Characteristics of the patients and outcomes
| Patient characteristics* . | Fluconazole (N = 295) . | Voriconazole (N = 305) . |
|---|---|---|
| Median age, y (range) | 43 (9-65) | 43 (2.7-65.7) |
| Patients 18 years or above, n (%) | 271 (92) | 278 (91) |
| Male sex, n (%) | 161 (55) | 170 (56) |
| White race, n (%) | 265 (90) | 276 (91) |
| Underlying disease, n (%) | ||
| Acute myeloid leukemia | 101 (34) | 133 (44) |
| Acute lymphoblastic leukemia | 64 (22) | 58 (19) |
| Chronic myelogeneous leukemia | 60 (20) | 43 (14) |
| Myelodysplastic syndrome | 49 (17) | 49 (16) |
| Non-Hodgkin lymphoma | 21 (7) | 22 (7) |
| CIBMTR disease risk status | ||
| Standard | 263 (89) | 283 (93) |
| Poor | 32 (11) | 22 (7) |
| Transplant type | ||
| Matched related, n (%) | 167 (57) | 167 (55) |
| Mismatched related, n (%) | 2 (1) | 1 (< 1) |
| Matched unrelated, n (%) | 115 (39) | 126 (41) |
| Mismatched unrelated, n (%) | 11 (4) | 11 (4) |
| HLA match, n (%) | ||
| 6/6 | 282 (96) | 293 (96) |
| 5/6 | 13 (4) | 12 (4) |
| Graft manipulation to remove T cells, n (%) | 9 (3.1) | 15 (4.9) |
| Graft source | ||
| Bone marrow | 109 (37) | 106 (35) |
| Peripheral blood | 186 (63) | 197 (65) |
| Cord blood | 0 (0) | 2 (< 1) |
| CMV seropositivity, n (%) | 151 (51) | 157 (52) |
| Karnofsky/Lansky performance status 90% or 100%, n (%) | 249 (84) | 268 (88) |
| Posttransplantation parameters | ||
| Failure to engraft (by day 42) | 11 (5) | 9 (5) |
| Cumulative incidence of acute GVHD (II-IV) at day 100, n (%) | 132 (53) | 116 (46) |
| Cumulative incidence of acute GVHD (III-IV) at day 100, n (%) | 42 (16) | 27 (13) |
| Cumulative incidence of chronic GVHD at 1 year, n (%) | 138 (47) | 137 (46) |
| Cumulative incidence of relapse/progression at day 180, n (%) | 39 (7.5) | 48 (11.3) |
| Nonfungal infections, n (% of patients) | ||
| Bacterial | 172 (58) | 185 (61) |
| Viral | 110 (37) | 103 (34) |
| Patient characteristics* . | Fluconazole (N = 295) . | Voriconazole (N = 305) . |
|---|---|---|
| Median age, y (range) | 43 (9-65) | 43 (2.7-65.7) |
| Patients 18 years or above, n (%) | 271 (92) | 278 (91) |
| Male sex, n (%) | 161 (55) | 170 (56) |
| White race, n (%) | 265 (90) | 276 (91) |
| Underlying disease, n (%) | ||
| Acute myeloid leukemia | 101 (34) | 133 (44) |
| Acute lymphoblastic leukemia | 64 (22) | 58 (19) |
| Chronic myelogeneous leukemia | 60 (20) | 43 (14) |
| Myelodysplastic syndrome | 49 (17) | 49 (16) |
| Non-Hodgkin lymphoma | 21 (7) | 22 (7) |
| CIBMTR disease risk status | ||
| Standard | 263 (89) | 283 (93) |
| Poor | 32 (11) | 22 (7) |
| Transplant type | ||
| Matched related, n (%) | 167 (57) | 167 (55) |
| Mismatched related, n (%) | 2 (1) | 1 (< 1) |
| Matched unrelated, n (%) | 115 (39) | 126 (41) |
| Mismatched unrelated, n (%) | 11 (4) | 11 (4) |
| HLA match, n (%) | ||
| 6/6 | 282 (96) | 293 (96) |
| 5/6 | 13 (4) | 12 (4) |
| Graft manipulation to remove T cells, n (%) | 9 (3.1) | 15 (4.9) |
| Graft source | ||
| Bone marrow | 109 (37) | 106 (35) |
| Peripheral blood | 186 (63) | 197 (65) |
| Cord blood | 0 (0) | 2 (< 1) |
| CMV seropositivity, n (%) | 151 (51) | 157 (52) |
| Karnofsky/Lansky performance status 90% or 100%, n (%) | 249 (84) | 268 (88) |
| Posttransplantation parameters | ||
| Failure to engraft (by day 42) | 11 (5) | 9 (5) |
| Cumulative incidence of acute GVHD (II-IV) at day 100, n (%) | 132 (53) | 116 (46) |
| Cumulative incidence of acute GVHD (III-IV) at day 100, n (%) | 42 (16) | 27 (13) |
| Cumulative incidence of chronic GVHD at 1 year, n (%) | 138 (47) | 137 (46) |
| Cumulative incidence of relapse/progression at day 180, n (%) | 39 (7.5) | 48 (11.3) |
| Nonfungal infections, n (% of patients) | ||
| Bacterial | 172 (58) | 185 (61) |
| Viral | 110 (37) | 103 (34) |
None of the differences were significant.
CMV indicates cytomegalovirus; and GVHD, graft-versus-host disease.
There were 8 patients entered into the trial who were not eligible. Six were assigned to the fluconazole arm and 2 to the voriconazole arm. The reasons for ineligibility were as follows: noneligible diagnosis or conditioning regimen in 3; abnormal hepatic functioning test in 1; incomplete baseline evaluation to exclude subclinical fungal infection in 2; the need for starting empiric antifungal therapy during the conditioning regimen in 1; and evidence of a prior fungal infection in 1. Because this was an intent-to-treat analysis, all were included in the analyses reported.