Baseline patient characteristics
| Characteristics . | Overall population (N = 258) . | ITT HD-MTX (n = 128) . | Non-ITT HD-MTX (n = 130) . | P . |
|---|---|---|---|---|
| Age, median (range), y | 62 (25-79) | 61 (25-79) | 65 (29-79) | .059 |
| Sex | ||||
| Male | 146 (56.6) | 83 (64.8) | 63 (48.5) | .011 |
| Female | 112 (43.4) | 45 (35.2) | 67 (51.5) | |
| IPI risk | ||||
| Low (0-1) | 27 (10.4) | 12 (9.4) | 15 (11.5) | .395 |
| Low-intermediate (2) | 41 (15.9) | 16 (12.5) | 25 (19.2) | |
| High-intermediate (3) | 90 (34.9) | 46 (35.9) | 44 (33.9) | |
| High (4-5) | 100 (38.8) | 54 (42.2) | 46 (35.4) | |
| IPI risk factors | ||||
| Age >60 y | 150 (58.1) | 69 (53.9) | 81 (62.3) | .214 |
| ECOG PS >1 | 34 (13.2) | 17 (13.3) | 17 (13.1) | 1 |
| LDH > ULN | 196 (76.0) | 98 (76.6) | 98 (75.4) | .94 |
| EN >1 | 189 (73.3) | 107 (83.6) | 82 (63.1) | <.001 |
| Stage ≥3 | 214 (82.9) | 113 (88.3) | 101 (77.7) | .036 |
| CNS IPI | ||||
| Low (0-1) | 25 (9.7) | 12 (9.4) | 13 (10.0) | .525 |
| Intermediate (2-3) | 107 (41.5) | 49 (38.3) | 58 (44.6) | |
| High (4-6) or kidney/adrenal involvement | 126 (48.8) | 67 (52.3) | 59 (45.4) | |
| EN >1 and high LDH | 155 (60.1) | 88 (68.8) | 67 (51.5) | .007 |
| High-risk site involvement | ||||
| Yes | 99 (38.4) | 57 (44.5) | 42 (32.3) | .059 |
| Kidney/adrenal | 38 (14.7) | 21 (16.4) | 17 (13.1) | .563 |
| Testicular | 18 (7.0) | 18 (14.1) | 0 (0.0) | <.001 |
| Breast | 23 (8.9) | 10 (7.8) | 13 (10.0) | .691 |
| Paranasal | 18 (7.0) | 6 (4.7) | 12 (9.2) | .235 |
| Epidural | 10 (3.9) | 8 (6.2) | 2 (1.5) | .101 |
| HIV | ||||
| Negative | 254 (98.4) | 126 (98.4) | 128 (98.4) | .513 |
| Positive | 3 (1.2) | 2 (1.6) | 1 (0.8) | |
| Unknown | 1 (0.4) | 0 (0.0) | 1 (0.8) | |
| Cell of origin | ||||
| GCB | 80 (31.0) | 36 (28.1) | 44 (33.8) | .545 |
| Non-GCB | 166 (64.3) | 85 (66.4) | 81 (62.4) | |
| Unknown | 12 (4.7) | 7 (5.5) | 5 (3.8) | |
| Double expressor | ||||
| No | 123 (47.6) | 63 (49.2) | 60 (46.1) | .845 |
| Yes | 115 (44.6) | 56 (43.8) | 59 (45.4) | |
| With IPI ≥2 | 107 (93.0) | 54 (96.4) | 53 (89.8) | |
| Unknown | 20 (7.8) | 9 (7.0) | 11 (8.5) | |
| Double hit | ||||
| No | 5 (1.9) | 2 (1.6) | 3 (2.3) | .813 |
| Yes | 43 (16.7) | 20 (15.6) | 23 (17.7) | |
| Unknown | 210 (81.4) | 106 (82.8) | 104 (80.0) |
| Characteristics . | Overall population (N = 258) . | ITT HD-MTX (n = 128) . | Non-ITT HD-MTX (n = 130) . | P . |
|---|---|---|---|---|
| Age, median (range), y | 62 (25-79) | 61 (25-79) | 65 (29-79) | .059 |
| Sex | ||||
| Male | 146 (56.6) | 83 (64.8) | 63 (48.5) | .011 |
| Female | 112 (43.4) | 45 (35.2) | 67 (51.5) | |
| IPI risk | ||||
| Low (0-1) | 27 (10.4) | 12 (9.4) | 15 (11.5) | .395 |
| Low-intermediate (2) | 41 (15.9) | 16 (12.5) | 25 (19.2) | |
| High-intermediate (3) | 90 (34.9) | 46 (35.9) | 44 (33.9) | |
| High (4-5) | 100 (38.8) | 54 (42.2) | 46 (35.4) | |
| IPI risk factors | ||||
| Age >60 y | 150 (58.1) | 69 (53.9) | 81 (62.3) | .214 |
| ECOG PS >1 | 34 (13.2) | 17 (13.3) | 17 (13.1) | 1 |
| LDH > ULN | 196 (76.0) | 98 (76.6) | 98 (75.4) | .94 |
| EN >1 | 189 (73.3) | 107 (83.6) | 82 (63.1) | <.001 |
| Stage ≥3 | 214 (82.9) | 113 (88.3) | 101 (77.7) | .036 |
| CNS IPI | ||||
| Low (0-1) | 25 (9.7) | 12 (9.4) | 13 (10.0) | .525 |
| Intermediate (2-3) | 107 (41.5) | 49 (38.3) | 58 (44.6) | |
| High (4-6) or kidney/adrenal involvement | 126 (48.8) | 67 (52.3) | 59 (45.4) | |
| EN >1 and high LDH | 155 (60.1) | 88 (68.8) | 67 (51.5) | .007 |
| High-risk site involvement | ||||
| Yes | 99 (38.4) | 57 (44.5) | 42 (32.3) | .059 |
| Kidney/adrenal | 38 (14.7) | 21 (16.4) | 17 (13.1) | .563 |
| Testicular | 18 (7.0) | 18 (14.1) | 0 (0.0) | <.001 |
| Breast | 23 (8.9) | 10 (7.8) | 13 (10.0) | .691 |
| Paranasal | 18 (7.0) | 6 (4.7) | 12 (9.2) | .235 |
| Epidural | 10 (3.9) | 8 (6.2) | 2 (1.5) | .101 |
| HIV | ||||
| Negative | 254 (98.4) | 126 (98.4) | 128 (98.4) | .513 |
| Positive | 3 (1.2) | 2 (1.6) | 1 (0.8) | |
| Unknown | 1 (0.4) | 0 (0.0) | 1 (0.8) | |
| Cell of origin | ||||
| GCB | 80 (31.0) | 36 (28.1) | 44 (33.8) | .545 |
| Non-GCB | 166 (64.3) | 85 (66.4) | 81 (62.4) | |
| Unknown | 12 (4.7) | 7 (5.5) | 5 (3.8) | |
| Double expressor | ||||
| No | 123 (47.6) | 63 (49.2) | 60 (46.1) | .845 |
| Yes | 115 (44.6) | 56 (43.8) | 59 (45.4) | |
| With IPI ≥2 | 107 (93.0) | 54 (96.4) | 53 (89.8) | |
| Unknown | 20 (7.8) | 9 (7.0) | 11 (8.5) | |
| Double hit | ||||
| No | 5 (1.9) | 2 (1.6) | 3 (2.3) | .813 |
| Yes | 43 (16.7) | 20 (15.6) | 23 (17.7) | |
| Unknown | 210 (81.4) | 106 (82.8) | 104 (80.0) |
Data are n (%), unless otherwise noted. ECOG PS, Eastern Cooperative Oncology Group performance status; EN, extranodal sites involved; GCB, germinal center B-cell like; ULN, upper limit of normal.