Abstract 191P
Background
In the last few years, first-line systemic therapy for advanced hepatocellular carcinoma (HCC) has rapidly evolved with the introduction of lenvatinib and later of immune checkpoint inhibitors, thereby making the choice of second-line (2L) treatments more difficult. Although sorafenib is commonly employed as a 2L option, there is a lack of comprehensive data supporting its efficacy in this setting. This study aims to evaluate the effectiveness of sorafenib as 2L therapy and factors associated with following first-line treatment failure in patients with advanced HCC.
Methods
We conducted a comprehensive retrospective multicenter study, including 81 patients with advanced HCC from 12 European centers who received a systemic 2L therapy with sorafenib. Overall survival (OS), progression-free survival (PFS) (both from start sorafenib), therapy response and toxicity were evaluated. Factors influencing OS were analyzed univariate and multivariate to identify potential predictors of treatment efficacy.
Results
Median OS observed in the cohort was 7.4 months (95% CI: 6.6 - 13.6), with a median PFS of 3.7 months (95% CI: 3.0 - 4.8). The univariate analysis identified several factors significantly associated with improved OS, including lower ECOG performance status, Child-Pugh class A (CP A), early BCLC stage, and lower AFP levels at the initiation of sorafenib treatment. In contrast, there was no evidence that etiology or ALBI-score influences OS. Multivariate analysis revealed the best median OS for patients with CP A and AFP levels < 400 ng/ml (15.5 months). Notably, adverse events (AE) of grade ≥3 were reported in 59.4% of patients, with hand-foot syndrome (14.5%), liver failure (13%), and diarrhea (11.6%) being the most common.
Conclusions
Sorafenib, as a 2L treatment in a real-world European cohort of advanced HCC patients, demonstrates only modest efficacy with moderate tolerability. Identifying predictive factors for response and survival could help refining patient selection for this treatment strategy. This study contributes to the understanding of the role of sorafenib in the 2L setting and underscores the need for further research to optimize treatment algorithms for advanced HCC.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Vogel: Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, BeiGene, Boehringer Ingelheim Mannheim, BMS, Eisai, Incyte, Ipsen, MSD, Pierre Fabre, Roche, Servier, Tahio. U. Ehmer: Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, MSD, Eisai; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eisai, MSD, the FALK foundation, Ipsen, Novartis. M. Pinter: Financial Interests, Personal, Invited Speaker: Bayer, BMS, Eisai, Ipsen, Lilly, MSD, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, BMS, Eisai, Ipsen, Lilly, MSD, Roche; Financial Interests, Institutional, Research Grant: AstraZeneca, Bayer, BMS, Eisai, Roche; Financial Interests, Personal, Other, Travel support: Bayer, BMS, Ipsen, Roche. M.A. Gonzalez Carmona: Financial Interests, Personal, Advisory Board: Roche, Eisai, MSD, BMS, AstraZeneca, Servier. All other authors have declared no conflicts of interest.