TABLE 2.
Relationships of lower and upper limits of voriconazole trough concentration to outcomes and adverse events identified from ROC curve analysis
| Treatment outcome or adverse event | No. (%) of patients with voriconazole trough level of: |
P value | Odds ratio (95% CI) | |||
|---|---|---|---|---|---|---|
| <1.3 μg/ml (n = 34) | ≥1.3 μg/ml (n = 70) | ≤5.3 μg/ml (n = 80) | >5.3 μg/ml (n = 24) | |||
| Treatment outcomes | ||||||
| Success (n = 70) | 10 (29.4) | 60 (85.7) | 0.005 | |||
| Complete response | 4 (11.8) | 50 (71.4) | 0.004 | 0.05 (0.01–0.28) | ||
| Partial response | 6 (17.6) | 10 (14.3) | 0.79 | 1.29 (0.27–6.15) | ||
| Lack of response (n = 34) | 24 (70.6) | 10 (14.3) | 0.002 | |||
| Progression | 8 (23.5) | 2 (2.9) | 0.06 | 6.8 (0.71–65.16) | ||
| Persistent infection | 4 (11.8) | 2 (2.9) | 0.50 | 4.53 (0.38–53.93) | ||
| Death | 12 (35.3) | 6 (8.5) | 0.046 | 5.81 (1.24–27.3) | ||
| Adverse events | ||||||
| Anya (n = 28) | 10 (12.5) | 18 (75) | <0.001 | 0.05 (0.01–0.23) | ||
| Hallucination | 2 (2.5) | 12 (50) | <0.001 | 0.03 (0.002–0.25) | ||
| Skin rash | 2 (2.5) | 2 (8) | 0.250 | 0.28 (0.02–4.88) | ||
| Nervousness | 4 (5.0) | 6 (25) | 0.070 | 0.16 (0.02–1.09) | ||
| Visual disturbance | 2 (2.5) | 10 (42) | 0.005 | 0.04 (0.004–0.36) | ||
| Gastrointestinal syndrome | 2 (2.5) | 8 (33) | 0.030 | 0.05 (0.005–0.52) | ||
| Hepatotoxicityb | 4 (5.0) | 10 (42) | 0.001 | 0.07 (0.01–0.46) | ||
a
Eight patients had more than one adverse event.
b
Hepatotoxicity was defined as follows: grade 1, elevations in alanine transaminase, aspartate transaminase, and alkaline phosphatase levels of >3.0 times the upper limit of normal; and grade 2, elevations in alanine transaminase, aspartate transaminase, and alkaline phosphatase levels of 3.0 to 5.0 times the upper limit of normal and in the total bilirubin level of >3.0 times the upper limit of normal.