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阿帕替尼与经导管肝动脉化疗栓塞用于晚期肝细胞癌二线治疗的疗效和安全性:一项回顾性队列研究。

Efficacy and safety of apatinib and transcatheter arterial chemoembolization as second-line therapy for advanced hepatocellular carcinoma: A retrospective cohort study.

机构信息

Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection and Immunology, School of Basic Medical Science, Shandong University; Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jing 5 Rd, Ji'nan, Shandong Province, China.

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jing 5 Rd, Ji'nan, Shandong Province, China.

出版信息

J Cancer Res Ther. 2023 Feb;19(1):57-63. doi: 10.4103/jcrt.jcrt_2427_22.

Abstract

BACKGROUND

Transarterial chemoembolization (TACE) and tyrosine kinase inhibitors (TKIs) have demonstrated clinical efficacy against hepatocellular carcinoma (HCC) as first-line therapy. However, there is limited evidence on the efficacy and safety of apatinib plus TACE as second-line treatment for advanced HCC.

AIM

To evaluate the efficacy and safety of apatinib in combination with TACE for advanced HCC patients with disease progression or intolerant to first-line treatment.

PATIENTS AND METHODS

Between May 2019 and January 2022, 72 advanced HCC patients received apatinib plus TACE as second-line treatment. Clinical parameters, efficacy, and safety were assessed. The primary endpoint was progression-free survival (PFS) and the secondary the objective response rate (ORR) and disease control rate (DCR).

RESULTS

The median follow-up duration was 14.7 months (range, 4.5-26.0). The median PFS from the beginning of treatment was 7.1 months (1.0-15.2) and its 95% CI was 6.6-8.2 according to Kaplan-Meier analysis. The ORR and DCR were 34.7% (95% CI: 23.9%-46.9%) and 48.6% (95% CI: 36.7%-60.7%), respectively. By the cutoff date, 33 patients (45.8%) had died and 39 (54.2%) were undergoing survival follow-up. The estimated median overall survival (mOS) was 22.3 months (95% CI: 20.6-24.0) by Kaplan-Meier analysis. The most common apatinib-related adverse events of any grade were hypertension [35 (48.6%)], appetite loss [30 (41.6%)], and hand-foot syndrome [21 (29.2%)].

CONCLUSION

The combination of apatinib and TACE as second-line therapy demonstrated promising clinical efficacy and tolerable adverse effects for advanced HCC patients.

摘要

背景

经动脉化疗栓塞术(TACE)和酪氨酸激酶抑制剂(TKIs)已被证实对肝细胞癌(HCC)具有临床疗效,可作为一线治疗。然而,关于阿帕替尼联合 TACE 作为二线治疗晚期 HCC 的疗效和安全性的证据有限。

目的

评估阿帕替尼联合 TACE 治疗一线治疗进展或不耐受的晚期 HCC 患者的疗效和安全性。

患者与方法

2019 年 5 月至 2022 年 1 月,72 例晚期 HCC 患者接受阿帕替尼联合 TACE 作为二线治疗。评估临床参数、疗效和安全性。主要终点为无进展生存期(PFS),次要终点为客观缓解率(ORR)和疾病控制率(DCR)。

结果

中位随访时间为 14.7 个月(范围:4.5-26.0)。从治疗开始时的中位 PFS 为 7.1 个月(1.0-15.2),根据 Kaplan-Meier 分析,其 95%CI 为 6.6-8.2。ORR 和 DCR 分别为 34.7%(95%CI:23.9%-46.9%)和 48.6%(95%CI:36.7%-60.7%)。截至截止日期,33 例患者(45.8%)死亡,39 例(54.2%)正在进行生存随访。Kaplan-Meier 分析估计的中位总生存期(mOS)为 22.3 个月(95%CI:20.6-24.0)。任何级别的阿帕替尼相关不良事件最常见的是高血压[35 例(48.6%)]、食欲下降[30 例(41.6%)]和手足综合征[21 例(29.2%)]。

结论

阿帕替尼联合 TACE 作为二线治疗晚期 HCC 患者具有良好的临床疗效和可耐受的不良反应。

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