Multivariable Cox proportional hazards model for severe (grade ≥3) infection
| Cox proportional-hazards model for grade ≥3 infection (D0-90) | Adjusted HR (95% CI) | P value |
| Pre-CAR-T variables | ||
| Age (≥65 yo) | 1.22 (0.73 to 2.03) | 0.45 |
| Disease entity (transformed lymphoma) | 1.43 (0.77 to 2.66) | 0.26 |
| Prior ASCT | 0.86 (0.47 to 1.59) | 0.63 |
| ECOG performance status (≥2) | 1.10 (0.74 to 1.66) | 0.64 |
| LDH >ULN | 0.95 (0.54 to 1.68) | 0.86 |
| Absolute lymphocyte count (ALC) <200 /µL | 0.92 (0.49 to 1.71) | 0.80 |
| IgG Levels <4 g/L | 0.85 (0.49 to 1.47) | 0.55 |
| CAR-HEMATOTOX (High) | 6.14 (2.93 to 12.87) | <0.0001 |
| Post-CART variables | ||
| CAR T-cell product (Tisa-cel) | 1.31 (0.74 to 2.29) | 0.35 |
| ICU admission | 1.22 (0.57 to 2.59) | 0.61 |
| CRS grade (ASTCT≥2°) | 1.65 (0.87 to 3.16) | 0.13 |
| ICANS grade (ASTCT≥2°) | 1.10 (0.50 to 2.38) | 0.82 |
| Tocilizumab use | 0.93 (0.46 to 1.86) | 0.83 |
| Corticosteroid administration ≥9 days (≥10 mg Dexamethasone equivalent between D0-21) | 2.08 (1.01 to 4.29) | 0.047 |
| G-CSF use | 0.82 (0.44 to 1.54) | 0.54 |
| Antibacterial prophylaxis use | 0.44 (0.26 to 0.77) | 0.004 |
| Severe neutropenia ≥14 days (ANC<500/µL between day 0 and 60) | 3.13 (1.74 to 5.62) | <0.0001 |
Abbreviations: ANC, Absolute Neutrophil Count; G-CSF, Granulocyte-colony stimulating factor; ASTCT, American Society for Transplantation and Cellular Therapy; ECOG, Eastern Cooperative Oncology Group; ULN, Upper Limit of Normal; ICU, Intensive Care Unit.
CAR-T, chimeric antigen receptor T-cells; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; LDH, lactate dehydrogenase.