Table 2.
Univariable analysis | Multivariable analysis* | |||||||
---|---|---|---|---|---|---|---|---|
Characteristic | N | HR1 | 95% CI1 | p-value | N | HR1 | 95% CI1 | p-value |
Age at infusion (binary) | 305 | 0.36 | ||||||
≤ 65 | — | — | ||||||
> 65 | 0.88 | 0.67, 1.15 | ||||||
LBCL type | 302 | 0.061 | ||||||
De novo | — | — | ||||||
Transformed low-grade | 0.77 | 0.58, 1.02 | ||||||
Cell of origin | 264 | 0.052 | 255 | 0.026 | ||||
Germinal Center B cells | — | — | — | — | ||||
non- Germinal Center B cells | 1.33 | 1.00, 1.77 | 1.43 | 1.04, 1.97 | ||||
Double/triple hit 2 | 213 | 0.62 | ||||||
No | — | — | ||||||
Yes | 1.12 | 0.72, 1.75 | ||||||
Number of prior lines of therapy | 305 | 0.36 | ||||||
2 lines | — | — | ||||||
3 lines | 1.19 | 0.84, 1.68 | 1.19 | |||||
4–5 lines | 0.88 | 0.62, 1.25 | 0.88 | |||||
6+ lines | 1.15 | 0.71, 1.85 | 1.15 | |||||
Prior autologous transplantation | 305 | 0.14 | ||||||
No | — | — | ||||||
Yes | 0.79 | 0.58, 1.09 | ||||||
Prior allogeneic transplantation | 305 | 0.77 | ||||||
No | — | — | ||||||
Yes | 1.10 | 0.60, 2.01 | ||||||
Primary refractory disease up to apheresis | 304 | <0.001 | 255 | 0.003 | ||||
No | — | — | — | — | ||||
Yes | 1.70 | 1.30, 2.22 | 1.64 | 1.18, 2.28 | ||||
Bulky disease at apheresis | 305 | 0.003 | 255 | 0.007 | ||||
No | — | — | — | — | ||||
Yes | 1.81 | 1.26, 2.59 | 1.82 | 1.18, 2.82 | ||||
Stage at apheresis | 303 | 0.035 | 255 | 0.31 | ||||
≤ II | — | — | — | — | ||||
III-IV | 1.38 | 1.01, 1.88 | 1.21 | 0.84, 1.73 | ||||
Bridging therapy | 305 | 0.50 | ||||||
No | — | — | ||||||
Yes | 1.10 | 0.84, 1.44 | ||||||
Pre-CAR-T LDH | 298 | <0.001 | 255 | <0.001 | ||||
Normal range | — | — | — | — | ||||
> ULN | 2.03 | 1.53, 2.69 | 1.89 | 1.37, 2.60 | ||||
Disease status at the time of CAR-T infusion | 302 | <0.001 | 255 | 0.012 | ||||
Complete response | — | — | — | — | ||||
Partial response | 2.46 | 0.88, 6.90 | 1.90 | 0.44, 8.18 | ||||
Stable/Progressive disease | 3.72 | 1.38, 10.0 | 3.32 | 0.80, 13.8 | ||||
CART product | 305 | 0.002 | 255 | 0.005 | ||||
Axicabtagene ciloleucel | — | — | — | — | ||||
Lisocabtagene maraleucel | 1.15 | 0.71, 1.88 | 1.32 | 0.79, 2.23 | ||||
POC-CAR-T | 1.88 | 1.33, 2.65 | 1.64 | 0.98, 2.74 | ||||
Tisagenlecleucel | 1.56 | 1.11, 2.20 | 2.03 | 1.37, 3.00 |
Multivariable cox regression analysis were stratified by center
HR = Hazard Ratio, CI = Confidence Interval
Double/triple hit is defined by two or three recurrent chromosome translocations; MYC/8q24 loci in combination with the t (14; 18) (q32; q21) bcl-2 gene or/and BCL6/3q27 chromosomal translocation.
Abbreviations: Large B cell lymphoma (LBCL), Lactate dehydrogenase (LDH), Upper Limit of Normal (ULN), Point-of-Care CD19-CAR-T cell (POC).