Liposomal amphotericin B prophylaxis of invasive mold infections in children post allogeneic stem cell transplantation.
BACKGROUND
Invasive mold infections (IMI) are a leading cause of infectious mortality in allogeneic stem cell transplant (AlloSCT) recipients. Fluconazole, the current standard for fungal prophylaxis, is ineffective against molds. We initiated a pilot study to determine the safety and activity of prophylactic liposomal amphotericin B (AMB) in preventing IMI in pediatric and adolescent AlloSCT recipients during the first 100 days.


METHODS
Fifty-one patients (57 AlloSCT) were given AMB (3 mg/kg/day) intravenously, day 0-100. Median age 6 years, 32 males, 19 females. Donors: 33 unrelated and 2 related cord blood, 13 related and 1 unrelated peripheral blood stem cell and 8 related bone marrow (BM); 30 received myeloablative and 27 reduced intensity conditioning. Graft-versus-host disease (GVHD) prophylaxis comprised tacrolimus and mycophenolate mofetil.


RESULTS
Median follow-up is 557 days. AMB was generally well tolerated. The probability of developing >/=grade II acute GVHD and extensive chronic GVHD was 45% and 7%, respectively. Estimated 1-year OS is 62.4% for all patients with 78.8% and 26.7% for average-risk and poor-risk, respectively. The incidence of IMI was 0%.


CONCLUSIONS
These results suggest prophylactic AMB is tolerable and may prevent IMI, especially Aspergillus, during the first 100 days post AlloSCT in pediatric and adolescent patients. A randomized study is needed to determine the efficacy of this approach.
Roman
Elizabeth
E
Department of Pediatrics, Columbia University, New York, New York, USA.
Osunkwo
Ifeyinwa
I
Militano
Olga
O
Cooney
Erin
E
van de Ven
Carmella
C
Cairo
Mitchell S
MS
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000009:adverse effects / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006402:Hematologic Diseases / Q000382:microbiology / Q000628:therapy; D006801:Humans; D007223:Infant; D008297:Male; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*; D033581:Stem Cell Transplantation / Q000379:methods*
D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B