Patient-level toxicity data
| Variable . | HDMTX-P (n = 84 patients), % . | HDMTX-T (n = 56 patients), % . | Overall (n = 140 patients), % . |
|---|---|---|---|
| ≥1 cycle delayed ≥7 d due to toxicity | 10 (12) | 8 (14) | 18 (13) |
| No. of cycles delayed ≥7 d/patient | |||
| 0 | 71 (88) | 43 (84) | 114 (86) |
| 1 | 9 (11) | 6 (12) | 15 (11) |
| 2 | 1 (1) | 0 | 1 (1) |
| 3 | 0 | 2 (4) | 2 (2) |
| Unknown/missing | 3 | 5 | 8 |
| ≥1 cycle with dose reduction of doxorubicin and/or cyclophosphamide | 3 (4) | 5 (9) | 8 (6) |
| ≥1 cycle with dose reduction of HDMTX | 4 (5) | 8 (14) | 12 (9) |
| (R)CHOP prematurely discontinued | 7 (8) | 16 (29) | 23 (16) |
| Toxicity | 4 (5) | 1 (2) | 5 (4) |
| Progression | 0 | 3 (5) | 3 (2) |
| Death/hospice | 1 (1) | 8 (14) | 9 (6) |
| Alternate therapy | 1 (1) | 3 (5) | 4 (3) |
| Lost to follow up | 1 (1) | 1 (2) | 2 (1) |
| HDMTX prematurely discontinued* | 11 (13) | 5 (9) | 16 (11) |
| Toxicity | 11 (13) | 4 (7) | 15 (11) |
| Progression | 0 (0) | 1 (2) | 1 (1) |
| NF | 18 (21) | 15 (27) | 33 (24) |
| AKI†‡ | |||
| Any grade | 32 (38) | 29 (52) | 61 (44) |
| Grade 1 (>ULN - 1.5 × ULN) | 14 (17) | 7 (13) | 21 (15) |
| Grade 2 (>1.5 - 3.0 ULN) | 21 (25) | 20 (36) | 41 (29) |
| Grade 3 (>3.0 - 6.0 ULN) | 3 (4) | 7 (13) | 10 (7) |
| Grade 4 (>6.0 ULN) | 0 (0) | 2 (4) | 2 (1) |
| Glucarpidase administered | 3 (4) | 5 (9) | 8 (6) |
| ALT/AST increase, grade ≥3† | 5 (6) | 4 (7) | 9 (6) |
| Bilirubin increase, grade ≥3† | 0 (0) | 1 (2) | 1 (1) |
| Mucositis, grade ≥3 | 6 (7) | 8 (14) | 14 (10) |
| Variable . | HDMTX-P (n = 84 patients), % . | HDMTX-T (n = 56 patients), % . | Overall (n = 140 patients), % . |
|---|---|---|---|
| ≥1 cycle delayed ≥7 d due to toxicity | 10 (12) | 8 (14) | 18 (13) |
| No. of cycles delayed ≥7 d/patient | |||
| 0 | 71 (88) | 43 (84) | 114 (86) |
| 1 | 9 (11) | 6 (12) | 15 (11) |
| 2 | 1 (1) | 0 | 1 (1) |
| 3 | 0 | 2 (4) | 2 (2) |
| Unknown/missing | 3 | 5 | 8 |
| ≥1 cycle with dose reduction of doxorubicin and/or cyclophosphamide | 3 (4) | 5 (9) | 8 (6) |
| ≥1 cycle with dose reduction of HDMTX | 4 (5) | 8 (14) | 12 (9) |
| (R)CHOP prematurely discontinued | 7 (8) | 16 (29) | 23 (16) |
| Toxicity | 4 (5) | 1 (2) | 5 (4) |
| Progression | 0 | 3 (5) | 3 (2) |
| Death/hospice | 1 (1) | 8 (14) | 9 (6) |
| Alternate therapy | 1 (1) | 3 (5) | 4 (3) |
| Lost to follow up | 1 (1) | 1 (2) | 2 (1) |
| HDMTX prematurely discontinued* | 11 (13) | 5 (9) | 16 (11) |
| Toxicity | 11 (13) | 4 (7) | 15 (11) |
| Progression | 0 (0) | 1 (2) | 1 (1) |
| NF | 18 (21) | 15 (27) | 33 (24) |
| AKI†‡ | |||
| Any grade | 32 (38) | 29 (52) | 61 (44) |
| Grade 1 (>ULN - 1.5 × ULN) | 14 (17) | 7 (13) | 21 (15) |
| Grade 2 (>1.5 - 3.0 ULN) | 21 (25) | 20 (36) | 41 (29) |
| Grade 3 (>3.0 - 6.0 ULN) | 3 (4) | 7 (13) | 10 (7) |
| Grade 4 (>6.0 ULN) | 0 (0) | 2 (4) | 2 (1) |
| Glucarpidase administered | 3 (4) | 5 (9) | 8 (6) |
| ALT/AST increase, grade ≥3† | 5 (6) | 4 (7) | 9 (6) |
| Bilirubin increase, grade ≥3† | 0 (0) | 1 (2) | 1 (1) |
| Mucositis, grade ≥3 | 6 (7) | 8 (14) | 14 (10) |