The treatment response and adverse events were assessed at the first month and third month after aTACE therapy. Progression-free survival (PFS), overall survival (OS), and treatment-related adverse events were also analyzed.

RESULTS

87 patients (57 men; 30 women) were enrolled in the present study. Compared to that at the pre-aTACE examination, the levels of AST and ALT were elevated at the first week after procedure (65.84 U/L ± 22.93 U/L vs. 54.15 U/L ± 19.60 U/L, =0.032; 63.44 U/L ± 22.50 U/L vs. 51.60 U/L ± 13.89 U/L, =0.027, respectively). Most of the adverse events were grade 1 or 2 according to National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE). Of the exception, 4 persons (2%) did have grade 3 hand-foot skin reactions, 1 (1%) had grade 3 diarrhea, 1 (1%) had grade 3 hypertension, and 3 (3%) had grade 3 proteinuria and forced to reduce the dose of apatinib by half. The survival analysis of the combination with aTACE and apatinib therapy found that the median PFS was 10.2 months (95% CI: 8.543-11.857), and the median OS was 23.300 months (95% CI: 20.833-25.767). Additionally, both univariate and multivariate Cox regression revealed that the tumor burden (≤50%) and the patients without portal vein tumor thrombus (PVTT) significantly impacted the patient's PFS and OS and were related to better survival.

CONCLUSION

aTACE combined with apatinib is a safe and promising treatment approach for patients with advanced HCC. Additionally, tumor burden (≤50%) and the patients without PVTT are associated with better PFS and OS.

摘要

目的

本研究旨在评估三氧化二砷(ATO)/碘油乳剂经动脉化疗栓塞术(TACE)联合阿帕替尼治疗晚期肝细胞癌(HCC)的临床疗效和安全性。

方法

2015年12月至2017年2月,共连续纳入87例患者,接受ATO-TACE(aTACE)联合阿帕替尼治疗晚期HCC。在aTACE治疗后的第1个月和第3个月评估治疗反应和不良事件。还分析了无进展生存期(PFS)、总生存期(OS)和治疗相关不良事件。

结果

本研究共纳入87例患者(57例男性;30例女性)。与aTACE术前检查相比,术后第1周AST和ALT水平升高(分别为65.84 U/L±22.93 U/L vs. 54.15 U/L±19.60 U/L,P=0.032;63.44 U/L±22.50 U/L vs. 51.60 U/L±13.89 U/L,P=0.027)。根据美国国立癌症研究所不良事件通用术语标准(CTCAE),大多数不良事件为1级或2级。例外的是,4人(2%)出现3级手足皮肤反应,1人(1%)出现3级腹泻,1人(1%)出现3级高血压,3人(3%)出现3级蛋白尿,被迫将阿帕替尼剂量减半。aTACE与阿帕替尼联合治疗的生存分析发现,中位PFS为10.2个月(95%CI:8.543-11.857),中位OS为23.300个月(95%CI:20.833-25.767)。此外,单因素和多因素Cox回归均显示,肿瘤负荷(≤50%)和无门静脉癌栓(PVTT)的患者对患者的PFS和OS有显著影响,且与更好的生存率相关。

结论

aTACE联合阿帕替尼是治疗晚期HCC患者的一种安全且有前景的治疗方法。此外,肿瘤负荷(≤50%)和无PVTT的患者PFS和OS更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/390b/8397569/c416aa69c15d/CJGH2021-5565793.001.jpg

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