Table 5.
Treatment-related toxicity and survival outcomes among patients who received CAR T-cell therapy
| Characteristic | BT | P | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All patients (n = 124) | No BT (n = 62) | ||||||||||||
| All (n = 62) | ST (n = 45) | RT (n = 11) | CMT (n = 6) | No BT vs BT | No BT vs ST | No BT vs RT | No BT vs CMT | ST vs RT | ST vs CMT | RT vs CMT | |||
| Outcome | |||||||||||||
| Overall response | 96 (77) | 51 (82) | 45 (73) | 30 (67) | 11 (100) | 4 (67) | .23 | .08 | .13 | .38 | .03 | 1.0 | .05 |
| CR | 60 (48) | 30 (48) | 30 (48) | 17 (38) | 9 (82) | 4 (67) | 1.0 | .30 | .04 | .38 | .01 | .18 | .50 |
| PR | 36 (29) | 21 (34) | 15 (24) | 13 (29) | 2 (18) | 0 (0) | |||||||
| SD/PD | 22 (18) | 9 (15) | 13 (21) | 11 (24) | 0 (0) | 2 (33) | |||||||
| Not assessed | 6 (5) | 2 (3) | 4 (7) | 4 (9) | 0 (0) | 0 (0) | |||||||
| PFS, mo | .06 | .01 | .52 | .36 | .05 | .78 | .17 | ||||||
| Median | 6.2 | 9.2 | 5.1 | 4.7 | 8.9 | 2.5 | |||||||
| 95% CI | 4.1-8.3 | 3.4-15.0 | 3.8-6.4 | 3.0-6.3 | 8.2-9.5 | 0.0-8.3 | |||||||
| OS, mo | .22 | .17 | .40 | .03 | .15 | .30 | .02 | ||||||
| Median | 21.9 | NR | 21.9 | 21.9 | NR | 3.9 | |||||||
| 95% CI | NE | NE | 0-47.6 | 0-8.7 | |||||||||
| Toxicity | |||||||||||||
| CRS grade ≥3 | 11 (9) | 6 (10) | 5 (8) | 4 (9) | 0 (0) | 1 (17) | 1.00 | 1.00 | .58 | .49 | .58 | .48 | .35 |
| CRES/ICANS grade ≥3 | 49 (40) | 21 (34) | 28 (45) | 22 (49) | 3 (27) | 3 (50) | .27 | .16 | 1.00 | .66 | .31 | 1.00 | .60 |
| Tocilizumab administration | 85 (69) | 41 (66) | 44 (71) | 31 (69) | 8 (73) | 5 (83) | .70 | .84 | 1.00 | .66 | 1.00 | .66 | 1.00 |
| Steroid administration | 73 (59) | 34 (55) | 39 (63) | 27 (60) | 7 (64) | 5 (83) | .47 | .69 | .75 | .23 | 1.00 | .39 | .60 |
| ICU admission | 46 (37) | 19 (31) | 27 (44) | 20 (44) | 3 (27) | 4 (67) | .19 | .16 | 1.00 | .17 | .50 | .40 | .16 |
| Death resulting from toxicity | 11 (9) | 4 (6) | 7 (11) | 7 (16) | 0 (0) | 0 (0) | .34 | .13 | .39 | .52 | .16 | .30 | 1.0 |
Values are n (%) unless otherwise noted. P values in bold indicate statistical significance (≤.05).
CRES, CAR T-cell–related encephalopathy syndrome; ICU, intensive care unit; NR, not reached; PD, progressive disease; SD, stable disease.