Cardiovascular adverse events after CAR-T, BiTEs and TILs therapies: a systematic review and meta-analysis
Bibliographic record
Abstract
Abstract Introduction Cancer immunotherapy with chimeric antigen receptor T-cells (CAR-T), tumor-infiltrating lymphocyte (TILs) therapy, or bispecific T-cell engagers (BiTEs) has significantly improved cancer outcomes. However, these treatments are associated with a range of adverse cardiovascular (CV) events. Purpose Our objective was to provide a comprehensive assessment of cardiovascular adverse event rates associated with these immunotherapies through a systematic review and meta-analysis of published studies in adult patients with cancer. Methods We systematically searched PubMed, MEDLINE, and EMBASE, identifying studies from January 1, 2000 to June 26, 2024. We included studies that reported CV events in patients receiving CAR-T, BiTEs, or TILs. Studies were categorized as either clinical trials or observational studies, with the latter comprising retrospective cohorts, prospective cohorts, and registry studies. For each outcome, we conducted a random-effects meta-analysis of proportions or incidence rates. In this abstract, we report on heart failure, arrhythmias, and cytokine release syndrome (CRS). Our meta-analyses of proportions focused on incidence at 30-days and 90-days. Meta-analyses of incidence rate focused on overall incidence rates per 1000 patient days followed (for studies with varying follow-up periods – patient days calculated with the total sample size and average length of follow-up reported per study). Results We identified 107 studies for inclusion: 79 CAR-T studies (8044 patients), 18 BiTEs studies (5633 patients), and 10 TILs studies (335 patients). The analysis predominantly included clinical trials (n=79), with a smaller proportion of observational studies. CRS: CAR-T therapy exhibited the highest rates of CRS at 85.7% (95% CI, 78.1%-94.0%), compared to TILs at 0.8% (95% CI, 0.0%-11.9%), and BiTEs at 7.7% (95% CI, 3.7%-16.2%) at 30 days. Observational studies reported a higher incidence of CRS within the first 30 days compared to clinical trials. No significant differences were observed in longer-term rates. Heart Failure: Heart failure had a 30-day incidence of 1.1% (95% CI, 0.6%-2.0%) and a 90-day incidence of 1.4% (95% CI, 0.7%-2.7%), with an incidence rate of 1 per 10,000 patient-days. No major differences were found between different therapy types or study designs. Arrhythmia: Arrhythmia had a 30-day incidence of 4.6% (95% CI, 2.3%-9.1%) and a 90-day incidence of 1.5% (95% CI, 0.7%-3.6%), with an incidence rate of 2 per 10,000 patient-days. No significant differences were observed between therapy types; however, in terms of design, higher rates were reported in observational studies only at 30 days. Conclusion Our meta-analysis provides an estimate of the CRS in patients receiving various immunotherapies and the incidence of clinically important CV events. Although arrhythmias were more common that heart failure, the overall incidence at 30 and 90 days of follow-up remains low.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".