Transarterial chemoembolization (TACE) can improve survival when added to lenvatinib in patients with advanced hepatocellular carcinoma (HCC), according to research published in the Journal of Clinical Oncology.
In the phase 3 LAUNCH trial, adding TACE to lenvatinib improved both progression-free survival (PFS) and overall survival (OS).
The LAUNCH trial (ClinicalTrials.gov Identifier: NCT03905967) included 338 patients from China who had advanced HCC. They had either received no prior treatment or had recurrence after radical resection. Patients were randomly assigned to receive lenvatinib plus TACE (n=170) or lenvatinib monotherapy (n=168).
The median age at baseline was 54 years in the TACE arm and 56 years in the monotherapy arm. Most patients had a primary tumor (92.4% and 84.5%, respectively), were men (81.8% and 78.6%), and had hepatitis B (87.1% and 85.7%). More than half of patients had extrahepatic spread (55.3% and 56.5%, respectively).
After study treatment, 26 patients in the TACE arm underwent curative surgical resection, and 2 patients had a pathological complete response. Three patients in the monotherapy arm underwent curative resection, but none had a pathological complete response.
The median follow-up was 17 months. The median OS was 17.8 months with TACE plus lenvatinib and 11.5 months with lenvatinib alone (hazard ratio [HR], 0.45; 95% CI, 0.33-0.61; P <.001).
The 6-month OS rate was 95.9% in the TACE arm and 87.4% in the monotherapy arm. The 12-month OS rate was 81.5% and 46.9%, respectively. The 24-month OS rate was 26.1% and 17.8%, respectively.
The median PFS was 10.6 months with TACE plus lenvatinib and 6.4 months with lenvatinib monotherapy (HR, 0.43; 95% CI, 0.34-0.55; P <.001). The 6-month PFS rate was 88.2% and 54.8%, respectively. The 12-month PFS rate was 39.2% and 14.3%, respectively.
The objective response rate was 54.1% with TACE plus lenvatinib and 25.0% with lenvatinib alone (P <.001), according to modified RECIST criteria. The complete response rate was 2.9% and 0.6%, respectively.
Grade 3-4 adverse events that were more frequent in the TACE arm than in the monotherapy arm included ALT elevation (17.6% vs 1.2%, P <.001), AST elevation (22.9% vs 1.8%, P <.001), and hyperbilirubinemia (9.4% vs 3.0%, P =.014).
Grade 3-4 hypertension was common in both arms, occurring in 20.6% of patients in the TACE arm and 19.6% of patients in the monotherapy arm.
Taking these results together, the researchers concluded that TACE plus lenvatinib is safe and effective for this patient population.
Disclosures: One study author declared an affiliation with GenomiCare. Please see the original reference for details.
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