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Hypertransaminasemia in cancer patients receiving immunotherapy and immune-based combinations: the MOUSEION-05 study
Alessandro Rizzo1, Veronica Mollica2,3, Valentina Tateo4,5
1Struttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico Globale del Paziente Oncologico "Don Tonino Bello", Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Istituto Tumori Giovanni Paolo II-Bari, Viale Orazio Flacco 65, 70124, Bari, Italy.
Background:
The antitumor efficacy of immune checkpoint inhibitors (ICIs) has increasingly emerged during the last few years. However, there is a need to identify the safety profile of these agents more comprehensively, including liver toxicity.
Materials And Methods:
Herein, we performed a meta-analysis to assess the risk of all-grade and grade 3-4 hypertransaminasemia in cancer patients receiving ICIs-as monotherapy or in combination with other anticancer agents. All the relevant trials were retrieved through EMBASE, Cochrane Library, and PubMed/Medline databases; eligible studies were selected according to PRISMA statement. The pooled relative risk (RR) and 95% confidence interval (CI) were extracted.
Results:
Fifty-nine studies were included. The pooled RRs for all-grade AST and ALT increase were 1.45 (95% CI 1.26-1.67) (Supplementary Fig. 3) and 1.51 (95% CI 1.29-1.77) in patients receiving ICIs monotherapy and immune-based combinations compared to control treatment, respectively. The pooled RRs for grade 3-4 AST and ALT increase were 2.16 (95% CI 1.77-2.64) and 2.3 (95% CI 1.91-2.77).
Conclusions:
According to our results, ICIs monotherapy and immune-based combinations were associated with higher risk of all-grade and grade 3-4 hypertransaminasemia. Monitoring liver function should be recommended in cancer patients treated with ICIs monotherapy or immune-based combination, and in case of underlying liver disease, a careful risk-benefit assessment appears as a mandatory need.
Insights
Immune checkpoint inhibitors (ICIs) increase the risk of liver toxicity, including elevated liver enzymes. Careful monitoring of liver function is crucial for cancer patients undergoing ICI therapy, especially those with pre-existing liver conditions.
Area of Science:
- Oncology
- Immunotherapy
- Hepatology
Background:
- Immune checkpoint inhibitors (ICIs) demonstrate significant antitumor efficacy.
- Comprehensive safety profiling of ICIs, particularly concerning liver toxicity, is essential.
- Hypertransaminasemia is a notable adverse event associated with ICI treatment.
Approach:
- A meta-analysis was conducted to evaluate the risk of all-grade and grade 3-4 hypertransaminasemia.
- Relevant clinical trials were systematically retrieved from EMBASE, Cochrane Library, and PubMed/Medline databases.
- Pooled relative risks (RR) and 95% confidence intervals (CI) were calculated to assess the association between ICIs and liver enzyme elevations.
Key Points:
- The meta-analysis included fifty-nine studies.
- ICI monotherapy and combination therapies were associated with increased risk of all-grade AST and ALT elevation (RR 1.45-1.51).
- A higher risk of grade 3-4 AST and ALT increase was observed with ICIs (RR 2.16-2.3).
Conclusions:
- Both ICI monotherapy and immune-based combinations elevate the risk of hypertransaminasemia.
- Regular liver function monitoring is recommended for cancer patients receiving ICIs.
- A thorough risk-benefit assessment is mandatory for patients with underlying liver disease undergoing ICI treatment.
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