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Efficacy and safety of immune checkpoint inhibitors in older HCC patients: A real-world study
Background
To explore efficacy and safety of Immune Checkpoint Inhibitors (ICIs) in patients ≥ 75 years old in a real-world situation.
Methods
We consecutively enrolled HCC patients for 75 years old or elder who have received ICIs from September 2019 to October 2021 in the Fifth Centre of People's Liberation Army General Hospital. ECOG, Child-Pugh and BCLC stage were evaluated in baseline. Objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and adverse events (AEs) were recorded in accordance with RECIST v1.1 and CTCAE v5.0.
Results
24 eligible aged patients were finally enrolled in our study. In criteria of latest BCLC staging, nearly all patients were in BCLC-C. 17 were in Child-Pugh A and the other 7 were in Child-Pugh B. At data cut-off (2022-03), following median following-up of 10.1 months, ORR was 8.3% (95%CI: 0 -19%) and DCR was 54.2% (95%CI: 34%-74%). PR (partial response), SD (stable disease) and PD (progressive disease) were observed in 2, 11 and 9 patients. No CR (complete response) were found and 2 patients could not be evaluated. Median PFS was 6.3 months and median OS was 17.0 months. 3-month and 6-month PFS rate were 67.5% and 50.0%. 3-month, 6-month and 12-month OS rate were 82.5%, 73.3% and 55.7% respectively. Progression of disease were the main reason for discontinuation of ICIs (14 of 24), following severe AE (SAE). Total 4 patients stopped ICIs treatment due to SAE. 3 patients developed drug-induced hepatic injury and 1 patient suffered from uncontrollable infection.
Conclusions
Though some older patients with HCC could benefit from ICIs therapy. Application of ICIs in these patients has to be cautious.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosures
All authors have declared no conflicts of interest.
