Transarterial Chemoembolization Added to Lenvatinib Improves Clinical Outcomes in Hepatocellular Carcinoma

Combined treatment with transarterial chemoembolization (TACE) and lenvatinib improves clinical outcomes vs lenvatinib alone for patients with advanced hepatocellular carcinoma, according to findings from an interim analysis of a phase 3 trial. This benefit was found to be consistent across multiple patient subgroups. The study authors noted, “although lenvatinib represents a standard first-line therapeutic option for advanced hepatocellular carcinoma, survival rates in this patient population still remain poor.”

This open-label, parallel group, phase 3 trial enrolled 338 patients with advanced primary hepatocellular carcinoma or initial recurrent advanced hepatocellular carcinoma following radical resection who had not received any systemic cancer therapy from 12 hospitals in China between June 2019 and July 2021. Patients were randomized on a 1:1 basis to receive either lenvatinib (12 mg if body weight ≥ 60 kg; 8 mg if bodyweight < 60 kg) orally once daily (n = 168) or lenvatinib followed by TACE 1 day after lenvatinib administration which was repeated upon incomplete necrosis and tumor regrowth (n = 170). TACE was administered by either drug-eluding beads or conventional methods. The primary end point was overall survival (OS).

At the data cutoff date of October 10, 2021, the median follow-up duration was 17 months. The median OS of the lenvatinib plus TACE group  was 17.8 months (95% confidence interval [CI], 16.1 to 19.5) vs 11.5 months (95% CI, 10.3 to 12.7) in the lenvatinib alone group (hazard ratio [HR], 0.45; P <.001). The median progression-free survival (PFS) of the lenvatinib plus TACE group was 10.6 months (95% CI, 9.5 to 11.7), compared to 6.4 months in the lenvatinib group (95% CI, 5.8 to 7.0; HR, 0.43; P <.001).

In addition, the objective response rate was higher in the lenvatinib plus TACE group (54.1% vs 25% in the lenvatinib group, as determined by mRECIST; P <.001). According to multivariable analysis, both portal vein tumor thrombus and treatment allocation were independent risk factors for OS. In the lenvatinib plus TACE group, there was no significant difference found in median OS, PFS, or local tumor response between the two methods of TACE.

In the lenvatinib plus TACE group 44.6% of patients received a dose reduction due to severe adverse events compared to 52.9% in the lenvatinib group (P = .127).

Study authors concluded that the addition of TACE to lenvatinib “is a potential first-line treatment for patients with advanced [hepatocellular carcinoma].”

Source:

Peng Z, Fan W, Zhu B, et al. Lenvatinib combined with transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma: A phase III, randomized clinical trial (LAUNCH). J Clin Oncol. Published online August 3, 2022. doi:10.1200/JCO.22.00392