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Blood, 15 February 2002, Vol. 99, No. 4, pp. 1159-1164
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Randomized multicenter trial of foscarnet versus
ganciclovir for preemptive therapy of cytomegalovirus infection after
allogeneic stem cell transplantation
Pierre Reusser,
Hermann Einsele,
John Lee,
Liisa Volin,
Montserrat Rovira,
Dan Engelhard,
Jürgen Finke,
Catherine Cordonnier,
Hartmut Link, and
Per Ljungman for the Infectious Diseases Working Party of the European
Group for Blood and Marrow Transplantation
From the Medizinische Klinik A, University Hospital,
Basel, Switzerland; Medizinische Klinik, University Hospital,
Tübingen, the Division of Hematology, University Hospital,
Freiburg, and the Medizinische Klinik I, Westpfalz Klinikum,
Kaiserslautern, Germany; Astra Arcus AB, Södertälje, and
the Department of Hematology, Huddinge University Hospital, Stockholm,
Sweden; Department of Medicine, Helsinki University Central Hospital,
Finland; BMT unit, Department of Hematology, Hospital Clinic,
Barcelona, Spain; Department of Pediatrics and Bone Marrow
Transplantation, Hadassah University Hospital, Jerusalem, Israel; and
the Service d'Hématologie, Hôpital Henri Mondor,
Créteil, France. A complete list of the members of the Infectious
Diseases Working Party of the European Group for Blood and Marrow
Transplantation is given in the appendix at the end of this article.
The present study compared foscarnet with ganciclovir for
preemptive therapy of cytomegalovirus (CMV) infection after allogeneic blood or marrow stem cell transplantation (SCT). Patients with CMV
infection, as detected by weekly antigenemia or polymerase chain
reaction (PCR) in blood leukocytes, were randomized to intravenous therapy for 2 weeks with either foscarnet at 60 mg/kg or ganciclovir at
5 mg/kg administered every 12 hours; if CMV infection remained detectable, patients received an additional 2 weeks of intravenous foscarnet at 90 mg/kg or ganciclovir at 6 mg/kg given once daily for 5 days per week, after which therapy was stopped. Primary efficacy
endpoint was the occurrence of CMV disease or death from any cause
within 180 days after SCT. A total of 213 patients were treated with
either foscarnet (n = 110) or ganciclovir (n = 103). Kaplan-Meier
estimates of event-free survival within 180 days after SCT were similar
in the 2 treatment groups (P = .6). During study
treatment, severe neutropenia (< 0.5 × 109/L) occurred
in 11 (11%) patients on ganciclovir versus 4 (4%) patients on
foscarnet (P = .04), and impaired renal function was observed in 5 (5%) patients on foscarnet versus 2 (2%) patients on
ganciclovir (P = .4). Neutropenia or thrombocytopenia
required discontinuation of ganciclovir in 6 (6%) patients but in no
foscarnet-treated patient (P = .03). After allogeneic
SCT, preemptive therapy of CMV infection with foscarnet shows similar
efficacy as with ganciclovir, but is associated with a lower proportion
of patients who develop severe neutropenia and who require
discontinuation of antiviral therapy due to hematotoxicity.
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