Demographics and preinfusion variables in patients by occurrence of PSN
| Variable . | No PSN (n = 122) . | PSN (n = 22) . | Overall (N = 144) . | P value . |
|---|---|---|---|---|
| Sex | .11 | |||
| Female | 44 (78.6%) | 12 (21.4%) | 56 (38.9%) | |
| Male | 78 (88.6%) | 10 (11.4%) | 88 (61.1%) | |
| Age at CAR-Ts, y | .87 | |||
| Median (IQR) | 13 (8-18) | 10.5 (6.25-18.8) | 12.5 (8-18) | |
| Race/ethnicity | .78 | |||
| Black | 3 (100%) | 0 (0%) | 3 (2.1%) | |
| Hispanic | 43 (84.3%) | 8 (15.7%) | 51 (35.4%) | |
| Other | 13 (86.7%) | 2 (13.3%) | 15 (10.4%) | |
| White | 63 (84%) | 12 (16%) | 75 (52.1%) | |
| No. of relapses before CAR-Ts | .88 | |||
| Median (IQR) | 1 (1-2) | 1 (1-2) | 1 (1-2) | |
| No. of lines of therapy before CAR-Ts | .04 | |||
| Median (IQR) | 3 (2-4) | 3 (3-5) | 3 (2-4) | |
| HSCT before CAR-Ts | .26 | |||
| No | 97 (86.6%) | 15 (13.4%) | 112 (77.8%) | |
| Yes | 25 (78.1%) | 7 (21.9%) | 32 (22.2%) | |
| Months from previous HSCT to CAR-Ts | .63 | |||
| Median (IQR) | 19 (10-34.5) | 16 (6.50-18.5) | 16.5 (9-30.8) | |
| Missing | 2 (100%) | 0 (0%) | 2 (6.2%) | |
| HSCT source | .47 | |||
| Cord | 3 (100%) | 0 (0%) | 3 (9.4%) | |
| Haplo-identical | 6 (75%) | 2 (25%) | 8 (25%) | |
| Matched related | 9 (69.2%) | 4 (30.8%) | 13 (40.6%) | |
| Matched unrelated | 7 (87.5%) | 1 (12.5%) | 8 (25.0%) | |
| Intensity of most recent HSCT∗ | .51 | |||
| 1 | 22 (78.6%) | 6 (21.4%) | 28 (87.5%) | |
| 2 | 1 (100%) | 0 (0%) | 1 (3.1%) | |
| 3 | 2 (100%) | 0 (0%) | 2 (6.3%) | |
| Missing | 0 (0%) | 1 (100%) | 1 (3.1%) | |
| Bone marrow disease burden (% morphologic blasts) | <.01 | |||
| Median (IQR) | 1 (0-9) | 36.0 (8-84) | 1.80 (0-15) | |
| Missing | 4 (80%) | 1 (20%) | 5 (3.5%) | |
| High disease burden† | <.01 | |||
| No | 73 (96.1%) | 3 (3.9%) | 76 (52.8%) | |
| Yes | 47 (71.2%) | 19 (28.8%) | 66 (45.8%) | |
| Missing | 2 (100%) | 0 (0%) | 2 (1.4%) | |
| CAR-T dose infused (×106/kg) | .24 | |||
| Median (IQR) | 1.70 (1.30-2.4) | 1.77 (1.52-2.5) | 1.70 (1.31-2.4) | |
| Missing | 1 (100%) | 0 (0%) | 1 (0.7%) | |
| Chemotherapy regimen | .02 | |||
| Fludarabine (30 mg/m2 × 4 days) and cyclophosphamide (500 mg/m2 × 2 days) | 120 (86.3%) | 19 (13.7%) | 139 (96.5%) | |
| Other | 2 (40.0%) | 3 (60.0%) | 5 (3.5%) | |
| Ferritin (ng/mL) | .007 | |||
| Median (IQR) | 998 (572-2120) | 2630 (1210-5500) | 1230 (578-2630) | |
| Missing | 12 (80%) | 3 (20%) | 15 (10.4%) | |
| CRP (mg/dL) | <.01 | |||
| Median (IQR) | 0.49 (0.3-1.4) | 4.56 (0.93-7.3) | 0.50 (0.3-1.79) | |
| Missing | 17 (77.3%) | 5 (22.7%) | 22 (15.3%) | |
| Platelet (×109/L) | <.01 | |||
| Median (IQR) | 134 (84-209) | 24.5 (21-107) | 122 (55.8-206) | |
| ANC (cells per mm3) | <.01 | |||
| Median (IQR) | 590 (250-1090) | 30 (0-195) | 500 (180-1040) | |
| Absolute leukocyte count (cells per mm3) | .20 | |||
| Median (IQR) | 70.0 (30-143) | 40.0 (2.5-90) | 60.0 (20-125) | |
| LDH (U/L) | .01 | |||
| Median (IQR) | 214 (176-309) | 283 (194-504) | 217 (178-319) | |
| Missing | 11 (84.6%) | 2 (15.4%) | 13 (9%) | |
| Creatinine (mg/dL) | .64 | |||
| Median (IQR) | 0.47 (0.34-0.64) | 0.6 (0.31-0.68) | 0.49 (0.34-0.64) |
| Variable . | No PSN (n = 122) . | PSN (n = 22) . | Overall (N = 144) . | P value . |
|---|---|---|---|---|
| Sex | .11 | |||
| Female | 44 (78.6%) | 12 (21.4%) | 56 (38.9%) | |
| Male | 78 (88.6%) | 10 (11.4%) | 88 (61.1%) | |
| Age at CAR-Ts, y | .87 | |||
| Median (IQR) | 13 (8-18) | 10.5 (6.25-18.8) | 12.5 (8-18) | |
| Race/ethnicity | .78 | |||
| Black | 3 (100%) | 0 (0%) | 3 (2.1%) | |
| Hispanic | 43 (84.3%) | 8 (15.7%) | 51 (35.4%) | |
| Other | 13 (86.7%) | 2 (13.3%) | 15 (10.4%) | |
| White | 63 (84%) | 12 (16%) | 75 (52.1%) | |
| No. of relapses before CAR-Ts | .88 | |||
| Median (IQR) | 1 (1-2) | 1 (1-2) | 1 (1-2) | |
| No. of lines of therapy before CAR-Ts | .04 | |||
| Median (IQR) | 3 (2-4) | 3 (3-5) | 3 (2-4) | |
| HSCT before CAR-Ts | .26 | |||
| No | 97 (86.6%) | 15 (13.4%) | 112 (77.8%) | |
| Yes | 25 (78.1%) | 7 (21.9%) | 32 (22.2%) | |
| Months from previous HSCT to CAR-Ts | .63 | |||
| Median (IQR) | 19 (10-34.5) | 16 (6.50-18.5) | 16.5 (9-30.8) | |
| Missing | 2 (100%) | 0 (0%) | 2 (6.2%) | |
| HSCT source | .47 | |||
| Cord | 3 (100%) | 0 (0%) | 3 (9.4%) | |
| Haplo-identical | 6 (75%) | 2 (25%) | 8 (25%) | |
| Matched related | 9 (69.2%) | 4 (30.8%) | 13 (40.6%) | |
| Matched unrelated | 7 (87.5%) | 1 (12.5%) | 8 (25.0%) | |
| Intensity of most recent HSCT∗ | .51 | |||
| 1 | 22 (78.6%) | 6 (21.4%) | 28 (87.5%) | |
| 2 | 1 (100%) | 0 (0%) | 1 (3.1%) | |
| 3 | 2 (100%) | 0 (0%) | 2 (6.3%) | |
| Missing | 0 (0%) | 1 (100%) | 1 (3.1%) | |
| Bone marrow disease burden (% morphologic blasts) | <.01 | |||
| Median (IQR) | 1 (0-9) | 36.0 (8-84) | 1.80 (0-15) | |
| Missing | 4 (80%) | 1 (20%) | 5 (3.5%) | |
| High disease burden† | <.01 | |||
| No | 73 (96.1%) | 3 (3.9%) | 76 (52.8%) | |
| Yes | 47 (71.2%) | 19 (28.8%) | 66 (45.8%) | |
| Missing | 2 (100%) | 0 (0%) | 2 (1.4%) | |
| CAR-T dose infused (×106/kg) | .24 | |||
| Median (IQR) | 1.70 (1.30-2.4) | 1.77 (1.52-2.5) | 1.70 (1.31-2.4) | |
| Missing | 1 (100%) | 0 (0%) | 1 (0.7%) | |
| Chemotherapy regimen | .02 | |||
| Fludarabine (30 mg/m2 × 4 days) and cyclophosphamide (500 mg/m2 × 2 days) | 120 (86.3%) | 19 (13.7%) | 139 (96.5%) | |
| Other | 2 (40.0%) | 3 (60.0%) | 5 (3.5%) | |
| Ferritin (ng/mL) | .007 | |||
| Median (IQR) | 998 (572-2120) | 2630 (1210-5500) | 1230 (578-2630) | |
| Missing | 12 (80%) | 3 (20%) | 15 (10.4%) | |
| CRP (mg/dL) | <.01 | |||
| Median (IQR) | 0.49 (0.3-1.4) | 4.56 (0.93-7.3) | 0.50 (0.3-1.79) | |
| Missing | 17 (77.3%) | 5 (22.7%) | 22 (15.3%) | |
| Platelet (×109/L) | <.01 | |||
| Median (IQR) | 134 (84-209) | 24.5 (21-107) | 122 (55.8-206) | |
| ANC (cells per mm3) | <.01 | |||
| Median (IQR) | 590 (250-1090) | 30 (0-195) | 500 (180-1040) | |
| Absolute leukocyte count (cells per mm3) | .20 | |||
| Median (IQR) | 70.0 (30-143) | 40.0 (2.5-90) | 60.0 (20-125) | |
| LDH (U/L) | .01 | |||
| Median (IQR) | 214 (176-309) | 283 (194-504) | 217 (178-319) | |
| Missing | 11 (84.6%) | 2 (15.4%) | 13 (9%) | |
| Creatinine (mg/dL) | .64 | |||
| Median (IQR) | 0.47 (0.34-0.64) | 0.6 (0.31-0.68) | 0.49 (0.34-0.64) |
CNS, central nervous system; IQR, interquartile range; LDH, lactate dehydrogenase.
Intensity of HSCT defined as: (1) myeloablative HSCT with radiation, (2) myeloablative SCT with chemotherapy, and (3) nonmyeloablative.
High disease burden defined as: >5% bone marrow blasts, having CNS3 disease, having peripheral blasts, odds ratio having non-CNS extramedullary disease.