Transarterial chemoembolization plus lenvatinib versus transarterial chemoembolization plus sorafenib as first‐line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A prospective randomized study

Abstract

BACKGROUND:The efficacy and safety of transarterial chemoembolization (TACE) plus lenvatinib in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT) have not been evaluated. METHODS: In this open-label, single-center, randomized trial (ClinicalTrials.gov identifier: NCT04127396), participants with previously untreated HCC and type I-IV PVTT were randomized 1:1 to receive TACE plus lenvatinib (arm L; orally once daily, 12 mg for body weight ≥60 kg or 8 mg for body weight <60 kg) or TACE plus sorafenib (arm S; 400 mg orally twice daily in 28-day cycles). The primary end point was time-to-progression (TTP; time from randomization to disease progression) and secondary end points included objective response rate and toxicity. Prognostic factors were evaluated using a multivariable Cox proportional hazards model. RESULTS: Between December 30, 2018 and May 31, 2020, 64 patients were randomized (arm L, n = 32; arm S, n = 32); most patients had type I/II PVTT (71.9%), and the median target tumor diameter was 9.8 cm (range, 3.8-21.8). After a median follow-up of 16.1 months, patients in arm L had a higher median TTP (4.7 vs 3.1 months; hazard ratio [HR], 0.55; 95% CI, 0.32-0.95; P = .029) and objective response rate (53.1% vs 25.0%, P = .039) versus arm S. Multivariable analysis showed that TACE plus lenvatinib was significantly associated with higher TTP versus TACE plus sorafenib (HR, 0.50; 95% CI, 0.28-0.90; P = .021). Comparable safety profiles were observed in arms L and S. CONCLUSIONS: TACE plus lenvatinib was safe, well tolerated, and had favorable efficacy versus TACE plus sorafenib in patients with advanced HCC with PVTT and large tumor burden. Cancer 2021;127:3782-3793.

TACE Plus Lenvatinib Versus TACE Plus Sorafenib for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Prospective Cohort Study

“…Our results revealed that TACE-L achieved significantly better benefits with respect to PFS, OS, and ORR than TACE-S in HCC patients with PVTT. These results are similar to those of a previously published study ( 15 ), in which TACE-L was better than TACE-S in HCC with PVTT in terms of median TTP (4.7 vs. 3.1 months, p = 0.037) and numerically better median OS (15.6 vs. 10.8 months, p = 0.15) and ORR (50.0 vs. 25.0%, p = 0.07). In our study, we did not observe any significant differences in either OS or PFS in the entire cohort but only after PSM.…”

“…Ding et al. have reported TACE-L vs. TACE-S in HCC patients ( 15 ). Our study offers a comparison of the efficacy between TACE-L and TACE-S in HCC patients with PVTT.…”

The Significance of Transarterial Chemo(Embolization) Combined With Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma in the Era of Systemic Therapy: A Systematic Review

“…On the other hand, systemic therapy is the key to improve the long-term prognosis, but unsatisfactory LC will impair the long-term survival advantage. Preclinical studies have identified the synergistic effect of TACE/HAIC and systemic therapy ( 20 , 21 ), which was also confirmed in practice of the combination of TACE and sorafenib ( 22 ), TACE and lenvatinib ( 23 ), HAIC and sorafenib ( 24 ), and HAIC plus lenvatinib and toripalimab ( 25 ), but it is not the end.…”

Efficacy and Safety of TACE Combined With Lenvatinib Plus PD-1 Inhibitors Compared With TACE Alone for Unresectable Hepatocellular Carcinoma Patients: A Prospective Cohort Study

“…In this triple combination group, patients achieved a 67.9% ORR according to the mRECIST criteria, which significantly higher than that of dual combination, with an ORR of 33.2-46% ( 18 , 19 , 28 ) in PD-1/PD-L1 inhibitors combined with antiangiogenics, and 27.8-53.1% ( 29 , 30 ) in TACE combined with Lenvatinib. It has been found that the application of TACE alongside TKI and ICI resulted in more synergistic antitumor effects.…”