Abstract 88P
Background
The triple combination therapy of HAIC combined with len. and ICIs showed promising results for advanced uHCC comparing with duplex treatment. However, for high tumor-burden lesions, the triple combination therapy is still insufficient in reduce tumor burden without TAE. This study aimed to assess the efficacy and safety of quadruple combination therapy comparing to the triple combination therapy.
Methods
This retrospective study comprised consecutive patients who had a primary uHCC with PVTT and high tumor-burden (max nodule diameter >10cm) from Jan 2019 to Feb 2022 in four Chinese medical centers. These pats were treated with either quadruple combination therapy (TAE, HAIC, len and tis; THLP group) or triple combination therapy (HAIC, len and tis; HLP group). HAIC involved oxaliplatin, fluorouracil, and leucovorin (FOLFOX). Efficacy was evaluated according to OS, PFS, ORRDCR. Besides, treatment-related AEs were compared.
Results
In total, 100 patients were included in this study: 50 patients in the THLP group and the remaining 50 patients in the HLP group respectively, which resulted in a 1:1 ratio between two groups. The median follow-up was 10.8 months (range, 4.6-20.2 m). The THLP group showed OS (14.1 vs 11.3 m; hazard ratio [HR] 0.60, 95% CI, 0.37-0.99; p=0.044), PFS (5.6 vs 4.4 month; HR 0.63, 95% CI 0.40-0.98; p=0.039), and a higher objective response rate (mRECIST: 72% vs 52%, p=0.039; RECIST 1.1: 60% vs 40%, p=0.046) than the HLP group. As for the DCR, though there was no significant difference, the THLP group was higher than the HLP group (mRECIST: 88% vs 76%, p=0.118; RECIST 1.1: 86% vs 72%, p=0.086). Grade 3/4 treatment-related AEs were more frequent in the THLP group than in the HLP group including abdominal pain (34% vs 18%), Nausea (36% vs 22%), and elevated transaminases (10% vs 2%), but there AEs were completely controllable and no treatment-related death happened.
Conclusions
Additional TAE to triple combination therapy of HAIC, len and tis might improve prognosis compared with triple combination therapy and had accepted toxic effects.
Legal entity responsible for the study
The authors.
Funding
BeiGene Ltd.
Disclosure
All authors have declared no conflicts of interest.