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Review
. 2023 Jun;72(6):1381-1394.
doi: 10.1007/s00262-023-03366-x. Epub 2023 Jan 25.

Hypertransaminasemia in cancer patients receiving immunotherapy and immune-based combinations: the MOUSEION-05 study

Alessandro Rizzo  1 , Veronica Mollica  2   3 , Valentina Tateo  4   5 , Elisa Tassinari  4   5 , Andrea Marchetti  4   5 , Matteo Rosellini  4   5 , Raffaele De Luca  6 , Matteo Santoni #  7 , Francesco Massari #  4   5
Affiliations
Review

Hypertransaminasemia in cancer patients receiving immunotherapy and immune-based combinations: the MOUSEION-05 study

Alessandro Rizzo et al. Cancer Immunol Immunother. 2023 Jun.

Abstract

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.

Keywords: ALT; Cancer; Hypertransaminasemia; Immune checkpoint inhibitors; Immunotherapy; Liver toxicity.

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Conflict of interest statement

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

Figures

Fig. 1
Fig. 1
Forest plot of comparison between ICIs monotherapy and immune-based combinations versus control arm in cancer patients; the outcome was the relative risk (RR) of grade 3–4 AST increase
Fig. 2
Fig. 2
Forest plot of comparison between ICIs monotherapy and immune-based combinations versus control arm in cancer patients; the outcome was the relative risk (RR) grade 3–4 ALT increase
See this image and copyright information in PMC

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