171P - Transarterial chemoembolization (TACE) plus lenvatinib versus TACE plus sorafenib for hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT): A prospective randomized study

Background

HCC with PVTT portends a worse prognosis. This study compared the efficacy and safety of cTACE plus lenvatinib (cTACE+LEN) to the most commonly utilized regimen, cTACE plus sorafenib (cTACE+SOR), in patients with HCC and PVTT.

Methods

An open-label, single-center, prospective, randomized trial. Patients with previously untreated HCC complicated by type I-IV PVTT were randomized 1:1 to receive cTACE+LEN (LEN orally, 12 or 8 mg/d for bodyweight ≥60 or <60 kg) or cTACE+SOR (SOR orally, 400 mg BID). The primary endpoint was time to progression (TTP; time from randomization to disease progression), secondary endpoints included objective response rate (ORR), overall survival (OS) and toxicity. Tumor response was assessed using mRECIST. Prognostic factors were evaluated with a Cox regression analysis. SPSS v17.0 was used for all analyses.

Results

Between Dec 30, 2018 and May 31, 2020, 64 patients were randomized (cTACE+LEN, n=32; cTACE+SOR, n=32). Patients had a median age of 56 years, a male/female ratio of 13/3, the majority had type I/II PVTT (71.9%; n=46), 34.4% (n=22) had extrahepatic metastasis, and median tumor diameter was 9.0 cm (3.8−21.8). After a median follow-up of 12.5 months, patients in the cTACE+LEN group had a higher median TTP (4.7 vs 3.1 months, HR: 0.55 [95% CI: 0.32–0.97], P=0.037) and numerically higher ORR (50.0 vs 25.0%, P=0.07) and median OS (15.6 [95% CI: 7.7−23.5] vs 10.8 months [95% CI: 8.9−12.7], P=0.15) versus the cTACE+SOR group. A similar incidence of serious adverse events (n=4 vs 2, including gastrointestinal bleeding and hepatic failure), drug withdrawal and dose reduction occurred in the cTACE+LEN and cTACE+SOR groups, and no treatment-related deaths occurred during the study period. Objective response was identified as an independent predictor of favorable TTP (HR: 0.41 [95% CI: 0.22–0.75], P=0.004).

Conclusions

cTACE+LEN was safe, well-tolerated, and had favorable efficacy versus cTACE+SOR for the treatment of advanced HCC with PVTT and large tumor burden. Differences in ORR and OS did not reach statistical significance, which may be due to the limited sample size and requires further study.

Clinical trial identification

NCT04127396.

Editorial acknowledgement

Legal entity responsible for the study

Beijing Ditan Hospital, Capital Medical University, Beijing, China.

Funding

Beijing Hospitals Authority, QML20191805.

Disclosure

All authors have declared no conflicts of interest.