Abstract 945P
Background
Multiple studies had demonstrated that surgical resection provided better overall survival (OS) than other treatments even for BCLC stage B or C hepatocellular carcinoma (HCC) patients in China. However, there was no standard adjuvant therapy to decrease the risk of post-operative tumor relapse. Several studies showed transcatheter arterial chemoembolization (TACE) as adjuvant therapy could reduce tumor recurrence and prolong the disease-free survival (DFS) and OS. However, its effect is not satisfactory. Here, we reported updated results from Lance study which 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
The criteria of HCC patients with high postoperative recurrence risk included: accompanied with gross vascular or bile duct invasion, 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 incomplete capsules. The patients were divided into two groups, the lenvatinb combined with TACE (Len+TACE) group and the TACE group.
Results
The cohorts have been expanded to 184 patients in all. While 92 patients in the Len+TACE group and 92 in the TACE group. The baseline clinicopathological characteristics between the two groups were well balanced. The media DFS was 17.0 months (95% CI 12.0-24.0) in Len+ TACE group, which was significantly longer than that of TACE group (9.0 months, 95% CI 7.0-14.0, P=0.0228; HR 0.6, 95% CI 0.4-1.0). The most common grade 3 or 4 adverse events (frequency≥5%) were hypertension (19.6%), diarrhea (15.2%), gingiva bleeding (13.0%), hand-foot skin reaction (8.7%), joint pain (5.4%) and impaired liver function (5.4%) in Len+TACE group.
Conclusions
In the expanded cohorts, adjuvant lenvatinib in combination with TACE showed prolonged DFS over TACE alone for patients with high recurrence risk after resection. And there were no unexpected safety signals in the combination group.
Clinical trial identification
NCT03838796.
Editorial acknowledgement
Legal entity responsible for the study
Lun-Xiu Qin.
Funding
Ministry of Science and Technology, China.
Disclosure
All authors have declared no conflicts of interest.