A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan. - JSCT-FB10 PB/BM

142 elderly patients (88 men and 54 women; median age, 61 years; range, 55-70 years) were participated, 103 AML and 39 MDS. 21 received related bone marrow (BM) or peripheral blood (PB), 50 did unrelated BM, and 71 did cord blood (CB). 105 (74%) experienced grade III or greater toxicities including 4 SOS. Neutrophil engraftment was achieved in 70 out of 71 related BM/PB or unrelated BM recipients, and 61 of 71 UCB recipients. Cumulative incidences of relapse and non-relapse mortality after 2 years were 24 % and 24.1%, respectively. Overall and event-free survivals at 2 years were 53.3% and 47.4 %, respectively. 2-year OS was 61.5% in related BM/PB, 67.8% in UBM, and 40.8% in CB recipients, showing inferior OS in CB recipients to the other donor types (P<0.05). However, for those in good performance status (ECOG 0) and had low blast count in BM (<5%), the differences became not significant (2-year OS were 77.3% in related BM/PB, 68.4% in UBM, and 65.0% in CB recipients). Conclusion: The myeloablative dose of ivBu was well tolerated without increased toxicity-related mortality. The differences between CB and the others could likely be due to relatively poor conditions of CB recipients. This trial was registered as #UMIN000002426, #UMIN000004213, and #UMIN000004211.