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.
J Cancer Res Ther. 2023 Feb;19(1):57-63. doi: 10.4103/jcrt.jcrt_2427_22.
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.
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.
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).
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%)].
The combination of apatinib and TACE as second-line therapy demonstrated promising clinical efficacy and tolerable adverse effects for advanced HCC patients.
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。
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。
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)。
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%)]。
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。