title: One-year cyclosporine prophylaxis reduces the risk of developing extensive chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplantation.
abstract: OBJECTIVE
  Chronic graft-versus-host disease (GVHD) remains the most common late complication of allogeneic stem cell transplantation, producing significant long-term morbidity and contributing to a substantial risk of late mortality. Chronic GVHD may be more common, more protracted and less responsive to current treatments after peripheral-blood stem cell (PBSC) transplantation than after bone marrow transplantation. The purpose of this retrospective cohort study was to determine whether the hazard of extensive chronic GVHD after allogeneic PBSC transplantation could be decreased by prolonging cyclosporine A (CsA) prophylaxis over 12 months.
  
  
  METHODS
  Fifty-seven consecutive patients with hematologic malignancies who had received a PBSC transplant from an HLA-identical sibling were evaluable for chronic GVHD. All patients began CsA tapering at day 50 but 2 different durations of immunosuppression were used: the first 36 patients were allocated to receive a 6-month course with tapering by 5% at weekly intervals (group A), while the following 21 received a 12-month course with tapering by 5% every 2 weeks (group B).
  
  
  RESULTS
  The cumulative incidence of extensive chronic GVHD at 2 years was 69% (95% CI, 53-85%) for group A and 25% (95% CI, 3-47%) for group B with a significantly lower hazard in group B than in group A (HR=0.2; 95% CI, 0.07-0.57; p=0.0009). In multivariate analysis, the 12-month CsA tapering schedule was associated with a significantly decreased risk of extensive chronic GVHD (HR=0.2; 95% CI, 0.06-0.66; p=0.008). The hazard of transplant-related mortality, relapse and failure to survive in remission was not significantly different among the 2 groups.
  
  
  CONCLUSIONS
  One-year CsA prophylaxis seems to be more effective than the standard six-month CsA regimen at preventing extensive chronic GVHD after PBSC transplant from an HLA-identical sibling. Conclusive assessment of the benefits of such prolonged immunosuppression, in terms of better quality of life and minor morbidity, requires both long-term follow-up to evaluate the rates of relapse and secondary tumors and a randomized setting.
authors.affiliation: Department of Cell Biotechnology and Hematology, University La Sapienza, via Benevento, 00161 Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Mengarelli
authors.forename: Anna Paola
authors.initials: AP
authors.lastname: Iori
authors.forename: Atelda
authors.initials: A
authors.lastname: Romano
authors.forename: Raffaella
authors.initials: R
authors.lastname: Cerretti
authors.forename: Lorenza
authors.initials: L
authors.lastname: Cerilli
authors.forename: Maria Stefania
authors.initials: MS
authors.lastname: De Propris
authors.forename: Susanna
authors.initials: S
authors.lastname: Fenu
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Moleti
authors.forename: Lidia
authors.initials: L
authors.lastname: De Felice
authors.forename: Gabriella
authors.initials: G
authors.lastname: Girelli
authors.forename: William
authors.initials: W
authors.lastname: Arcese
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002908:Chronic Disease; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000517:prevention & control*; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D012306:Risk; D012307:Risk Factors; D014184:Transplantation, Homologous / Q000379:methods
chemical_list: D016572:Cyclosporine