Voriconazole or itraconazole for antifungal prophylaxis in patients with grade II-IV acute or extensive chronic graft-versus-host disease

Ref ID: 18576

Author:

D. Marks, C. Kibbler, G. Cook, A. Pagliuca, A. Reisman,
P. Miller, M. Kantecki, H. Schlamm on behalf of the IMPROVIT Study Group

Author address:

NULL

Full conference title:

Annual Meeting of the EBMT, 36th

Abstract:

Objective: Antifungal prophylaxis can reduce the incidence of
invasive fungal infections (IFI) in patients with acute or chronic
graft-vs-host disease (GvHD) after allogeneic hematopoietic
cell transplant (alloHCT). We compared outcomes in patients
developing grade II-IV acute or extensive chronic GvHD in a
study comparing oral voriconazole (VOR) to oral itraconazole
suspension (ITR) for primary prophylaxis after alloHCT (the
IMPROVIT study).
Methods: We identifi ed study patients who developed Grade II
or higher acute GvHD or chronic extensive GvHD at any time
during the fi rst 180 days after transplant. We compared baseline patient characteristics, time to fi rst report of GvHD, and
time to discontinuation of study drug in patients receiving VOR S210
vs. ITR as primary prophylaxis. Distributions by treatment of
categorical variables were compared using Fisher’s Exact test,
distributions of time to event (GvHD or duration on study drug)
were compared using Kaplan-Meier estimates. We compared
success of prophylaxis at days 100 and 180 using a composite
endpoint that incorporated ability to tolerate study drug for at
least 86 days, absence of proven or probable invasive fungal
infections and survival to day 180.
Results: 126/489 (25.8%) patients developed grade II-IV
acute GvHD and/or chronic extensive GvHD during the study:
62 received VOR, 64 received ITR. Other than a higher proportion with acute lymphocytic leukemia in the VOR arm
(24.2% vs. 9.4%; P = 0.032), there were no signifi cant differences in baseline characteristics between the 2 study
arms. Mean time to fi rst report of GvHD was 49.6 for VOR
vs. 37.6 days for ITR (P = 0.067). Success of prophylaxis
was 61.3% vs. 43.8% (P = 0.053) at day 100, and 50.0% vs.
29.7% (P = 0.029) at day 180 after alloHCT for VOR and ITR
respectively. Mean duration on study drug was 106.6 vs. 84.4
days (log rank P = 0.009) and proportion completing at least
86 days of study drug was 59.7% vs. 42.2% (P = 0.053) for
VOR and ITR, respectively. Incidence of proven or probable
IFI was low (1.6%) for both study treatments (1 probable pulmonary aspergillosis in each arm); neither IFI was considered treatment-emergent. Survival at day 180 was 80.6% vs.
76.6% (VOR vs. ITR, P = NS).
Conclusion: In patients with grade II-IV acute or chronic extensive GvHD following alloHCT, both VOR and ITR were effective in preventing IFI, but VOR was tolerated for a signifi cantly
longer mean duration.

Abstract Number: P723

Conference Year: 2010

Link to conference website: NULL

New link: NULL

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