Risk of adverse events in advanced hepatocellular carcinoma with immune checkpoint therapy: A systematic review and meta-analysis - 22/11/20
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Highlights |
• | What is already known on this subject? Immune checkpoint therapy has shown durable antitumor responses in advanced hepatocellular carcinoma (AHCC) patients, and several key clinical trials are now ongoing. However, to our knowledge, the potential risk of adverse events (AEs) in AHCC with immune checkpoint therapy have not been evaluated. |
• | What are the new findings? Immune checkpoint therapy significantly increases the risk of AEs in AHCC patients. The risk of grade≥3 AEs is associated with Child-Pugh classification. And the risk of AEs in AHCC patients with immune checkpoint therapy may be independent on their hepatitis status. |
• | How might it impact on clinical practice in the foreseeable future? For AHCC patients treated with immune checkpoint therapy, it is necessary to strengthen the monitoring of patients’ medication (especially AST and ALT). |
Summary |
Aims |
To evaluate risk of adverse events (AEs) in advanced hepatocellular carcinoma (AHCC) with immune checkpoint therapy in this setting.
Methods |
A systematic search of original articles published until November 2019 was performed using PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials. And a meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
Results |
A total of eight studies, including 597 patients, met the eligibility criteria. The median cohort size of patients was 75 (range: 18–267). The pooled incidence rates of grade≥3 AEs and fatal adverse events (FAEs) at last follow-up were 20.87 per 100 person-years (95% CI: 11.00–39.59, I2=91.0%) and 4.98 per 100 person-years (95% CI: 1.83–13.56, I2=82.8%). Subgroup analyses showed that pembrolizumab had a lower risk of grade≥3 AEs, but a higher risk of FAEs, when compared with nivolumab and tremelimumab. Meta-regression showed significant correlation between grade≥3 AEs rate and proportion of Child–Pugh A stage. Fatigue (16.9%), adrenal insufficiency (8.5%) and rash (6.8%) were involved in common non-laboratory AEs.
Conclusions |
Immune checkpoint therapy significantly increases the risk of AEs in AHCC patients. And the risk of grade≥3 AEs is associated with Child–Pugh classification. Future retrospective analyses and prospective cohort studies are warranted to evaluate the safety of immune checkpoint therapy in AHCC.
El texto completo de este artículo está disponible en PDF.Keywords : Immune checkpoint therapy, Advanced hepatocellular carcinoma, Adverse events
Abbreviations : AEs, AHCC, AST, ALT, CTLA-4, CTCAE, FAEs, HCC, NR, NOS, 95% CIs, OS, PY, PFS, PD-L1, PD-1
Esquema
Vol 44 - N° 6
P. 845-854 - novembre 2020 Regresar al número
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