Abstract
We studied the efficacy of two different doses of ganciclovir to prevent cytomegalovirus (CMV) disease in allogeneic hematopoietic stem cell transplantation (HSCT) recipients. We randomly assigned allogeneic HSCT recipients who had CMV infection to receive preemptive ganciclovir therapy with or without induction phase (5 mg/kg twice daily for 1 week). Thirty-two and thirty-six patients were randomized to the standard and the low-dose therapy group, respectively. The median time to CMV antigenemia or viremia clearance was 7 days (3–25 days) in the standard therapy group versus 11 days (3–69 days) in the low-dose therapy group (P = 0.540). The incidence of CMV disease was similar between the two groups (P = 0.366). The Kaplan–Meier estimate of event-free survival by day 180 after HSCT was 76.2% in the standard therapy group versus 66.7% in the low-dose therapy group (P = 0.590). Severe neutropenia (<0.5 × 109/L) was observed in four (12.5%) patients in the standard therapy group versus two (5.6%) patients in the low-dose therapy group (P = 0.314). This study suggests that a low-dose ganciclovir preemptive therapy can be as effective as the standard-dose ganciclovir preemptive therapy for the prevention of CMV disease in allogeneic HSCT recipients.
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References
Meyers JD, Flourney N, Thomas ED. Nonbacterial pneumonia after allogeneic marrow transplantation: a review of ten years’ experience. Rev Infect Dis. 1982;4:1119–32.
Goodrich JM, Mori M, Gleaves CA, Du Mond C, Cays M, Ebeling DF, Buhles WC, DeArrmond B, Meyers JD. Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation. N Engl J Med. 1991;325:1601–7.
Goodrich JM, Bowden RA, Fisher L, Keller C, Schoch G, Meyers JD. Ganciclovir prophylaxis to prevent cytomegalovirus disease after allogeneic marrow transplant. Ann Intern Med. 1993;118:173–8.
Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: a randomized double-blind study. Blood. 1996;88:4063–71.
Salzberger B, Bowden RA, Hackman RC, Davis C, Boeckh M. Neutropenia in allogeneic marrow transplant recipients receiving ganciclovir for prevention of cytomegalovirus disease: risk factors and outcome. Blood. 1997;90:2502–8.
Zaia JA. Prevention of cytomegalovirus disease in hematopoietic stem cell transplantation. Clin Infect Dis. 2002;35:999–1004.
Sommadossi J-P, Carlisle R. Toxicity of 3′-azido-3′-deoxythymidine and 9-(1,3-dihydroxy-2-propoxymethyl)guanine for normal human hematopoietic progenitor cells in vitro. Antimicrob Agent Chemother. 1987;31:452–4.
Mori T, Okamoto S, Watanabe R, Yajima T, Iwao Y, Yamazaki R, Nakazato T, Sato N, Iguchi T, Nagayama H, Takayama N, Hibi T, Ikeda Y. Dose-adjusted preemptive therapy for cytomegalovirus disease based on real-time polymerase chain reaction after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2002;29:777–82.
Vij R, Khoury H, Brown R, Goodnough LT, Devine SM, Blum W, Adkins D, Dipersio JF. Low-dose short-course intravenous ganciclovir as pre-emptive therapy for CMV viremia post allo-PBSC transplantation. Bone Marrow Transplant. 2003;32:703–7.
Reusser P, Einsele H, Lee J, Volin L, Rovira M, Engelhard D, Finke J, Cordonnier C, Link H, Ljungman P. Randomized multicenter trial of foscarnet versus ganciclovir for preemptive therapy of cytomegalovirus infection after allogeneic stem cell transplantation. Blood. 2002;99:1159–64.
Kanda Y, Mineishi S, Saito T, Seo S, Saito A, Ohnishi M, Suenaga K, Niiya H, Nakai K, Takeuchi T, Kawahigashi N, Shoji N, Ogasawara T, Tanosaki R, Kobayashi Y, Tobinai K, Kami M, Mori S, Suzuki R, Kunitoh H, Takaue Y. Preemptive therapy against cytomegalovirus (CMV) disease guided by CMV antigenemia assay after allogeneic hematopoietic stem cell transplantation: a single-center experience in Japan. Bone Marrow Transplant. 2001;27:437–44.
Shigematsu A, Yasumoto A, Yamamoto S, Sugita J, Kondo T, Onozawa M, Kahata K, Endo T, Ota S, Sato N, Takahata M, Okada K, Tanaka J, Hashino S, Nishio M, Koike T, Asaka M, Imamura M. Regimen-related mucosal injury of the gut increased the incidence of CMV disease after allogeneic bone marrow transplantation. Biol Blood Marrow Transplant. 2009;15:679–85.
Weiner RS, Bortin MM, Gale RP, Gluckman E, Kay HE, Kolb HJ, Hartz AJ, Rimm AA. Interstitial pneumonitis after bone marrow transplantation. Assessment of risk factors. Ann Intern Med. 1986;104:168–75.
Boeckh M, Gallez-Hawkins GM, Myerson D, Zaia JA, Bowden RA. Plasma polymerase chain reaction for cytomegalovirus DNA after allogeneic marrow transplantation: comparison with polymerase chain reaction using peripheral blood leukocytes, pp65 antigenemia, and viral culture. Transplantation. 1997;64:108–13.
Acknowledgments
This paper was supported by Konkuk University in 2008. We would like to thank Dr. Sun Woo Kim for statistical assistance and Dr. Nam Yong Lee for performing the CMV assays.
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Kim, S.T., Lee, M.H., Kim, S.Y. et al. A randomized trial of preemptive therapy for prevention of cytomegalovirus disease after allogeneic hematopoietic stem cell transplantation. Int J Hematol 91, 886–891 (2010). https://doi.org/10.1007/s12185-010-0580-2
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DOI: https://doi.org/10.1007/s12185-010-0580-2