Table 1.
Demographic and clinical characteristics at baseline
| Variable | Standard n = 15 (%) | TDM n = 14 (%) |
|---|---|---|
|
| ||
| Demographics | ||
|
| ||
| Mean age (range) | 59.1 (28–84) | 63.4 (49–83) |
|
| ||
| Mean weight (kg, range) | 74.3 (45–103) | 86.6 (48–118) |
| Ethnicity | ||
| White | 14 (93) | 14 (100) |
| Hispanic | 1 (7) | 0 |
|
| ||
| Gender, Female | 5 (33) | 5 (36) |
|
| ||
| Medical conditions, n (%) | ||
|
| ||
| Underlying disease | ||
| Acute leukemia | 7 (47) | 7 (47) |
| Chronic leukemia | 3 (15) | 4 (27) |
| Lymphoma | 1 (7) | 1 (7) |
| Other solid tumors | 5 (33) | 2 (14) |
|
| ||
| SCT (n = 11) | ||
| Allogeneic, HLA MRD | 4 (27) | 2 (14) |
| Allogeneic, HLA URD / Haploidentical | 1 (7) | 4 (29) |
|
| ||
| Diagnosis of IFI, n (%)1 | ||
|
| ||
| Possible invasive aspergillosis | 11 (73) | 9 (64) |
| Probable invasive aspergillosis | 4 (27) | 3 (21) |
| Proven invasive aspergillosis | 0 | 1 (7) |
|
| ||
| Treatment initiation | ||
|
| ||
| Oral | 10 (77) | 6 (43) |
| Intravenous | 5 (33) | 8 (57) |
| Mean mg/kg at starting dose (range) | 5.6 (2.2–9.1) | 3.9 (2.3–4.5) |
1
One patient in the therapeutic drug monitoring (TDM) arm received the drug without a diagnosis of invasive fungal infection (IFI). This patient was enrolled after the trial was expanded to include patients who received voriconazole as prophylaxis.
SCT, stem cell transplant; HLA, histocompatibility antigen; MRD, matched related donor; URD, unmatched related donor.