Cancer Risk in Kidney Transplant Recipients on Belatacept Versus Calcineurin Inhibitors: A Systematic Review and Meta-Analysis.

BACKGROUND: Belatacept has been increasingly used as a maintenance immunosuppression in kidney transplant recipients since its approval in 2011, due to favorable renal and cardiovascular profiles compared with calcineurin inhibitors (CNIs). However, the long-term risk of cancers associated with beletacept, particularly skin cancer, remains incompletely characterized. METHODS: We conducted a systematic review and meta-analysis of clinical studies comparing cancer risk in kidney transplant recipients receiving belatacept-based regimens versus CNI-based regimens. Thirteen studies were included, comprising 3,070 patients from 10 randomized controlled trials and 3 observational cohort studies. Pooled risk estimates were calculated for skin cancers and other cancers. Subgroup analyses were performed to compare patients converted from CNIs to belatacept to those receiving de novo belatacept. RESULTS: Across all included studies, there was no statistically significant difference in the risk of skin cancer (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.67-1.52) or all cancers (OR, 1.14; 95% CI, 0.69-1.88) between belatacept-based and CNI-based regimens. However, in subgroup analyses, patients converted from CNIs to belatacept demonstrated a trend toward increased risk of both skin cancers (OR, 1.82; 95% CI, 0.43-7.63) and all cancers (OR, 1.83; 95% CI, 0.99-3.39) compared with those receiving de novo belatacept (skin cancer: OR 0.85; 95% CI, 0.68-1.06, all cancers: OR, 0.92; 95% CI, 0.41-2.09). CONCLUSIONS: Overall, belatacept-based immunosuppression was not associated with a significantly increased risk of skin or other cancers compared with CNI-based regimens. Larger, adequately powered studies with cancer outcomes as primary endpoints are needed to better define cancer risk associated with belatacept conversion in kidney transplant recipients.