A Randomized, Controlled Trial of Prophylactic Ganciclovir for Cytomegalovirus Pulmonary Infection in Recipients of Allogeneic Bone Marrow Transplants

Schmidt, G.; Hořák, David; Niland, Joyce C.; Duncan, Steven R.; Forman, Stephen J.; Zaia, John A.

doi:10.1056/nejm199104113241501

Cited by 617 publications

(255 citation statements)

References 25 publications

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“…Prophylaxis and pre-emptive therapy are now used widely in the management of the bone marrow transplant recipient. [12][13][14][15][16][17] In our study all allograft recipients received acyclovir prophylaxis, but the patients were not routinely given pre-emptive ganciclovir therapy. The observation that viral load was significantly higher in patients treated with GCV can be explained by the fact that the majority of patients were given GCV therapy based on clinical assessment of symptoms.…”

Section: Discussionmentioning

confidence: 99%

“…These assays have allowed patient management strategies to be developed so that pre-emptive therapy is now widely used. 12,13 In addition, placebo-controlled trials of ganciclovir (GCV) and acyclovir (ACV), have demonstrated that these drugs can decrease HCMV infection and, in some cases, disease when used prophylactically. [14][15][16][17] Nevertheless, HCMV continues to cause significant disease in bone marrow recipients, necessitating continued routine surveillance for HCMV coupled with specific diagnostic testing in target organs such as lung, liver and gut.…”

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confidence: 99%

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Longitudinal fluctuations in cytomegalovirus load in bone marrow transplant patients: relationship between peak virus load, donor/recipient serostatus, acute GVHD and CMV disease

Gor

Sabin

Prentice

et al. 1998

Bone Marrow Transplant

170

119

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Summary:Quantitative competitive PCR was used to monitor the quantity of cytomegalovirus (HCMV) in 1647 blood samples from 110 BMT recipients. DNAemia was detected in 49/110 (45%) of the patients, of whom 15/49 experienced HCMV disease. Peak virus load during surveillance was elevated in symptomatic (median 4.5 log 10 genomes/ml) vs asymptomatic patients (median 3.6 log 10 genomes/ml, P = 0.002) and was also significantly elevated in HCMV seropositive recipients of seronegative marrow, (R+D−, median 5.0 log 10 ), compared to those in the R−D− and R+D+ groups (P Ͻ 0.01 and Ͻ0.005). Odds ratios for disease per 0.25 log 10 increase in viral load, recipient seropositivity and aGVHD were 1.43 (P = 0.004), 6.60 (P = 0.05) and 3.17 (P = 0.08), respectively. In multivariate logistic regression analysis only elevated viral load remained a significant risk factor for HCMV disease. The computed disease probability viral load curve showed a rapid increase in disease risk at viral loads between 3.8 and 5.5 log 10 genomes/ml in blood, and odds ratios for disease were determined for different threshold viral loads. These data demonstrate the central role of viral load in the pathogenesis of HCMV in BMT recipients and provide an additional marker for targeting and monitoring therapy.

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Longitudinal fluctuations in cytomegalovirus load in bone marrow transplant patients: relationship between peak virus load, donor/recipient serostatus, acute GVHD and CMV disease

Gor

Sabin

Prentice

et al. 1998

Bone Marrow Transplant

170

119

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“…Two patients excreted CMV prior to engraftment and were not included 49. 16 Patients in whom CMV was detected were randomised to receive ganciclovir or to be monitored without treatin the analysis. prevented.…”

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confidence: 99%

“…detected in bronchoalveolar lavage at day 35 significantly Meyers et al 9 showed that aciclovir used alone and reduced the probability of CMV pneumonia from 70% in administered from conditioning until 30 days post-BMT the control group to 10% in the treated group. 16 This has reduced the incidence of CMV disease. In that study, CMV led to the widespread use of pre-emptive therapy with gandisease included CMV pneumonia, and the isolation of ciclovir.…”

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confidence: 99%

“…However, both Goodrich et al 15 and Schmidt et al 16 showed respectively that 12% and 23% of patients who did not excrete CMV nevertheless The effect of prophylaxis on survival is summarised in tice et al, 10 a reduction at 210 days post-transplant was engraftment, 58% of ganciclovir recipients and 28% of placebo recipients experienced neutropenia which required the interruption of the study drug (P = 0.005). Von Bueltzingsloewen 14 also showed that, historically, fewer patients shown among the recipients of long-term prophylactic treatrequired platelet and red blood cell transfusion when ment with high dose i.v.…”

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Clinical strategies for the management of cytomegalovirus infection and disease in allogeneic bone marrow transplant

Kho²

1997

Bone Marrow Transplant

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Summary:agents have been employed in an attempt to prevent the development of CMV infection and disease where either donor or recipient are seropositive. Four clinical strategies are proposed for the management of CMV disease: prophylaxis, suppression, preThere are four therapeutic approaches which can be used. These are: emptive therapy and treatment. The degree of risk of developing CMV disease and the safety profile of the Prophylaxis: Antiviral agents are administered to all BMT presently available drugs need to be considered when deciding on the most appropriate approach. We conrecipients at risk of developing CMV disease. Therapy is started prior to any detection of CMV. clude that a prophylactic strategy employing a drug with a safe toxicity profile followed by pre-emptive Suppression: Antiviral agents are administered to BMT recipients when CMV is detected from peripheral sites such treatment with an effective antiviral drug for failure of prophylaxis gives the best outcome in allogeneic HLA as in the urine or throat washings, but prior to the development of any clinical symptoms of CMV disease. matched bone marrow transplant recipients.

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Allogeneic Hematopoietic Stem Cell Transplantation

Tabbara¹,

Zimmerman²,

Morgan³

et al. 2002

Arch Intern Med

163

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Acute complications such as veno-occlusive disease of the liver, acute and chronic graft-vs-host disease (GVHD), and infectious conditions remain major obstacles for the success of allogeneic hematopoietic stem cell transplantation (HSCT). Progress in allogeneic HSCT depends on several factors, including the adequate prevention and management of associated complications, advances in the conventional management of diseases currently treated with allogeneic HSCT, expansion of the donor pool, selective control of GVHD, development of more effective preparative regimens to eradicate the neoplastic cell population, characterization of a new generation of hematopoietic growth factors and cytokines, and development of newer techniques for ex vivo manipulation of stem cells. Hematopoietic growth factor-mobilized donor progenitor cells collected from peripheral blood have been shown to be associated with rapid hematopoietic engraftment without an increase in the incidence of acute GVHD compared with allogeneic bone marrow transplantation. Implementation of this approach will enhance donor acceptance, eliminate the risk of general anesthesia, decrease cost, and reduce the risk of infectious complications by reducing the duration of neutropenia. Nonmyeloablative allogeneic stem cell transplantation represents a novel treatment approach that may lead to reduced toxic effects and extended use of this treatment in older patients and in those with malignant and nonmalignant disorders. However, GVHD and disease recurrence remain a challenge. Promising results have been reported in patients with refractory hematologic malignancies and in metastatic renal cell cancer. Because late complications are commonly encountered in patients receiving allogeneic HSCT, lifelong observation is needed.

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A Randomized, Controlled Trial of Prophylactic Ganciclovir for Cytomegalovirus Pulmonary Infection in Recipients of Allogeneic Bone Marrow Transplants

Abstract: In recipients of allogeneic bone marrow, asymptomatic CMV infection of the lung is a major risk factor for subsequent CMV interstitial pneumonia. Prophylactic ganciclovir is effective in preventing the development of CMV interstitial pneumonia in patients with asymptomatic infection.

Cited by 617 publications

References 25 publications

Longitudinal fluctuations in cytomegalovirus load in bone marrow transplant patients: relationship between peak virus load, donor/recipient serostatus, acute GVHD and CMV disease

Longitudinal fluctuations in cytomegalovirus load in bone marrow transplant patients: relationship between peak virus load, donor/recipient serostatus, acute GVHD and CMV disease

Clinical strategies for the management of cytomegalovirus infection and disease in allogeneic bone marrow transplant

Allogeneic Hematopoietic Stem Cell Transplantation

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