TABLE 8.
Overall efficacy based on underlying factors (all randomized patients)
| Underlying factor | Favorable outcome
|
|||
|---|---|---|---|---|
| Persistent febrile neutropenia (n/total)
|
Refractory disease (n[CR:PR]h/total)
|
|||
| Efficacy evaluable (n = 53) | All randomized (n = 66) | Efficacy evaluable (n = 21) | All randomized (n = 32) | |
| Underlying diseasea | ||||
| Leukemia | 32/39 | 33/50 | 9[2:7]/20 | 11[3:8]/32 |
| Non-Hodgkin's lymphoma | 6/7 | 6/8 | 0/1 | 0/1 |
| Myelodysplastic syndrome | 2/5 | 2/6 | 1[0:1]/3 | 1[0:1]/4 |
| Aplastic anemia | 2/3 | 2/4 | 0/0 | 0/0 |
| Other | 1/2b | 1/3c | 0/1d | 0/1d |
| Transplantation history | ||||
| Allogeneic BMT | 5/7 | 6/9 | 2[1:1]/5 | 4[2:2]/12 |
| Unrelated | 4/5 | 5/7 | 1[0:1]/1 | 2[0:2]/4 |
| Related | 1/2 | 1/2 | 1[1:0]/4 | 2[2:0]/8 |
| Matched | 5/6 | 6/8 | 2[1:1]/5 | 4[2:2]/11 |
| Mismatched | 0/1 | 0/1 | 0/0 | 0/1 |
| Solid-organ transplant | 0/0 | 0/0 | 0/0 | 0/0 |
| Pathogen | 0/0e | 2/3f | 9[2:7]/21 | 11[3:8]/32 |
| Aspergillus spp. | 0/0 | 1/1 | 2[1:1]/10 | 4[2:2]/17 |
| Fusarium spp. | 0/0 | 0/0 | 2[0:2]/2 | 2[0:2]/3 |
| Zygomycetes | 0/0 | 0/0 | 1[0:1]/3 | 1[0:1]/3 |
| Chromoblastomycosis | 0/0 | 0/0 | 1[1:0]/1 | 1[1:0]/1 |
| Othersg | 0/0 | 1/2 | 3[0:3]/5 | 3[0:3]/8 |
| Site of infection | 0/0e | 2/3f | 9[2:7]/21 | 11[3:8]/32 |
| Pulmonary | 0/0 | 2/3 | 8[1:7]/20 | 9[2:7]/28 |
| Proven | 0/0 | 0/0 | 2[1:1]/4 | 2[0:2]/8 |
| Probable | 0/0 | 0/0 | 1[0:1]/9 | 2[1:1]/10 |
| Possible | 0/0 | 2/3 | 5[0:5]/7 | 5[1:4]/10 |
| Nonpulmonary | 0/0 | 0/0 | 1[0:1]/1 | 2[1:1]/4 |
| Sinus | 0/0 | 0/0 | 1[0:1]/1 | 1[0:1]/1 |
| Skin | 0/0 | 0/0 | 0/0 | 1[1:0]/1 |
| Blood | 0/0 | 0/0 | 0/0 | 0/1 |
| Oral | 0/0 | 0/0 | 0/0 | 0/1 |
| Neutropenic status | 41/53 | 42/66 | 9[2:7]/21 | 11[3:8]/32 |
| ANC ≤500 cells/μl involvement | 38/49 | 39/60 | 1[0:1]/2 | 2[1:1]/3 |
| ANC >500 cells/μl | 2/3 | 2/3 | 8[2:6]/15 | 9[2:7]/21 |
| Missing | 1/1 | 1/3 | 0/4 | 0/8 |
a
Patients could have had more than one underlying condition.
b
Other underlying diseases were Hodgkin's disease (n = 1) and malignant testis neoplasm (n = 1).
c
Other underlying diseases were Hodgkin's disease (n = 1), malignant testis neoplasm (n = 1), and neoplasm not otherwise specified (n = 1).
d
Other underlying disease was malignant breast neoplasm (n = 1).
e
One efficacy-evaluable patient had nonpulmonary (perianal) Geotrichum infection 3 days after posaconazole discontinuation and was not included in the analysis.
f
Only three all-randomized patients had possible IFI during posaconazole treatment.
g
Other pathogens were not specified.
h
CR, complete response; PR, partial response.