Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation

James M. Goodrich, Motomi Mori, Curt A. Gleaves, Monica Cays, Joel D. Meyers, Charles du Mond, Darlene F. Ebeling, William C. Buhles, Bernadette Dearmond

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510 Scopus citations

Abstract

Background. Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality after allogeneic bone marrow transplantation. We conducted a controlled trial of ganciclovir for the early treatment of CMV infection in asymptomatic recipients of bone marrow transplants whose surveillance cultures for CMV became positive. Methods. Bone marrow—allograft recipients who were seropositive for CMV antibodies or who received seropositive marrow were screened for CMV excretion by culture of throat swabs, blood, urine, or bronchoalveolar-lavage fluid. In this double-blind trial, 72 patients who had marrow engraftment and were excreting virus were randomly assigned to receive either placebo or ganciclovir (5 mg per kilogram of body weight twice a day for one week, followed by 5 mg per kilogram per day) for the first 100 days after transplantation. Patients were followed for the development of biopsy-confirmed CMV disease, ganciclovir-related toxicity, and survival. Results. Between assignment to the study drug and day 100 after transplantation, CMV disease developed in only 1 of the 37 patients assigned to receive ganciclovir (3 percent), but in 15 of the 35 patients assigned to receive placebo (43 percent, P<0.00001). The ganciclovir recipients had rapid suppression of virus excretion; 85 percent had negative cultures after one week of treatment, as compared with 44 percent of the placebo group (P = 0.001). The principal toxic reaction was neutropenia; 11 ganciclovir recipients had an absolute neutrophil count below 0.75 x109 per liter, as compared with 3 placebo recipients (P = 0.052). Treatment was discontinued in 11 ganciclovir recipients and 1 placebo recipient because of neutropenia (P = 0.003). After treatment was stopped, the neutrophil count recovered in all patients. Overall survival was significantly greater in the ganciclovir group than in the placebo group both 100 days and 180 days after transplantation (P = 0.041 and 0.027, respectively). Conclusions. Early treatment with ganciclovir in patients with positive surveillance cultures reduces the ingeneic bone marrow transplantation. (N Engl J Med 1991;325:1601-7.).

Original languageEnglish (US)
Pages (from-to)1601-1607
Number of pages7
JournalNew England Journal of Medicine
Volume325
Issue number23
DOIs
StatePublished - Dec 5 1991

ASJC Scopus subject areas

  • Medicine(all)

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    Goodrich, J. M., Mori, M., Gleaves, C. A., Cays, M., Meyers, J. D., du Mond, C., Ebeling, D. F., Buhles, W. C., & Dearmond, B. (1991). Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation. New England Journal of Medicine, 325(23), 1601-1607. https://doi.org/10.1056/NEJM199112053252303