Baseline characteristics
| Variable . | HDMTX-P (n = 84 patients), % . | HDMTX-T (n = 56 patients), % . | Overall (n = 140 patients), % . |
|---|---|---|---|
| Age, median (range) | 58 (19-76) | 62 (19-80) | 60 (19-80) |
| Male gender | 57 (68) | 32 (57) | 89 (64) |
| ECOG performance status | |||
| 0-1 | 75 (91) | 32 (64) | 107 (76) |
| 2 | 5 (6) | 12 (24) | 17 (13) |
| 3 | 2 (2) | 6 (12) | 8 (6) |
| Unknown | 2 | 6 | 8 |
| Lymphoma subtype | |||
| DLBCL | 79 (94) | 41 (73) | 120 (86) |
| HGBCL | 5 (6) | 9 (16) | 14 (10) |
| T-cell lymphoma | 0 | 3 (5) | 3 (2) |
| Primary CNS lymphoma | 0 | 1 (2) | 1 (1) |
| Mantle cell lymphoma | 0 | 2 (4) | 2 (1) |
| MYC, BCL2, BCL6 by FISH | |||
| Double-hit (MYC and BCL2 or BCL6) | 2 (2) | 5 (9) | 7 (5) |
| Triple-hit (MYC, BCL2, and BCL6) | 0 | 1 (2) | 1 (1) |
| Unknown | 14 | 13 | 27 |
| MYC/BCL2 double expression by IHC | |||
| Present | 27 (50) | 11 (55) | 38 (51) |
| Absent | 27 (50) | 9 (45) | 36 (49) |
| Unknown | 30 | 36 | 66 |
| LDH >upper limit of normal | 61 (73) | 44 (86) | 105 (78) |
| Unknown | 1 | 5 | 6 |
| Stage IV | 78 (93) | 54 (96) | 132 (94) |
| No. of extranodal sites, median (range) | 2 (0-9) | 2 (1-7) | 2 (0-9) |
| ≥2 extranodal sites | 65 (77) | 43 (77) | 108 (77) |
| ≥3 extranodal sites | 31 (37) | 27 (48) | 58 (41) |
| Extranodal sites | |||
| Renal/adrenal | 25 (30) | 7 (13) | 32 (23) |
| Paraspinal | 16 (19) | 6 (11) | 22 (16) |
| Paranasal sinus | 10 (12) | 2 (4) | 12 (9) |
| Testicular | 8 (10) | 4 (7) | 12 (9) |
| Breast | 3 (4) | 2 (4) | 5 (4) |
| Ovarian | 1 (1) | 0 | 1 (1) |
| IPI score | |||
| Low-risk (0-1) | 7 (8) | 3 (7) | 10 (8) |
| Intermediate-risk (2-3) | 50 (60) | 17 (38) | 67 (52) |
| High-risk (4-5) | 26 (31) | 25 (55) | 51 (40) |
| Unknown | 1 (1) | 11 (20) | 12 (9) |
| CNS-IPI | |||
| Low-risk (0-1) | 7 (8) | — | — |
| Intermediate-risk (2-3) | 36 (43) | ||
| High-risk (4-6) | 40 (48) | ||
| Unknown | 1 (1) | ||
| Laboratory parameters (cycle 1 d 1) | |||
| Albumin ≥3.5 g/dL, unknown | 29 (60), 36 | 11 (26), 14 | 40 (44), 50 |
| Hemoglobin ≥10.0 g/dL, unknown | 56 (75), 9 | 31 (62), 6 | 87 (70), 15 |
| Platelets ≥150 K/μL, unknown | 60 (80), 9 | 35 (70), 6 | 95 (76), 15 |
| ANC ≥1500 cells/μL, unknown | 67 (94), 13 | 45 (90), 6 | 112 (93), 19 |
| Creatinine clearance (mL/min), median (range) | 107 (48-340) | 106 (31-366) | 107 (31-336) |
| Variable . | HDMTX-P (n = 84 patients), % . | HDMTX-T (n = 56 patients), % . | Overall (n = 140 patients), % . |
|---|---|---|---|
| Age, median (range) | 58 (19-76) | 62 (19-80) | 60 (19-80) |
| Male gender | 57 (68) | 32 (57) | 89 (64) |
| ECOG performance status | |||
| 0-1 | 75 (91) | 32 (64) | 107 (76) |
| 2 | 5 (6) | 12 (24) | 17 (13) |
| 3 | 2 (2) | 6 (12) | 8 (6) |
| Unknown | 2 | 6 | 8 |
| Lymphoma subtype | |||
| DLBCL | 79 (94) | 41 (73) | 120 (86) |
| HGBCL | 5 (6) | 9 (16) | 14 (10) |
| T-cell lymphoma | 0 | 3 (5) | 3 (2) |
| Primary CNS lymphoma | 0 | 1 (2) | 1 (1) |
| Mantle cell lymphoma | 0 | 2 (4) | 2 (1) |
| MYC, BCL2, BCL6 by FISH | |||
| Double-hit (MYC and BCL2 or BCL6) | 2 (2) | 5 (9) | 7 (5) |
| Triple-hit (MYC, BCL2, and BCL6) | 0 | 1 (2) | 1 (1) |
| Unknown | 14 | 13 | 27 |
| MYC/BCL2 double expression by IHC | |||
| Present | 27 (50) | 11 (55) | 38 (51) |
| Absent | 27 (50) | 9 (45) | 36 (49) |
| Unknown | 30 | 36 | 66 |
| LDH >upper limit of normal | 61 (73) | 44 (86) | 105 (78) |
| Unknown | 1 | 5 | 6 |
| Stage IV | 78 (93) | 54 (96) | 132 (94) |
| No. of extranodal sites, median (range) | 2 (0-9) | 2 (1-7) | 2 (0-9) |
| ≥2 extranodal sites | 65 (77) | 43 (77) | 108 (77) |
| ≥3 extranodal sites | 31 (37) | 27 (48) | 58 (41) |
| Extranodal sites | |||
| Renal/adrenal | 25 (30) | 7 (13) | 32 (23) |
| Paraspinal | 16 (19) | 6 (11) | 22 (16) |
| Paranasal sinus | 10 (12) | 2 (4) | 12 (9) |
| Testicular | 8 (10) | 4 (7) | 12 (9) |
| Breast | 3 (4) | 2 (4) | 5 (4) |
| Ovarian | 1 (1) | 0 | 1 (1) |
| IPI score | |||
| Low-risk (0-1) | 7 (8) | 3 (7) | 10 (8) |
| Intermediate-risk (2-3) | 50 (60) | 17 (38) | 67 (52) |
| High-risk (4-5) | 26 (31) | 25 (55) | 51 (40) |
| Unknown | 1 (1) | 11 (20) | 12 (9) |
| CNS-IPI | |||
| Low-risk (0-1) | 7 (8) | — | — |
| Intermediate-risk (2-3) | 36 (43) | ||
| High-risk (4-6) | 40 (48) | ||
| Unknown | 1 (1) | ||
| Laboratory parameters (cycle 1 d 1) | |||
| Albumin ≥3.5 g/dL, unknown | 29 (60), 36 | 11 (26), 14 | 40 (44), 50 |
| Hemoglobin ≥10.0 g/dL, unknown | 56 (75), 9 | 31 (62), 6 | 87 (70), 15 |
| Platelets ≥150 K/μL, unknown | 60 (80), 9 | 35 (70), 6 | 95 (76), 15 |
| ANC ≥1500 cells/μL, unknown | 67 (94), 13 | 45 (90), 6 | 112 (93), 19 |
| Creatinine clearance (mL/min), median (range) | 107 (48-340) | 106 (31-366) | 107 (31-336) |