Characteristics of patients indicated for CART (LC and VC)
| Patient feature . | Categories or statistics . | LC: 577 patients, n (%) . | VC: 218 patients, n (%) . | P value∗ . |
|---|---|---|---|---|
| Number of centers | Count | 9 | 1 | N/A |
| IPI risk category† | Low | 174 (30.2) | N/A | |
| Low-intermed | 187 (32.4) | |||
| High-intermed | 151 (26.2) | |||
| High | 65 (11.3) | |||
| Elevated serum LDH (>ULN)‡ | No | 274 (47.5) | 81 (37.2) | .010 |
| Yes | 303 (52.5) | 137 (62.8) | ||
| Concurrent indolent lymphoma (any type of transformed disease) | No | 394 (68.3) | 170 (78.0) | .102 |
| Yes | 154 (26.7) | 48 (22.0) | ||
| NA | 29 (5.0) | 0 | ||
| Transformed follicular lymphoma | No | 428 (74.2) | 178 (81.7) | .373 |
| Yes | 118 (20.5) | 40 (18.3) | ||
| NA | 31 (5.4) | 0 | ||
| Richter transformation | No | 528 (91.5) | 215 (98.6) | .219 |
| Yes | 18 (3.1) | 3 (1.4) | ||
| NA | 31 (5.4) | 0 | ||
| Dx to T-cell collection (y) | median (IQR) | 1 (1-3) | N/A | |
| range | 0 -37 | |||
| NA | n=48 | |||
| Age at T-cell collection | median (IQR): | 63 (55-70) | 60.5 (51-68) | .049 |
| range: | 19-90 | 18-89 | ||
| ECOG at T-cell collection | 0 | 195 (33.8) | 55 (25.2) | <.001 |
| 1 | 325 (56.3) | 107 (49.1) | ||
| 2/3/4 | 56 (9.7) | 56 (25.7) | ||
| NA | 1 (0.2) | 0 | ||
| Number of previous treatments | median (IQR): | 3 (2-4) | 3 (2-4) | .002 |
| range: | 1-11 | 1-11 | ||
| Previous transplant (autologous or allogeneic) | No | 432 (74.9) | 173 (79.4) | .193 |
| Yes | 145 (25.1) | 45 (20.6) | ||
| Number of medications (excluding PRN and vit.) | median (IQR) | 5 (3-7) | N/A | |
| range | 0-17 | |||
| Complex karyotype | No | 427 (74.0) | N/A | |
| Yes | 42 (7.3) | |||
| NA | 108 (18.7) | |||
| Double hit (MYC translocation with BCL2 or BCL6 translocation) | No | 431 (74.7) | 91 (41.7) | .508 |
| Yes | 95 (16.5) | 24 (11.0) | ||
| NA | 51 (8.8) | 103 (47.2) | ||
| Molecular subtype | GCB | 312 (54.1) | 87 (39.9) | .924 |
| non-GCB | 218 (37.8) | 59 (27.1) | ||
| NA | 47 (8.1) | 72 (33.0) | ||
| Respiratory (CIRS) | 0/1/2 (≤moderate) | 553 (95.8) | 211 (96.8) | .682 |
| 3/4 (severe) | 24 (4.2) | 7 (3.2) | ||
| Upper GI (CIRS) | 0/1/2 (≤moderate) | 561 (97.2) | 217 (99.5) | .052 |
| 3/4 (severe) | 16 (2.8) | 1 (0.5) | ||
| Hepatic (CIRS) | 0/1/2 (≤moderate) | 568 (98.4) | 207 (95.0) | .009 |
| 3/4 (severe) | 9 (1.6) | 11 (5.0) | ||
| Renal (CIRS) | 0/1/2 (≤moderate) | 566 (98.1) | 197 (90.4) | <.001 |
| 3/4 (severe) | 11 (1.9) | 21 (9.6) | ||
| Severe4 | No | 523 (90.6) | 183 (83.9) | .011 |
| Yes | 54 (9.4) | 35 (16.1) | ||
| Bridging therapy (to CART infusion) | No | 279 (48.4) | N/A | |
| Yes | 298 (51.6) | |||
| Bendamustine included in bridging therapy | No | 515 (89.3) | N/A | |
| Yes | 62 (10.7) | |||
| Nonbendamustine chemotherapy bridging | No | 465 (80.6) | N/A | |
| Yes | 112 (19.4) | |||
| Steroids as bridging therapy | No | 504 (87.3) | N/A | |
| Yes | 73 (12.7) | |||
| Radiation as bridging therapy | No | 543 (94.1) | N/A | |
| Yes | 34 (5.9) | |||
| Other bridging therapy | No | 365 (63.3) | N/A | |
| Yes | 212 (36.7) | |||
| CART product § | Axi-cel (Yescarta) | 393 (71.5) | 213 (97.7) | <.001 |
| Tisa-cel (Kymriah) | 120 (21.8) | 5 (2.3) | ||
| Liso-cel (Breyanzi) | 37 (6.7) | 0 | ||
| NA | 27 (4.7) | 0 | ||
| Response to CART § | CR | 290 (52.7) | 59 (27.1) | .417 |
| PR | 130 (23.6) | 36 (16.5) | ||
| SD | 13 (2.4) | 4 (1.8) | ||
| PD | 93 (16.9) | 17 (7.8) | ||
| NA | 24 (4.4) | 102 (46.8) | ||
| CRS grade § | 0 | 115 (19.9) | 17 (7.8) | <.001 |
| 1 | 227 (39.3) | 91 (41.7) | ||
| 2 | 166 (28.8) | 73 (33.5) | ||
| 3 | 27 (4.7) | 24 (11.0) | ||
| 4 | 11 (1.9) | 13 (6.0) | ||
| NA | 31 (5.4) | 0 | ||
| ICANS grade § | 0 | 289 (50.1) | 83 (38.1) | <.001 |
| 1 | 76 (13.2) | 29 (13.3) | ||
| 2 | 64 (11.1) | 22 (10.1) | ||
| 3 | 86 (14.9) | 51 (23.4) | ||
| 4/5 | 23 (4.0) | 33 (15.1) | ||
| NA | 39 (6.8) | 0 |
| Patient feature . | Categories or statistics . | LC: 577 patients, n (%) . | VC: 218 patients, n (%) . | P value∗ . |
|---|---|---|---|---|
| Number of centers | Count | 9 | 1 | N/A |
| IPI risk category† | Low | 174 (30.2) | N/A | |
| Low-intermed | 187 (32.4) | |||
| High-intermed | 151 (26.2) | |||
| High | 65 (11.3) | |||
| Elevated serum LDH (>ULN)‡ | No | 274 (47.5) | 81 (37.2) | .010 |
| Yes | 303 (52.5) | 137 (62.8) | ||
| Concurrent indolent lymphoma (any type of transformed disease) | No | 394 (68.3) | 170 (78.0) | .102 |
| Yes | 154 (26.7) | 48 (22.0) | ||
| NA | 29 (5.0) | 0 | ||
| Transformed follicular lymphoma | No | 428 (74.2) | 178 (81.7) | .373 |
| Yes | 118 (20.5) | 40 (18.3) | ||
| NA | 31 (5.4) | 0 | ||
| Richter transformation | No | 528 (91.5) | 215 (98.6) | .219 |
| Yes | 18 (3.1) | 3 (1.4) | ||
| NA | 31 (5.4) | 0 | ||
| Dx to T-cell collection (y) | median (IQR) | 1 (1-3) | N/A | |
| range | 0 -37 | |||
| NA | n=48 | |||
| Age at T-cell collection | median (IQR): | 63 (55-70) | 60.5 (51-68) | .049 |
| range: | 19-90 | 18-89 | ||
| ECOG at T-cell collection | 0 | 195 (33.8) | 55 (25.2) | <.001 |
| 1 | 325 (56.3) | 107 (49.1) | ||
| 2/3/4 | 56 (9.7) | 56 (25.7) | ||
| NA | 1 (0.2) | 0 | ||
| Number of previous treatments | median (IQR): | 3 (2-4) | 3 (2-4) | .002 |
| range: | 1-11 | 1-11 | ||
| Previous transplant (autologous or allogeneic) | No | 432 (74.9) | 173 (79.4) | .193 |
| Yes | 145 (25.1) | 45 (20.6) | ||
| Number of medications (excluding PRN and vit.) | median (IQR) | 5 (3-7) | N/A | |
| range | 0-17 | |||
| Complex karyotype | No | 427 (74.0) | N/A | |
| Yes | 42 (7.3) | |||
| NA | 108 (18.7) | |||
| Double hit (MYC translocation with BCL2 or BCL6 translocation) | No | 431 (74.7) | 91 (41.7) | .508 |
| Yes | 95 (16.5) | 24 (11.0) | ||
| NA | 51 (8.8) | 103 (47.2) | ||
| Molecular subtype | GCB | 312 (54.1) | 87 (39.9) | .924 |
| non-GCB | 218 (37.8) | 59 (27.1) | ||
| NA | 47 (8.1) | 72 (33.0) | ||
| Respiratory (CIRS) | 0/1/2 (≤moderate) | 553 (95.8) | 211 (96.8) | .682 |
| 3/4 (severe) | 24 (4.2) | 7 (3.2) | ||
| Upper GI (CIRS) | 0/1/2 (≤moderate) | 561 (97.2) | 217 (99.5) | .052 |
| 3/4 (severe) | 16 (2.8) | 1 (0.5) | ||
| Hepatic (CIRS) | 0/1/2 (≤moderate) | 568 (98.4) | 207 (95.0) | .009 |
| 3/4 (severe) | 9 (1.6) | 11 (5.0) | ||
| Renal (CIRS) | 0/1/2 (≤moderate) | 566 (98.1) | 197 (90.4) | <.001 |
| 3/4 (severe) | 11 (1.9) | 21 (9.6) | ||
| Severe4 | No | 523 (90.6) | 183 (83.9) | .011 |
| Yes | 54 (9.4) | 35 (16.1) | ||
| Bridging therapy (to CART infusion) | No | 279 (48.4) | N/A | |
| Yes | 298 (51.6) | |||
| Bendamustine included in bridging therapy | No | 515 (89.3) | N/A | |
| Yes | 62 (10.7) | |||
| Nonbendamustine chemotherapy bridging | No | 465 (80.6) | N/A | |
| Yes | 112 (19.4) | |||
| Steroids as bridging therapy | No | 504 (87.3) | N/A | |
| Yes | 73 (12.7) | |||
| Radiation as bridging therapy | No | 543 (94.1) | N/A | |
| Yes | 34 (5.9) | |||
| Other bridging therapy | No | 365 (63.3) | N/A | |
| Yes | 212 (36.7) | |||
| CART product § | Axi-cel (Yescarta) | 393 (71.5) | 213 (97.7) | <.001 |
| Tisa-cel (Kymriah) | 120 (21.8) | 5 (2.3) | ||
| Liso-cel (Breyanzi) | 37 (6.7) | 0 | ||
| NA | 27 (4.7) | 0 | ||
| Response to CART § | CR | 290 (52.7) | 59 (27.1) | .417 |
| PR | 130 (23.6) | 36 (16.5) | ||
| SD | 13 (2.4) | 4 (1.8) | ||
| PD | 93 (16.9) | 17 (7.8) | ||
| NA | 24 (4.4) | 102 (46.8) | ||
| CRS grade § | 0 | 115 (19.9) | 17 (7.8) | <.001 |
| 1 | 227 (39.3) | 91 (41.7) | ||
| 2 | 166 (28.8) | 73 (33.5) | ||
| 3 | 27 (4.7) | 24 (11.0) | ||
| 4 | 11 (1.9) | 13 (6.0) | ||
| NA | 31 (5.4) | 0 | ||
| ICANS grade § | 0 | 289 (50.1) | 83 (38.1) | <.001 |
| 1 | 76 (13.2) | 29 (13.3) | ||
| 2 | 64 (11.1) | 22 (10.1) | ||
| 3 | 86 (14.9) | 51 (23.4) | ||
| 4/5 | 23 (4.0) | 33 (15.1) | ||
| NA | 39 (6.8) | 0 |
Dx, diagnosis; intermed., intermediate; IQR, interquartile range; NA, not available (ie, missing data); N/A, not applicable; num., number; PD, progressive disease; PR, partial response; PRN, as needed; SD, stable disease; ULN, upper limit of normal; vit., vitamins.
P values from Wilcoxon rank-sum test for continuous features and from Fisher exact test or Pearson chi-square test for categorical features.
Determined at DLBCL diagnosis for LC; missing for VC because the IPI component risk factors were determined at CART infusion not at diagnosis.
Determined at DLBCL diagnosis for LC, and at CART infusion for VC.
Data from the 27 patients in the LC who died before receiving CART cells will automatically be missing (ie, NA) for this feature.