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.
Keywords: Advanced hepatocellular carcinoma; apatinib; second-line therapy; transcatheter arterial chemoembolization.