| ObjectiveTo evaluate the safety and effectiveness of drug-eluting bead transarterial chemoembolization(DEB-TACE)combined with lenvatinib in patients with unresectable advanced hepatocellular carcinoma(HCC).Materials and MethodsThis study prospectively collected and retrospectively evaluated medical records from patients with unresectable advanced HCC who underwent DEB-TACE-lenvatinib from November 2018 to December 2019.Lenvatinib(12 mg/day or 8 mg/day for bodyweight ≥60 or <60 kg,respectively)was initiated 3–5 days after DEB-TACE.We evaluated safety,objective response rate(ORR),disease control rate(DCR),progression free survival(PFS),and overall survival(OS).ResultsForty-three patients with advanced HCC who underwent treatment with DEBTACE-lenvatinib were included in this study;65.1%(28/43)were Child-Pugh class A and 34.9%(15/43)were Child-Pugh class B.The median follow-up time was 13.0months(range,3.0-27.0 months).Patients received an average of 2.6 DEB-TACE(range,2 to 4 times);Median duration of administration of lenvatinib was 12.5 months(range,3.0 to 27.0 months).TACE-related adverse events(AEs)occurred in 44.2%(19/43)of patients;only one patient developed a grade 3 AE.Lenvatinib-related AEs of any grade occurred in 90.7%(39/43),and Grade 3 in 30.2%(13/43).Among 13 patients with Grade 3 AEs,12 experienced treatment interruption followed by resumed treatment either at the same dose(n=5;11.6%)or at a reduced dose(n=7;16.3%),one patient experienced discontinued lenvatinib treatment.The ORR and DCR for DEBTACE-lenvatinib were 69.7% and 88.4%,respectively.The median PFS and OS were7.0 months(95% CI: 5.4–8.6 months)and 15.0 months(95% CI: 11.3–18.7 months),respectively.Presence of ascites(HR = 2.890,95% CI: 1.018–8.199;P = 0.046)and extrahepatic metastasis(HR = 2.267,95% CI: 1.044–4.923;P =0.039)were the independent prognostic factors for OS.ConclusionThe combination of DEB-TACE and lenvatinib was safe and effective in patients with advanced HCC. |
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