Background
Our previous study demonstrated that in patients affected by acute myeloid leukemia the incidence of invasive aspergillosis (IA) during the course of consolidation chemotherapy is low but that the mortality is not negligible, mainly in older patients. A sub-analysis in the subset of patients ≥60 years demonstrated that patients who didn’t receive mold active prophylaxis had higher incidence of invasive aspergillosis than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with high doses of cytarabine to confirm our data and to identify the subset of patients who require primary anti mold active prophylaxis (PAP).
In light of this, we propose an observational, multicenter, prospective study to evaluate the protective role of mold active PAP in patients ≥60 years underwent to chemotherapy of consolidation with intermediate or high doses of cytarabine.
We will observe two groups of patients: one group that receiving mold active PAP and one group
that don’t receive mold active PAP, in according with the policy of the centers. The drug to be administered for prophylaxis will be chosen at discretion of different centers.
Endpoints
Primary: -To evaluate the incidence of proven, probable and possible IA in patients enrolled in the study in both arms (PAP vs no PAP)
Secondary: – To determine the incidence of “breakthrough infections” in patients underwent to mold active PAP, -To determine the overall mortality and the mortality attributable to IA, -To determine OS of patients in both arms
Sample size
Three hundred patients for arms (90% power to detect a difference of 10%)