Historically controlled and uncontrolled clinical trials of primary antifungal prophylaxis
| Prophylactic regimen and daily dose/study arm . | No. . | Underlying disease . | Allo/auto SCT, % . | Invasive fungal infections/ study arm, % . | Mortality, % . | |||
|---|---|---|---|---|---|---|---|---|
| Proven . | Probable . | Possible . | Overall . | Attributable . | ||||
| Böhme and Hoelzer575-150 | ||||||||
| AmB 0.5 mg/kg 3x/wk IV | 61 | 87% AML, 9% ALL, 4% other hematol | NA | 0 | 9.3 | 1.6 | NA | NA |
| ITR oral sol 400 mg | 72 | 16.7 | 8.3 | 4.1 | NA | NA | ||
| Karthaus et al565-150 | ||||||||
| AmB 1 mg/kg/48 h | 104 | 100% AL | NA | 0 | 18.3 | 12.5 | NA | NA |
| No prophylaxis | 104 | 4.8 | 34.6 | 19.2 | NA | NA | ||
| Rousey et al845-150 | ||||||||
| AmB 20 mg IV + LAF | 110 | 24% AML, 8% ALL, 44% CML, | 100/0 | 9 | NA | NA | 20 | 6 |
| LAF | 48 | 24% other hematol | 23 | NA | NA | 35 | 13 | |
| No prophylaxis | 28 | 25 | NA | NA | 46 | 18 | ||
| Alangaden et al855-150 | ||||||||
| FLU 100/200 mg | 112 | 50% AL, 36% NHL/HD, 15% other | 67/33 | 3.6 | NA | NA | 8.9 | 0.9 |
| No prophylaxis | 79 | 10.1 | NA | NA | 17.7 | 3.8 | ||
| Takatsuka et al865-150 | ||||||||
| FLU 200 mg + AmB oral sol 300 mg + AmB inhalation, dose NA | 54 | 46% AML, 18% ALL, 19% NHL, 5% CML | NA | 0 | NA | NA | NA | NA |
| AmB 300 mg PO + oral sol 300 mg + inhalation, dose NA | 70 | 7 | NA | NA | NA | NA | ||
| Glasmacher et al395-150 | ||||||||
| ITR caps 400/600 mg + AmB oral sol 2400 mg or NYS 24 × 106IU | 47 | ≈85% AML, ≈15% ALL, ≈22% AL relapse | NA | NA | NA | NA | 17.9 | 0.9 |
| AmB oral sol 2400 mg or NYS 24 × 106IU | 76 | NA | NA | NA | NA | 25 | 8.8 | |
| Böhme et al425-150 | ||||||||
| ITR caps 400 mg | 241 | 65% AML, 12% ALL, 23% other hematol | NA | 4.6 | 0.5 | 1.5 | NA | NA |
| AmB 800 mg PO | 223 | 5.4 | 0.9 | 1.3 | NA | NA | ||
| Tricot et al875-150 | ||||||||
| ITR caps 400 mg | 45 | 68% AML, 26% ALL, 6% other hematol | NA | 24 | 5.5 | NA | 24 | 15.5 |
| KTC 400 mg | 52 | 44.5 | 8.5 | NA | 40.5 | 36.5 | ||
| Thunnissen et al885-150 | ||||||||
| ITR caps 400 mg | 47 | 75% AML, 25% ALL/NHL | NA | 0 | NA | NA | 8.5 | 0 |
| NYS 10 × 106IU | 47 | 9 | NA | NA | 26 | 13 | ||
| Annaloro et al835-151 | ||||||||
| ITR caps 400 mg + NYS, dose NA | 31 | 12.9 | 3.25-152 | 6.4 | 0 | |||
| FLU 300 mg + NYS, dose NA | 28 | NA | 35/65 | 3.6 | 7.1 | 7.1 | 0 | |
| FLU 50 mg NYS, dose NA | 30 | 3.3 | 6.6 | 3.3 | 0 | |||
| Hertenstein et al505-153 | ||||||||
| AmB 20 mg inhalation | 303 | 55% AML, 26% CML, 19% other | 89/9 | 3.6 | NA | NA | 20.5 | 2.6 |
| Erjavec et al515-152 | ||||||||
| AmB 30 mg inhalation | 42 | 52% AML, 41% ALL, 7% other hematol | NA | 14 | 14 | NA | NA | 7.1 |
| Lamy et al895-152 | ||||||||
| ITR caps 400 mg + LAF | 96 | 45% AML, 10% ALL, 45% other hematol | NA | 2 | 3 | NA | NA | 0 |
| Prophylactic regimen and daily dose/study arm . | No. . | Underlying disease . | Allo/auto SCT, % . | Invasive fungal infections/ study arm, % . | Mortality, % . | |||
|---|---|---|---|---|---|---|---|---|
| Proven . | Probable . | Possible . | Overall . | Attributable . | ||||
| Böhme and Hoelzer575-150 | ||||||||
| AmB 0.5 mg/kg 3x/wk IV | 61 | 87% AML, 9% ALL, 4% other hematol | NA | 0 | 9.3 | 1.6 | NA | NA |
| ITR oral sol 400 mg | 72 | 16.7 | 8.3 | 4.1 | NA | NA | ||
| Karthaus et al565-150 | ||||||||
| AmB 1 mg/kg/48 h | 104 | 100% AL | NA | 0 | 18.3 | 12.5 | NA | NA |
| No prophylaxis | 104 | 4.8 | 34.6 | 19.2 | NA | NA | ||
| Rousey et al845-150 | ||||||||
| AmB 20 mg IV + LAF | 110 | 24% AML, 8% ALL, 44% CML, | 100/0 | 9 | NA | NA | 20 | 6 |
| LAF | 48 | 24% other hematol | 23 | NA | NA | 35 | 13 | |
| No prophylaxis | 28 | 25 | NA | NA | 46 | 18 | ||
| Alangaden et al855-150 | ||||||||
| FLU 100/200 mg | 112 | 50% AL, 36% NHL/HD, 15% other | 67/33 | 3.6 | NA | NA | 8.9 | 0.9 |
| No prophylaxis | 79 | 10.1 | NA | NA | 17.7 | 3.8 | ||
| Takatsuka et al865-150 | ||||||||
| FLU 200 mg + AmB oral sol 300 mg + AmB inhalation, dose NA | 54 | 46% AML, 18% ALL, 19% NHL, 5% CML | NA | 0 | NA | NA | NA | NA |
| AmB 300 mg PO + oral sol 300 mg + inhalation, dose NA | 70 | 7 | NA | NA | NA | NA | ||
| Glasmacher et al395-150 | ||||||||
| ITR caps 400/600 mg + AmB oral sol 2400 mg or NYS 24 × 106IU | 47 | ≈85% AML, ≈15% ALL, ≈22% AL relapse | NA | NA | NA | NA | 17.9 | 0.9 |
| AmB oral sol 2400 mg or NYS 24 × 106IU | 76 | NA | NA | NA | NA | 25 | 8.8 | |
| Böhme et al425-150 | ||||||||
| ITR caps 400 mg | 241 | 65% AML, 12% ALL, 23% other hematol | NA | 4.6 | 0.5 | 1.5 | NA | NA |
| AmB 800 mg PO | 223 | 5.4 | 0.9 | 1.3 | NA | NA | ||
| Tricot et al875-150 | ||||||||
| ITR caps 400 mg | 45 | 68% AML, 26% ALL, 6% other hematol | NA | 24 | 5.5 | NA | 24 | 15.5 |
| KTC 400 mg | 52 | 44.5 | 8.5 | NA | 40.5 | 36.5 | ||
| Thunnissen et al885-150 | ||||||||
| ITR caps 400 mg | 47 | 75% AML, 25% ALL/NHL | NA | 0 | NA | NA | 8.5 | 0 |
| NYS 10 × 106IU | 47 | 9 | NA | NA | 26 | 13 | ||
| Annaloro et al835-151 | ||||||||
| ITR caps 400 mg + NYS, dose NA | 31 | 12.9 | 3.25-152 | 6.4 | 0 | |||
| FLU 300 mg + NYS, dose NA | 28 | NA | 35/65 | 3.6 | 7.1 | 7.1 | 0 | |
| FLU 50 mg NYS, dose NA | 30 | 3.3 | 6.6 | 3.3 | 0 | |||
| Hertenstein et al505-153 | ||||||||
| AmB 20 mg inhalation | 303 | 55% AML, 26% CML, 19% other | 89/9 | 3.6 | NA | NA | 20.5 | 2.6 |
| Erjavec et al515-152 | ||||||||
| AmB 30 mg inhalation | 42 | 52% AML, 41% ALL, 7% other hematol | NA | 14 | 14 | NA | NA | 7.1 |
| Lamy et al895-152 | ||||||||
| ITR caps 400 mg + LAF | 96 | 45% AML, 10% ALL, 45% other hematol | NA | 2 | 3 | NA | NA | 0 |
KTC indicates ketoconazole. Other abbreviations are defined in Tables 2, 3, and 4 notes.
Authors used a historic control design.
Annaloro et al83 used a randomized historic control design.
Data between “Probable” column and “Possible” column indicate cases deemed “probable or possible” in studies in which no distinction was made between the two categories of likelihood.
Authors used no control in their design.