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3286 “Low Dose Ganciclovir for Cytomegalovirus Reactivation after Allogeneic HSCT Is a Feasible Option with Same Efficacy and Less Toxicity Than Regular Dose”

Program: Oral and Poster Abstracts
Session: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster III
Hematology Disease Topics & Pathways:
viral, Diseases, Non-Biological, Therapies, Infectious Diseases
Monday, December 7, 2020, 7:00 AM-3:30 PM

Roberta Azevedo1*, Vinicius Campos Molla, MD1,2*, Jessica Fernandes Ramos, MD, PhD1,3*, Danilo Belchior Ponciano1*, Pedro Henrique Arruda De Moraes, MD1,4*, Ana Rita Da Fonseca, MD1,2*, Maria Cristina Nunez Seiwald, MD1,2*, Mariana Serpa, MD1*, Aliana Meneses Ferreira, MD1, Roberta Shcolnik Szor, MD1*, Rayana Bomfim Leonel, MD1,2*, Erick Menezes Xavier, MD1*, Luciana Tucunduva, MD1*, Vanderson Rocha, MD, PhD3,5*, Yana Novis, MD1*, Esper Kallas, MD, PhD1*, Marcio Nucci, MD, PhD6 and Celso Arrais-Rodrigues, MD, PhD1,7

1Hospital Sírio Libanês, São Paulo, Brazil
2Universidade Federal de São Paulo, São Paulo, Brazil
3Universidade de São Paulo, São Paulo, Brazil
4Department of Hematology and Hemotherapy, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil
5Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
6Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil
7Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil

Background: Cytomegalovirus (CMV) reactivation after allogeneic hematopoietic stem cell transplantation (HSCT) occurs in approximately 70% of seropostive patients. CMV reactivation is associated with higher non-relapse mortality (NRM) and worse overall survival (OS). Although preemptive therapy effectively prevents CMV disease, toxicity of ganciclovir (GCV), valganciclovir (VGCV), and foscarnet is a major concern. While GCV 5 mg/kg BID (regular dose) is the most commonly used regimen, some series have suggested that a lower dose (5mg/kg QD, lower dose) could be an option. Objectives: To compare two different regimens of ganciclovir (regular vs. lower dose) for preemptive CMV therapy. Patients and Methods: This was an observational, retrospective study in adult patients who underwent HSCT between April 2007 and April 2020 in two centers. Doses of ganciclovir were determined at the discretion of the transplant physician. The primary endpoint was CMV clearance (rate and time to) between the two preemptive strategies. Results: We analyzed 118 consecutive patients. The median age was 50 years, acute leukemia was the most frequent underlying disease (59%), and most patients received transplants from alternative donors (matched unrelated in 32% and haploidentical in 36%), after reduced-intensity conditioning regimens (76%), with peripheral blood as the source of stem cells (73%). T-cell depletion was performed in 31% (ATG in 29%, alemtuzumab in 2%). In total there were 174 CMV reactivations: 124 (71%) were treated with the regular dose, and 50 (29%) in an outpatient setting with low dose. The median time to CMV clearance was similar between regular and low dose of GCV (15 days vs. 18 days, respectively, p=0.88). The cumulative incidence (CI) of CMV clearance at 30 days was 83% in the regular dose and 88% in the lower dose (p=0.82). By multivariate analysis, correcting for the differences between the groups, the GCV regimen did not influence the time to CMV clearance (hazard ratio 0.94, 95% confidence interval 0.70 – 1.26). On the other hand, hematologic toxicity was more frequent in the regular dose, with more cases of both grade 3-4 neutropenia (59% vs. 33%, respectively, p=0.002) and thrombocytopenia (77% vs. 48%, respectively, p<0.0001). Ten patients had CMV disease and were treated with GCV 5mg/kg BID for 21 days. Conclusion: Our findings suggest that the use of GCV once daily was safe, less toxic, and may be less expensive, considering that most patients will receive the regimen in an outpatient basis. These data should be confirmed in a prospective trial.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH