Abstract 989P
Background
The combination of lenvatinib and anti-PD-1 antibody (combination therapy) is effective in terms of tumor response rate and progression-free survival in patients with advanced hepatocellular carcinoma (HCC). The combination therapy has been used in patients with advanced HCC following a pre-designed protocol to observe efficacy and adverse effects in our department since 2018. We aim to assess the short-term changes in hepatic function and occurrence of liver-related AEs associated with the combination therapy.
Methods
From August 2018 to March 2020, 84 patients were treated with the combination therapy. 49 patients received 4 or more consecutive courses with at least one efficacy and safety assessment were eligible for in this study. The median age was 56 years, and male: female ratio was 45:4. 48 patients were child-Pugh A and only one patient was Child-Pugh B.
Results
44 (89.8%) patients developed liver-related AEs during four courses of treatment (33 pts of grade 1, 8 pts of grade 2 and 3 pts of grade 3). The overall change of ALBI value varied from -2.645±0.397 to -2.624±0.5. There was a significant difference in the trend of changes in liver function between patients at grade 1 and grade 2 ALBI baseline (P=0.046), with grade 1 patients getting worse and grade 2 patients getting better. ALBI value of the patients with baseline ALBI grade 1 increased from -2.938±0.271 to -2.675±0.46 throughout the evaluation cycle (P=0.006), while that of patients with grade 2 ALBI decreased from -2.313±0.211 to -2.566±0.547. (P=0.036) The ALBI value increased in 57.7%, 73.1%, 57.7% and 61.5% of patients with baseline ALBI grade 1 after the 1st, 2nd, 3rd and 4th medication, while only 34.8%, 21.7%, 26.1% and 21.7% of patients with grade 2, respectively. There was no significant difference in the trend of liver function changes between patients with PR and CR and patients with SD and PD (P=0.541). ALBI value increased from -2.954±0.319 to -2.677±0.494 after four medications (P=0.026) in patients with baseline ALBI grade 1 who had SD or PD, while there was no statistically significant change of ALBI value in those with CR or PR.
Conclusions
Liver function was not affected by the combination therapy using lenvatinib and anti-PD -1 antibody.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.