FOSCARNET VS GANCICLOVIR FOR CYTOMEGALOVIRUS (CMV) ANTIGENEMIA AFTER ALLOGENEIC HEMATOPOIETIC STEM-CELL TRANSPLANTATION (HSCT) - A RANDOMIZED STUDY

This trial was designed to compare foscarnet with ganciclovir as pre-e mptive therapy for CMV infection in patients undergoing allogeneic hem opotetic stem cell transplant (HSCT), Thirty-nine patients were random ized to receive foscarnet 90 mg/kg every 12 h (n = 20) Or ganciclovir 5 mg/kg every 12 h (II = 19) for 15 days at the time of development of CMVAg-emia. Primary-end points of the study were (1) outcome of CMVAg -emia; (2) progression to CMV disease; and (3) side-effects of treatme nt. The secondary end-point was transplant-related mortality (TRM), Ta le two groups were comparable for diagnosis, status of disease, donor type, acute graft-versus-host (aGVHD) prophylaxis, interval between HS CT and CMVAg-emia and number of CMVAg positive cells; the donor anti r ecipient age were borderline older in the foscarnet group. Increments of serum creatinine in the foscarnet group, and cytopenia in the ganci clovir group were controlled by reducing the administered dose: in the first 15 days of therapy 9/20 foscarnet and 10/19 ganciclovir patient s had a dose reduction greater than 20% (P=0.43). Clearance of CMVAg-e mia was faster in the foscarnet group although with borderline statist ical significance. Failures of treatment occurred in 3/20 patients in foscarnet group vs 8/19 patients in ganciclovir group (P = 0.06): caus es of failure were the nt:ed for combination therapy to control antige nemia (1/20 vs 5/19), and reactivation during treatment for 2 vs 3 pat ients, respectively. CMV disease was diagnosed in 1.vs 2 patients (P = 0.5) who subsequently died. The actuarial I-year TRM was 25 vs 12%, r espectively (P = 0,3), This study suggests that foscarnet and ganciclo vir are both effective for pre-emptive therapy of CMVAg-emia, although the number of failures would seem to be slightly higher in the gancic lovir patients. Side-effects are seen in both groups and can be manage d with appropriate dose reduction.