Adjuvant lenvatinib in combination with TACE for hepatocellular carcinoma patients with high risk of postoperative relapse (LANCE): Interim results from a muticenter prospective cohort study.

4580 Background: Surgical resection was the main treatment for hepatocellular carcinoma (HCC) in China. Multiple clinical studies had demonstrated that the overall survival (OS) of the surgical resection group was significantly better than the transcatheter arterial chemoembolization (TACE) or radiotherapy group even for HCC patients with BCLC stage B or C. There was no standard adjuvant therapy for HCC patients to decrease the post-operative tumor relapse. For HCC patients with high recurrence risk, TACE significantly reduced tumor recurrence, prolonged the disease free survival (DFS) and OS, and was recommended as the adjuvant therapy. However, its effect is not very satisfactory. The purpose of this study was to assess the efficacy and safety of lenvatinib in combination with TACE versus TACE alone as adjuvant therapy in HCC patients with high recurrence risk after resection. Methods: This is a muti-center prospective cohort study. The criteria of HCC patients with high postoperative recurrence risk included: accompanied with gross vascular or bile duct invasion (tumor thrombi in portal vein, hepatic vein or bile duct); or tumor rupture or invasion of adjacent organs; or grade 2 of microvascular invasion (MVI) (M2) along with the tumor number more than 3 or the maximum diameter of tumor larger than 8cm or tumor showed invasive growth with unclear boundaries and imcomplete capsules. The patients were divided into two groups, the lenvatinb (8mg qd for weights < 60kg and 12mg qd for weights≥60kg) in combination with TACE (Len+TACE) group and the TACE group. Results: A total of 90 patients were enrolled into the study, while 45 patients in the Len+TACE group and 45 in TACE group. The media age was 52 years (range from 23 to 73 years). Most patients were males (82.2%) and 66 patients had HBV background (73.3%). There were no significant differences between the two groups in the baseline clinicopathological characteristics including gender, age, HBV background, liver cirrhosis, liver function, tumor characteristic and AFP level. The media DFS was 12.0 months (95% CI 8.0-NA) in the Len+ TACE group, which was longer than that of TACE group (8.0 months, 95% CI 6.0-12.0, P = 0.0359; HR 0.5, 95% CI 0.3-1.0). The most common grade 3 or 4 adverse events were hypertension (11.1%) and diarrhea (7.7%) in the Len+TACE group. Conclusions: Lenvatinib in combination with TACE was effective and safe as adjuvant therapy, which can prolong the DFS of HCC patients with high recurrence risk after resection. Clinical trial information: NCT03838796 .