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Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir
versus ganciclovir at engraftment after allogeneic marrow transplantation:
a randomized double-blind study
M Boeckh, TA Gooley, D Myerson, T Cunningham, G Schoch and RA Bowden
Fred Hutchinson Cancer Research Center, Program in Infectious Diseases,
Seattle, WA 98104, USA.
To determine whether cytomegalovirus (CMV) antigenemiaguided ganciclovir
treatment may be as effective, may require less treatment, and thus may
cause less marrow toxicity than ganciclovir administered at engraftment,
226 marrow transplant recipients were randomized at engraftment to receive
placebo (antigenemia-ganciclovir group) or ganciclovir (ganciclovir group)
until day 100 in a double-blind study. In patients with antigenemia of 3 or
more positive cells in 2 slides and/or viremia, study drug was discontinued
and ganciclovir was started for at least 3 weeks or until negative CMV
antigenemia and resumed only if antigenemia recurred. More patients in the
antigenemia-ganciclovir group developed CMV disease before day 100 after
transplantation compared with the ganciclovir group (14% v 2.7%, P = .002).
Of the 16 patients with CMV disease before day 100 in the
antigenemia-ganciclovir group, 10 (8.8%) had disease before or during the
first episode of antigenemia and 6 (5.3%) developed disease after
discontinuation of ganciclovir. Untreated low-grade antigenemia progressed
to CMV disease in 19% of patients with grade 3-4 compared with 0% of
patients with grade 0-2 acute graft-versus-host disease (P = .04). There
was no significant difference in CMV disease by day 180 after
transplantation and thereafter. CMV-related death, transplant survival, and
neutropenia were not significantly different between the groups. In the
ganciclovir group, more invasive fungal infections occurred (P = .03) and
more ganciclovir was used (P < .0001). Thus, delaying the start of
ganciclovir until highgrade antigenemia and discontinuing ganciclovir based
on negative antigenemia results in more CMV disease by day 100 than
ganciclovir administered at engraftment. However, ganciclovir at
engraftment is associated with more early invasive fungal infections and
more late CMV disease resulting in similar survival rates.
Volume 88,
Issue 10,
pp. 4063-4071,
11/15/1996
Copyright © 1996 by The American Society of Hematology
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