CD19 chimeric antigen receptor (CAR) T cell therapy with axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) is approved for the standard of care treatment of relapsed or refractory large B cell lymphoma (LBCL). Patients with LBCL involving the gastrointestinal (GI) tract are at risk of perforation after lymphoma-directed therapy. The outcomes of CAR T cell therapy in patients with GI involvement have not been reported.
To determine the safety and efficacy of CD19 CAR T cell therapy among patients with LBCL involvement of the GI tract.
A single-center retrospective study of 130 consecutive patients treated with standard of care or expanded access axi-cel or tisa-cel for LBCL. Of these, 24 patients had radiologic involvement of the GI tract prior to CAR T infusion. Incidence rates of severe immune effector cell-mediated toxicities and clinical outcomes were compared between the GI and non-GI involvement groups.
Of 24 patients with GI tract involvement, perforation occurred in 3 patients. One patient had a contained gastric perforation after leukapheresis while receiving bridging radiation therapy to the stomach. This patient was eventually able to proceed with lymphodepletion and product infusion. In the other 2 patients GI tract perforation occurred after CAR T infusion at day +13 and day +35. All 3 patients subsequently died while experiencing lymphoma progression. Upper GI bleeding occurred in 1 additional patient in the context of progressive disease 6 months after product infusion. Comparing the 24 patients with GI tract involvement to the 106 patients without GI tract involvement, the incidence of severe CRS and ICANS, length of hospitalization, use of anti-IL6, and steroids were similar. No significant differences between groups were found in the best overall response rate, progression-free survival, or overall survival.
Outcomes of patients with GI tract involvement prior to CAR T cell therapy are similar to those without GI involvement, and durable remissions can be observed. However, patients with pre-existing GI tract involvement are at risk of perforation from disease progression before or after CAR T cell infusion.

Copyright © 2021. Published by Elsevier Inc.

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