Toxicity
The most common adverse events of any Grade were cytokine release syndrome (CRS) (58%), anaemia (48%), pyrexia (35%), reduced neutrophil count (34%), decreased platelet count (33%), decreased white cell count (33%) and diarrhoea (32%). Grade 3 or 4 adverse events of interest within the first 8 weeks of infusion included CRS (22%), cytopenias not resolved by day 28(32%), infections (20%), neurologic events (12%) and febrile neutropenia (15%).r
Median time from infusion to onset of CRS was 3 days, and the median duration was 7 days (range, 2 to 30). 14% of patients received tocilizumab (TCZ), and 10% received both TCZ and glucocorticoids. Additionally, patients with CRS received oxygen supplementation (24%), endotracheal intubation (7%), high-dose vasopressors (6%) and dialysis (5%). 24% were admitted to ICU.r
Neurologic events of any Grade occurred in 21% of patients within 8 weeks after infusion. Median time to onset was 6 days (range, 1 to 17), and the median duration was 14 days. 12% of patients had Grade 3 or 4 neurological events. Neurological events were managed in accordance with local guidelines. There was no fatal cerebral oedema.r
Three patients died within 30 days after infusion. All deaths were due to lymphoma progression. No deaths after infusion were attributed to tisagenlecleucel by the investigators.r
Table 1: Adverse effects associated with tisagenlecleucelr
© NEJM 2019