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 eventNo. (%) of patients with voriconazole trough level of:P valueOdds 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 response4 (11.8)50 (71.4) 0.0040.05 (0.01–0.28)
        Partial response6 (17.6)10 (14.3) 0.791.29 (0.27–6.15)
    Lack of response (n = 34)24 (70.6)10 (14.3) 0.002
        Progression8 (23.5)2 (2.9) 0.066.8 (0.71–65.16)
        Persistent infection4 (11.8)2 (2.9) 0.504.53 (0.38–53.93)
        Death12 (35.3)6 (8.5) 0.0465.81 (1.24–27.3)
Adverse events
    Anya (n = 28) 10 (12.5)18 (75)<0.0010.05 (0.01–0.23)
    Hallucination 2 (2.5)12 (50)<0.0010.03 (0.002–0.25)
    Skin rash 2 (2.5)2 (8)0.2500.28 (0.02–4.88)
    Nervousness 4 (5.0)6 (25)0.0700.16 (0.02–1.09)
    Visual disturbance 2 (2.5)10 (42)0.0050.04 (0.004–0.36)
    Gastrointestinal syndrome 2 (2.5)8 (33)0.0300.05 (0.005–0.52)
    Hepatotoxicityb 4 (5.0)10 (42)0.0010.07 (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.