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Communication from the ISTH SSC Subcommittee on Hemostasis and Malignancy: A meta-analysis to assess the risk of bleeding and thrombosis following CAR T-cell therapy.

BACKGROUND: Chimeric antigen receptor T cell (CAR T-cell) therapy is increasingly utilized for treatment of hematologic malignancies. Hematologic toxicities including thrombosis and bleeding complications have been reported. Accurate estimates for thrombotic and bleeding outcomes are lacking.

METHODS: We searched MEDLINE, EMBASE, and Cochrane CENTRAL up to February 2022 for studies reporting thrombotic or bleeding outcomes in patients receiving CAR T-cell therapy. Pooled event rates were calculated using a random-effects model. We performed subgroup analyses stratified by follow up duration, CAR T-cell target antigen, and underlying hematologic malignancy.

RESULTS: We included 47 studies with a total 7040 patients. High heterogeneity between studies precluded reporting of overall pooled rates of thrombotic and bleeding events. In studies with follow-up duration of ≤6 months, the pooled incidence of venous thrombotic events were 2.4% (95% CI 1.4-3.4, I2 = 0%) per patient-month whereas the rate was 0.1% (95% CI 0-0.1, I2 = 0%) per patient-month for studies with longer follow-up periods (> 6 months). The pooled incidences of any bleeding events per patient-month in studies with follow-up duration of ≤6 months and > 6 months were 1.9% (95% CI: 0.6-3.1, I2 = 78%) and 0.3% (95% CI: 0-0.8, I2 = 40%) respectively. Secondary analyses by CAR T-cell target antigen, underlying malignancy and primary outcome of the studies did not reveal significant differences in the rates of thromboembolism, any bleeding or major bleeding events.

CONCLUSION: The risk of both thrombosis and bleeding following CAR T-cell therapy appears to be highest in the initial months following infusion.

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