Table II.
Regimen-related toxicities by route of busulfan administration*.
| Oral busulfan n = 72 |
i.v. busulfan n = 59 |
Combined n = 131 |
|
|---|---|---|---|
| Total bilirubin elevation grade† | |||
| 0 | 43% (31) | 58% (34) | 50% (65) |
| 1 | 25% (18) | 25% (15) | 25% (33) |
| 2 | 25% (18) | 12% (7) | 19% (25) |
| 3 | 6% (4) | 5% (3) | 5% (7) |
| 4 | 1% (1) | 0% (0) | 1% (1) |
| AST elevation grade† | |||
| 0 | 43% (31) | 14% (8) | 30% (39) |
| 1 | 42% (30) | 61% (36) | 50% (66) |
| 2 | 8% (6) | 17% (10) | 12% (16) |
| 3 | 7% (5) | 8% (5) | 8% (10) |
| 4 | 0% (0) | 0% (0) | 0% (0) |
| ALT elevation grade† | |||
| 0 | 25% (18) | 14% (8) | 20% (26) |
| 1 | 57% (41) | 49% (29) | 53% (70) |
| 2 | 7% (5) | 20% (12) | 13% (17) |
| 3 | 11% (8) | 15% (9) | 13% (17) |
| 4 | 0% (0) | 2% (1) | 1% (1) |
| VOD‡ | |||
| No | 90% (65) | 98% (58) | 94% (123) |
| Yes | 10% (7) | 2% (1) | 6% (8) |
| VOD grade# | |||
| None | 90% (65) | 98% (58) | 94% (123) |
| Mild | 3% (2) | 2% (1) | 2% (3) |
| Moderate | 4% (3) | 0% (0) | 2% (3) |
| Severe | 3% (2) | 0% (0) | 2% (2) |
| Acute GVHD§ | |||
| None or Grade I | 60% (43) | 41% (24) | 51% (67) |
| Grade II | 26% (19) | 37% (22) | 31% (41) |
| Grade III– IV | 14% (10) | 22% (13) | 18% (23) |
*
Given the non-randomized study design, changes in clinical practice over time, and differences in the donor relatedness for each group, significance testing by route of administration was not performed (see text for comparisons after stratifying by donor relatedness).
†
Through the first 20 days post-transplant. Graded by the Common Terminology Criteria for Adverse Events, version 4.0.
‡
Diagnosed per the Baltimore Criteria [19].
#
Graded per the McDonald Criteria [21].
§
Graded per the Keystone Criteria [22].
AST, aspartate aminotransferase; ALT, alanine aminotransferase; VOD, veno-occlusive disease; GVHD, graft-versus-host disease.