ALLOGENEIC BONE-MARROW TRANSPLANTATION VS FILGRASTIM-MOBILIZED PERIPHERAL-BLOOD PROGENITOR-CELL TRANSPLANTATION IN PATIENTS WITH EARLY LEUKEMIA - FIRST RESULTS OF A RANDOMIZED MULTICENTER TRIAL OF THE EUROPEANGROUP FOR BLOOD AND MARROW TRANSPLANTATION

In a multicentre trial involving 20 transplant centres from 10 countri es haematopoietic stem cells mere obtained either from the bone marrow of 33 sibling donors or from the peripheral blood of 33 such donors a fter administration of filgrastim (10 mu g/kg/day). The haematopoietic stem cells were infused into their HLA-identical recipients suffering from acute leukaemias in remission or chronic myeloid leukaemia in ch ronic phase. PBPC donors tolerated filgrastim administration and leuka pheresis well with the most frequent side effects being musculoskeleta l pain, headache, and mild increases of LDH, AP, Gamma-GT or SGPT. Pai n and haematoma at the harvest site and mild anaemia mere the most fre quent complaints of BM donors. Severe or life-threatening complication s were not seen with any type of harvest procedure. Time to platelet r ecovery greater than 20 x 10(9)/I was 15 days (95% confidence interval (CI) 13-16 days) in the PBPCT group and 19 days (CI 16-25) in the BMT group. Time to neutrophil recovery greater than 0.5 x 10(9)/I was 14 days (CI 12-15 days) in the PBPCT group as compared to 15 days (CI 15- 16 days) in the BMT group. The numbers of platelet transfusions admini stered to PBPCT and BMT patients were 12 (range: 1-28) and 10 (range: 3-39), respectively. Sixteen patients (48%) transplanted with bone mar row and 18 patients (54%) transplanted with PBPC developed acute GVHD of grades II-IV; acute GVHD of grades III or IV developed in six (18%) and seven (21%) patients, respectively. Kaplan-Meier plots for transp lant-related mortality until day 100 and leukaemia-free survival at a median of 400 days after BMT or PBPCT showed no significant difference s. Administration of filgrastim and leukapheresis in normal donors wer e feasible and well tolerated. The number of days with restricted acti vity and of nights spent in hospital was lower in donors of PBPC. Tran splantation of PBPC to HLA-identical siblings with early leukaemia res ulted in earlier platelet engraftment. The incidence of moderate to se vere acute GVHD, transplant-related mortality, and leukaemia-free surv ival did not show striking differences. Further investigation of allog eneic PBPCT as a substitute for allogeneic BMT is warranted.