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ABSTRACT
Background
Despite all the improvements achieved over the last decade, the use of immune checkpoint inhibitors (ICIs) has been associated to a wide range of adverse drug events, which are frequently markedly different from those observed with cytotoxic chemotherapy and targeted therapies, such as sorafenib.
Research design and methods
We performed a meta-analysis with the aim to compare grade 3/4 treatment-related adverse events (TRAEs), grade 5 TRAEs, serious TRAEs, and TRAEs leading to discontinuation in ICIs versus sorafenib across phase III clinical trials of first-line treatment for advanced hepatocellular carcinoma (HCC).
Results
Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Patients treated with ICIs showed higher risk of serious TRAEs (OR 1.48, 95% CI = 1.16–1.9) while sorafenib treatment was associated with higher risk of TRAEs leading to discontinuation (OR 0.65, 95% CI = 0.48–0.89). No differences in grade 3/4 TRAEs and grade 5 TRAEs.
Conclusions
Beyond activity and efficacy, careful consideration should be given to toxicity while choosing the appropriate first-line treatment in HCC.
Article highlights
According to our results, HCC patients with unresectable disease receiving ICIs presented higher risk of all-grade pruritus while sorafenib treatment was associated with higher risk of diarrhea and HFSR.
No statistically significant differences were observed in terms of fatigue, AST increase, rash, hypertension, and decreased appetite.
Despite the several limitations affecting our analyses, ICIs appear feasible in advanced HCC, being endowed with an acceptable safety profile.
Declaration of interests
The authors have 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.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contribution statement
Conception and design: A Rizzo, G Brandi. Acquisition of data: All authors. Analysis and interpretation of data: A Rizzo. Drafting of the manuscript: A Rizzo, R Carloni, AD Ricci. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: A Rizzo. Obtaining funding: None. Administrative, technical, or material support: All authors. Supervision: G Palmiotti, G Brandi.