Early (day -7) versus conventional (day -1) inception of cyclosporine-A for graft-versus-host disease prophylaxis after unrelated donor hematopoietic stem cell transplantation in children. Long-term results of an AIEOP prospective, randomized study.
We carried out a randomized, multicenter study comparing the inception of cyclosporine- A (CsA) on day -7 to conventional CsA (on day -1) to evaluate the influence of this modification on graft-versus-host disease (GVHD), treatment-related mortality (TRM), relapse rate (RR), and event-free survival (EFS) in children with hematologic malignancies given unrelated donor (UD) hematopoietic stem cell transplantation (HSCT). Between 1997 and 2002, 152 children transplanted for acute leukemia (102), myelodysplastic syndromes (23), chronic myelogenous leukemia (20), and non-Hodgkin lymphoma (7) were enrolled in the study and randomized to receive either early CsA (group 1, N = 72) or conventional CsA (group 2, N = 80), after stratification according to HLA compatibility and disease phase. The cumulative incidence of both grade II-IV and grade II-IV acute GVHD (aGVHD), as well as of chronic GVHD (cGVHD), did not differ between the 2 groups. No significant differences were observed also with regard to TRM and RR. The 8-year Kaplan-Meier estimates of EFS were 56% in group 1, and 46% in group 2 (P = NS). In the Cox model, advanced disease phase, male recipient, older donor, and occurrence of grade III-IV aGVHD predicted inferior overall EFS. These data indicate that early inception of CsA does not improve posttransplantation outcome of children with hematologic malignancies given UD-HSCT.
Lanino
Edoardo
E
U.O. Ematologia ed Oncologia Pediatrica, Istituto G. Gaslini, Genova, Italy.
Rondelli
Roberto
R
Locatelli
Franco
F
Messina
Chiara
C
Pession
Andrea
A
Balduzzi
Adriana
A
Favre
Claudio
C
Santarone
Stella
S
Rabusin
Marco
M
Pollichieni
Simona
S
Cesaro
Simone
S
Dini
Giorgio
G
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003141:Communicable Diseases / Q000401:mortality; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000401:mortality / Q000517:prevention & control*; D006402:Hematologic Diseases / Q000401:mortality; D019337:Hematologic Neoplasms / Q000601:surgery; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D012008:Recurrence; D014184:Transplantation, Homologous / Q000009:adverse effects
D007166:Immunosuppressive Agents; D016572:Cyclosporine