Journal of Clinical Oncology, Vol 15, 2269-2274, Copyright © 1997 by American Society of Clinical Oncology
Acyclovir prophylaxis and fever during remission-induction therapy of patients with acute myeloid leukemia: a randomized, double-blind, placebo-controlled trial
OJ Bergmann, SC Mogensen, S Ellermann-Eriksen and J Ellegaard
Department of Medicine and Hematology, Aarhus University Hospital, Denmark.
PURPOSE: A randomized, double-blind, placebo-controlled trial was performed
to estimate the preventive effect of the antiherpetic drug acyclovir on
fever, incidence of bacteremia, use of antibiotics, and presentation of
infections in patients with acute myeloid leukemia (AML). PATIENTS AND
METHODS: Ninety herpes simplex virus (HSV)- seropositive patients aged 18
to 84 years were included. Forty-five patients received acyclovir (800 mg
by mouth daily) and 45 placebo. The patients were examined daily for 28
days from the initiation of remission-induction chemotherapy. RESULTS:
Fever developed in all patients in both groups. Acyclovir prophylaxis
postponed the development of an oral temperature > or = 38.0 degrees C
by 3 days (95% confidence interval [CI], 1 to 4 days; P = .03) and the
initiation of antibacterial treatment by 3 days (95% CI, 1 to 5 days; P =
.008). The duration of fever, use of antibacterial treatment, incidence of
bacteremia, and need for systemic antifungal therapy were not affected by
acyclovir prophylaxis. At fever development, acyclovir prophylaxis affected
the incidence and localization pattern of oral ulcers. Thus, in the
acyclovir group, the number of nonfungal oral infections was reduced
(relative risk, 0.45 [95% CI, 0.24 to 0.85]) and mainly located on the soft
palate (relative risk, 2.49 [95% CI, 1.19 to 5.22]). CONCLUSION: Acyclovir
prophylaxis has an impact on fever development, but not on the duration of
fever or the need for antibiotics. It does not reduce the incidence of
bacteremia, but the presentation of acute oral infections is changed.
