Key baseline characteristics, toxicity, and survival according to treatment response based on positron emission tomographies/computed tomographies on day 90 of the training cohort
| Variable . | All (n = 63) . | Rs (n = 28) . | NRs (n = 35) . | Univariate . |
|---|---|---|---|---|
| Age, median (range in y) | 64 (19-83) | 64.5 (36-83) | 60 (19-80) | .08 |
| Sex, male, n (%) | 38 (60) | 17 (61) | 21 (60) | >.99 |
| ECOG, 0 to 1, n (%) | 45 (71) | 25 (89) | 20 (57) | .01 |
| Treatment history, prior therapies, median number (range) | 3 (2-9) | 3.5 (2-5) | 2 (2-9) | .07 |
| Tumor burden | ||||
| Tumor volume, median, cm3 (range) | 56 (0-1380.5) | 33.5 (0-528.7) | 92 (0-1380.5) | .06 |
| Ann Arbor stage III-IV, n (%) | 49 (78) | 20 (71) | 29 (83) | .36 |
| LDH > ULN before lymphodepletion, n (%) | 39 (62) | 14 (50) | 25 (71) | .12 |
| CAR product | ||||
| Tisa-cel, n (%) | 40 (64) | 15 (54) | 25 (71) | .19 |
| Axi-cel, n (%) | 23 (36) | 13 (46) | 10 (29) | |
| CRS, grade ≥2, n (%) | 25 (40) | 11 (39) | 14 (40) | >.99 |
| ICANS, grade ≥2, n (%) | 12 (19) | 6 (21) | 6 (17) | .75 |
| Toxicity management, steroid administration, d 0 to 7, n (%) | 25 (40) | 12 (43) | 13 (37) | .59 |
| Survival | ||||
| PFS, median (range in mo) | 3.0 (0.6-35.3) | Not reached (1.7-35.3) | 1.3 (0.6-4.1) | <.0001 |
| OS, median (range in mo) | 12.1 (0.2-35.3) | Not reached (1.7-35.3) | 4.1 (0.2-22.2) | <.0001 |
| Variable . | All (n = 63) . | Rs (n = 28) . | NRs (n = 35) . | Univariate . |
|---|---|---|---|---|
| Age, median (range in y) | 64 (19-83) | 64.5 (36-83) | 60 (19-80) | .08 |
| Sex, male, n (%) | 38 (60) | 17 (61) | 21 (60) | >.99 |
| ECOG, 0 to 1, n (%) | 45 (71) | 25 (89) | 20 (57) | .01 |
| Treatment history, prior therapies, median number (range) | 3 (2-9) | 3.5 (2-5) | 2 (2-9) | .07 |
| Tumor burden | ||||
| Tumor volume, median, cm3 (range) | 56 (0-1380.5) | 33.5 (0-528.7) | 92 (0-1380.5) | .06 |
| Ann Arbor stage III-IV, n (%) | 49 (78) | 20 (71) | 29 (83) | .36 |
| LDH > ULN before lymphodepletion, n (%) | 39 (62) | 14 (50) | 25 (71) | .12 |
| CAR product | ||||
| Tisa-cel, n (%) | 40 (64) | 15 (54) | 25 (71) | .19 |
| Axi-cel, n (%) | 23 (36) | 13 (46) | 10 (29) | |
| CRS, grade ≥2, n (%) | 25 (40) | 11 (39) | 14 (40) | >.99 |
| ICANS, grade ≥2, n (%) | 12 (19) | 6 (21) | 6 (17) | .75 |
| Toxicity management, steroid administration, d 0 to 7, n (%) | 25 (40) | 12 (43) | 13 (37) | .59 |
| Survival | ||||
| PFS, median (range in mo) | 3.0 (0.6-35.3) | Not reached (1.7-35.3) | 1.3 (0.6-4.1) | <.0001 |
| OS, median (range in mo) | 12.1 (0.2-35.3) | Not reached (1.7-35.3) | 4.1 (0.2-22.2) | <.0001 |
ASTCT, American Society for Transplantation and Cellular Therapy, Axi-cel, axicabtagene ciloleucel; CRS, cytokine release syndrome; ICANS, immune-effector cell neurotoxicity syndrome; LDH, lactic acid dehydrogenase; mo, months; OS, overall survival; PFS, progression-free survival; tisa-cel, tisagenlecleucel; ULN, upper limit of normal.
Response was assessed by positron emission tomography/computed tomographies 3 months after infusion. Tumor volume was manually segmented at baseline for up to 6 target lesions according to Lugano criteria and is reported in cubic centimeters. ULN for LDH was 240 U/L (LMU) or 220 U/L (Erlangen). Toxicity was graded according to the ASTCT consensus grading of Lee et al, 2019.23 P values were calculated using the Mann-Whitney U test for continuous or Fisher exact test for categorical variables and log-rank testing for survival data. Values in bold indicate significant P = 0.05.