Baseline characteristics
| Baseline characteristics . | Total, N = 262 . | ITT, n = 207 . | HD-MTX, n = 34 . | Both, n = 21 . | P value . |
|---|---|---|---|---|---|
| Diagnosis, n (%) | .38 | ||||
| DLBCL NOS | 229 (87.4) | 183 (88.4) | 30 (88.2) | 16 (76.2) | |
| DHL/THL | 12 (4.6) | 10 (4.8) | 1 (2.9) | 1 (4.8) | |
| HGBL NOS | 21 (8) | 14 (6.8) | 3 (8.8) | 4 (19) | |
| Sex, n (%) | .82 | ||||
| Male | 141 (53.8) | 97 (46.9) | 14 (41.2) | 10 (47.6) | |
| Female | 121 (46.2) | 110 (53.1) | 20 (58.8) | 11 (52.4) | |
| Age (median, IQR) | .14 | ||||
| 63 (53-71) | 64 (53-72) | 58 (53-65) | 60 (50-64) | ||
| HIV-positive, n (%) | .96 | ||||
| 21 (8) | 17 (8.2) | 3 (8.8) | 1 (4.8) | ||
| EN sites, n (%) | .01 | ||||
| 0 | 40 (15.3) | 33 (15.9) | 7 (20.6) | 0 (0) | |
| 1 | 113 (43.1) | 96 (46.4) | 7 (20.6) | 10 (47.6) | |
| ≥2 | 109 (41.6) | 78 (37.7) | 20 (58.8) | 11 (52.4) | |
| IPI, n (%) | .69 | ||||
| 0-1 | 48 (18.4) | 36 (17.5) | 9 (26.5) | 3 (14.3) | |
| 2 | 53 (20.3) | 42 (20.3) | 4 (11.8) | 7 (33.3) | |
| 3 | 71 (27.2) | 57 (27.5) | 9 (26.5) | 5 (23.8) | |
| ≥4 | 86 (33) | 68 (33) | 12 (35.3) | 6 (28.6) | |
| NE | 3 (1.1) | 3 (1.5) | 0 (0) | (0) | |
| CNS IPI, n (%) | .49 | ||||
| 0-1 | 53 (20.3) | 39 (18.9) | 11 (32.4) | 3 (14.3) | |
| 2-3 | 122 (46.7) | 100 (48.5) | 13 (38.2) | 9 (42.9) | |
| ≥4 | 83 (31.8) | 64 (30.9) | 10 (29.4) | 9 (42.9) | |
| NE | 3 (1.1) | 3 (1.5) | 0 (0) | 0 (0) | |
| COO, n (%) | .71 | ||||
| No GC | 102 (38.9) | 81 (39.1) | 15 (44.1) | 6 (28.6) | |
| GC | 131 (50) | 102 (49.3) | 17 (50) | 12 (57.1) | |
| NE | 29 (11.1) | 24 (11.6) | 2 (5.9) | 3 (14.3) | |
| DEL, n (%) | .12 | ||||
| Yes | 78 (29.8) | 61 (29.5) | 9 (26.5) | 8 (38.1) | |
| No | 115 (43.9) | 85 (41.1) | 18 (52.9) | 12 (57.1) | |
| NE | 69 (26.3) | 61 (29.5) | 7 (20.6) | 1 (4.8) | |
| DHL, n (%) | .29 | ||||
| Yes | 8 (3.1) | 7 (3.4) | 1 (2.9) | 0 (0) | |
| No | 57 (21.8) | 40 (19.3) | 9 (26.5) | 8 (38.1) | |
| NE | 197 (75.2) | 160 (77.3) | 24 (70.6) | 13 (61.9) | |
| CNS evaluation, n (%) | .1 | ||||
| MRI | 17 (6.5) | 14 (6.8) | 2 (5.9) | 1 (4.8) | |
| CSF cytology | 137 (52.3) | 111 (53.6) | 16 (47.1) | 10 (47.6) | |
| MRI + CSF cytology | 81 (30.9) | 63 (30.4) | 8 (23.5) | 10 (47.6) | |
| None | 27 (10.3) | 19 (9.2) | 8 (23.5) | 0 | |
| First-line treatment, n (%) | .71 | ||||
| R-CHOP | 192 (73.3) | 147 (71) | 28 (82.4) | 17 (81) | |
| DA-EPOCH-R | 62 (23.7) | 42 (52.1) | 6 (17.6) | 4 (19) | |
| R-HyperCVAD | 3 (1.1) | 3 (1.4) | 0 (0) | 0 (0) | |
| Other | 5 (1.9) | 5 (2.4) | 0 (0) | (0) |
| Baseline characteristics . | Total, N = 262 . | ITT, n = 207 . | HD-MTX, n = 34 . | Both, n = 21 . | P value . |
|---|---|---|---|---|---|
| Diagnosis, n (%) | .38 | ||||
| DLBCL NOS | 229 (87.4) | 183 (88.4) | 30 (88.2) | 16 (76.2) | |
| DHL/THL | 12 (4.6) | 10 (4.8) | 1 (2.9) | 1 (4.8) | |
| HGBL NOS | 21 (8) | 14 (6.8) | 3 (8.8) | 4 (19) | |
| Sex, n (%) | .82 | ||||
| Male | 141 (53.8) | 97 (46.9) | 14 (41.2) | 10 (47.6) | |
| Female | 121 (46.2) | 110 (53.1) | 20 (58.8) | 11 (52.4) | |
| Age (median, IQR) | .14 | ||||
| 63 (53-71) | 64 (53-72) | 58 (53-65) | 60 (50-64) | ||
| HIV-positive, n (%) | .96 | ||||
| 21 (8) | 17 (8.2) | 3 (8.8) | 1 (4.8) | ||
| EN sites, n (%) | .01 | ||||
| 0 | 40 (15.3) | 33 (15.9) | 7 (20.6) | 0 (0) | |
| 1 | 113 (43.1) | 96 (46.4) | 7 (20.6) | 10 (47.6) | |
| ≥2 | 109 (41.6) | 78 (37.7) | 20 (58.8) | 11 (52.4) | |
| IPI, n (%) | .69 | ||||
| 0-1 | 48 (18.4) | 36 (17.5) | 9 (26.5) | 3 (14.3) | |
| 2 | 53 (20.3) | 42 (20.3) | 4 (11.8) | 7 (33.3) | |
| 3 | 71 (27.2) | 57 (27.5) | 9 (26.5) | 5 (23.8) | |
| ≥4 | 86 (33) | 68 (33) | 12 (35.3) | 6 (28.6) | |
| NE | 3 (1.1) | 3 (1.5) | 0 (0) | (0) | |
| CNS IPI, n (%) | .49 | ||||
| 0-1 | 53 (20.3) | 39 (18.9) | 11 (32.4) | 3 (14.3) | |
| 2-3 | 122 (46.7) | 100 (48.5) | 13 (38.2) | 9 (42.9) | |
| ≥4 | 83 (31.8) | 64 (30.9) | 10 (29.4) | 9 (42.9) | |
| NE | 3 (1.1) | 3 (1.5) | 0 (0) | 0 (0) | |
| COO, n (%) | .71 | ||||
| No GC | 102 (38.9) | 81 (39.1) | 15 (44.1) | 6 (28.6) | |
| GC | 131 (50) | 102 (49.3) | 17 (50) | 12 (57.1) | |
| NE | 29 (11.1) | 24 (11.6) | 2 (5.9) | 3 (14.3) | |
| DEL, n (%) | .12 | ||||
| Yes | 78 (29.8) | 61 (29.5) | 9 (26.5) | 8 (38.1) | |
| No | 115 (43.9) | 85 (41.1) | 18 (52.9) | 12 (57.1) | |
| NE | 69 (26.3) | 61 (29.5) | 7 (20.6) | 1 (4.8) | |
| DHL, n (%) | .29 | ||||
| Yes | 8 (3.1) | 7 (3.4) | 1 (2.9) | 0 (0) | |
| No | 57 (21.8) | 40 (19.3) | 9 (26.5) | 8 (38.1) | |
| NE | 197 (75.2) | 160 (77.3) | 24 (70.6) | 13 (61.9) | |
| CNS evaluation, n (%) | .1 | ||||
| MRI | 17 (6.5) | 14 (6.8) | 2 (5.9) | 1 (4.8) | |
| CSF cytology | 137 (52.3) | 111 (53.6) | 16 (47.1) | 10 (47.6) | |
| MRI + CSF cytology | 81 (30.9) | 63 (30.4) | 8 (23.5) | 10 (47.6) | |
| None | 27 (10.3) | 19 (9.2) | 8 (23.5) | 0 | |
| First-line treatment, n (%) | .71 | ||||
| R-CHOP | 192 (73.3) | 147 (71) | 28 (82.4) | 17 (81) | |
| DA-EPOCH-R | 62 (23.7) | 42 (52.1) | 6 (17.6) | 4 (19) | |
| R-HyperCVAD | 3 (1.1) | 3 (1.4) | 0 (0) | 0 (0) | |
| Other | 5 (1.9) | 5 (2.4) | 0 (0) | (0) |
GC, germinal center; COO, cell of origin by Hans algorithms; CSF, cerebrospinal fluid; DEL, double expressor; DHL/THL, double-hit/triple-hit lymphoma; EN, extranodal; HGBL, high-grade B-cell lymphoma; MRI, magnetic resonance imaging; NE, not evaluated; NOS, not otherwise specified; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; DA-EPOCH-R, dose-intensified regimen dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; R-HyperCVAD, rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone.