Abstract
BackgroundWe performed a systematic review and meta-analysis to evaluate the risks of cardiac adverse events in solid tumor patients treated with monotherapy of immune checkpoint inhibitors (ICIs) or combined therapy of ICIs plus chemotherapy.MethodsEligible studies were selected through the following databases: PubMed, Embase and clinical trials (https://clinicaltrials.gov.) and included phase III/IV randomized controlled trials (RCTs) involving patients with the solid tumor treated with ICIs. The data was analyzed by using Review Manager (version5.3), Stata (version 15.1).ResultsAmong 2,551 studies, 25 clinical trials including 20,244 patients were qualified for the meta-analysis. Compared with PD-1 inhibitor (nivolumab) or CTLA-4 inhibitor (ipilimumab), PD-1 inhibitor (nivolumab) plus CTLA-4 inhibitor (ipilimumab) combined therapy showed significant increase in grade 5 arrhythmology (OR 3.90, 95% CI: 1.08–14.06, p = 0.603). PD-1 inhibitor plus chemotherapy show significant increase in grades 1–5 myocardial disease (OR 5.09, 95% CI: 1.11–23.32, p = 1.000). Compared with chemotherapy, PD-1 inhibitor (nivolumab) or CTLA-4 inhibitor (ipilimumab), PD-1 inhibitor (nivolumab) plus CTLA-4 inhibitor (ipilimumab) combined therapy show significant increase in grades 1–5 arrhythmology (OR 2.49, 95% CI: 1.30–4.78, p = 0.289).ConclusionsOur meta-analysis demonstrated that PD-1 inhibitor plus CTLA-4 inhibitor can result in a higher risk of grade 5 arrhythmology in comparison with PD-1/CTLA-4 inhibitor alone, and a higher risk of grade 5 arrhythmology in comparison with chemotherapy. PD-1 inhibitor plus chemotherapy treatment could increase the risk of all-grade myocardial disease compared with chemotherapy. However, in most cases, there was no significant increase of risks of cardiovascular toxicity in PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor plus chemotherapy compared with chemotherapy alone.
Highlights
The progression of immunotherapy have considerably changed cancer treatment, and improved the clinical prognosis of many cancer patients
A list of immune checkpoint inhibitors (ICIs) have been approved by Food and Drug Administration(FDA), including PD-L1 inhibitors, CTLA4 inhibitor, and PD-1 inhibitors etc., which were applied to treatable tumors including melanoma, Hodgkin’s lymphoma, non-smallcell lung cancer, renal cell carcinoma, bladder, head and neck cancer, liver, gastric cancer and microsatellite instability high or DNA mismatch repair-deficient colorectal cancer [2], since immune checkpoints play pivotal roles in maintaining homeostasis of normal tissues, their therapeutic blockade can unavoidably cause side effects to the patients, termed as immune-related adverse events
The medical subject heading (MeSH) terms included for searching the relevant studies containing the following keywords and terms: one term that refers to cancer, one term indicating the ICIs, and one term related to randomized controlled trials, connected by “and”
Summary
The progression of immunotherapy have considerably changed cancer treatment, and improved the clinical prognosis of many cancer patients. Cardiotoxicity has been found following cancer-related treatments such as chemotherapy and targeted therapy, which sometimes, like the myocarditis, can be fatal. The risks of immune-related cardiac toxicity in cancer patients treated with ICIs were systematically evaluated, which was supposed to help better understand the cardiac harmness of ICIs and provide a reference for the rational use and safety evaluation of ICIs in clinical practice. We performed a systematic review and meta-analysis to evaluate the risks of cardiac adverse events in solid tumor patients treated with monotherapy of immune checkpoint inhibitors (ICIs) or combined therapy of ICIs plus chemotherapy
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