A randomized comparison of cyclophosphamide vs. reduced dose cyclophosphamide plus fludarabine for allogeneic hematopoietic cell transplantation in patients with aplastic anemia and hypoplastic myelodysplastic syndrome
Annals of Hematology,
Kim H et al. – The 4–year survival rate did not differ between the Cy–ATG and cyclophosphamide (Cy), fludarabine, and anti–thymocyte globulin (ATG) (Cy–Flu–ATG) arms. Preconditioning with Cy–Flu–ATG was superior to that afforded by Cy–ATG in terms of reducing regimen–related toxicities (RRTs) levels without increasing engraftment failure.Methods
- The authors performed a randomized phase III study to compare the regimen-related toxicities (RRTs) of two different conditioning regimens: Cy-ATG vs. Cy-Flu-ATG.
- Patients in the Cy-ATG arm received Cy at 200mg/kg.
- Those in the Cy-Flu-ATG arm received fludarabine (Flu) at 150mg/m2 and Cy at 100mg/kg.
- A total of 83 patients (40 in the Cy-ATG and 43 in the Cy-Flu-ATG) were enrolled.
- Seventy-nine patients had AA and four had MDS.
- All predefined RRTs were significantly lower in patients of the Cy-Flu-ATG arm (23.3 vs. 55.0 %; p=0.003).
- Infection with identified causative organism and sinusoidal obstruction syndrome, hematuria, febrile episodes, and death from any cause tended to be more frequent in Cy-ATG arm but did not differ significantly between arms.
- There was no difference in neutrophil engraftment failure (2.5 vs. 2.33 %; p=0.959), acute graft-versus-host disease (GvHD) (15.0 vs. 23.3 %; p=0.388), and chronic GvHD (16.7 vs. 16.2 %; p=0.961) between Cy-ATG and Cy-Flu-ATG arms.
- The 4-year survival rate did not differ between the Cy-ATG and Cy-Flu-ATG arms.