Table 1.
Patient characteristics
| Variable | Phenytoin | Alternative AEM |
|---|---|---|
| Number of patients | 1460 | 695 |
| Number of centers | 72 | 59 |
| Patient age, median (range) years | 46 (<1–70) | 47 (<1–71) |
| >18 years, N (%) | 1310 (90) | 572 (82) |
| <18 years, N (%) | 150(10) | 123(18) |
| Male sex, N (%) | 781 (53) | 354 (51) |
| Disease, N (%) | ||
| AML | 799 (55) | 471 (68) |
| MDS | 318 (22) | 126(18) |
| CML | 212 (15) | 63 (9) |
| NHL | 47 (3) | 7 (1) |
| ALL | 39 (3) | 12 (2) |
| Othera | 45 (3) | 16 (3) |
| Donor type, N (%) | ||
| HLA-identical sibling | 498 (34) | 237 (34) |
| Unrelated or umbilical cord blood | 962 (66) | 458 (66) |
| Graft type, N (%) | ||
| Growth factor-mobilized blood | 950 (65) | 481 (69) |
| Bone marrow | 445 (30) | 158 (23) |
| Umbilical cord blood | 65 (4) | 56 (8) |
| BU administration route,b N (%) | ||
| IV | 1130 (77) | 637 (92) |
| Oral | 318 (22) | 57 (8) |
| BU cumulative dose (mg/kg),dmedian (range) | 13 (8–37) | 13 (8–26) |
| BU pharmacokinetics obtained, N (%) | ||
| Missing | 740 (51) | 164 (24) |
| No | 414 (28) | 173 (25) |
| Yes | 306 (21) | 358 (52) |
| CY cumulative dose (mg/kg), median (range) | 120 (100–247) | 120 (101–278) |
| 100–130, N (%) | 1252(86) | 576 (83) |
| 131–170, N (%) | 59 (4) | 22 (3) |
| 171–186, N (%) | 16 (1) | 3 (<1) |
| 187–278, N (%) | 133 (9) | 94(14) |
| Median follow-up of survivors (range), months | 73 (3–139) | 61 (3–123) |
Abbreviations: AEM, anti-epileptic medication; N, number; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; CML, chronic myeloid leukemia; NHL, non-Hodgkin lymphoma; ALL, acute lymphoblastic leukemia; BU, busulfan; IV, intravenous, CY, cyclophosphamide.
a
Hodgkin disease, myeloproliferative syndrome, myeloma and other leukemia.
b
Information regarding BU administration route was not available for 12 patients in the phenytoin group and 1 patient in the alternative AEM group.
c
Doses greater than 8 mg/kg BU - either oral or IV - were used.