Prospective randomized clinical trial comparing high-dose ifosfamide plus GM-CSF vs high-dose cyclophosphamide plus GM-CSF for blood progenitor cell mobilization

Between August 1993 and June 1999, 56 patients were prospectively randomize d to receive ifosfamide 10 g/m(2) + GM-CSF 5 mu g/kg/day (IFO+GM-CSF n = 28 ) and cyclophosphamide 4 g/m(2) + GM-CSF 5 mu g/kg/day (CY+GM-CSF n = 28). Both groups mere comparable for age, gender, diagnosis, disease stage and p revious chemotherapy. The IFO+GM-CSF group demonstrated a shorter median in terval between therapy and apheresis (10 days (8-14) vs 13 days (8-25) P = 0.002), median number of doses of GM-CSF (9 (7-13) vs 15 (9-31) P = 0.001), median of days with aplasia (0.5 (0-10) vs 6 (0-21) P = 0.001), median day s with fever (0 (0-6) vs 3 (0-9) P = 0.006) and median of days using i.v. a ntibiotics (0 (0-11) vs 7.5 (0-19) P = 0.002). The median MNC yield was sim ilar in both groups. The CD34(+) cell yield was better in the CY+GM-CSF gro up (3.14 (0.9-11.8) vs 5.33 (0.08-32)) but not at significant levels (P = 0 .1). White blood cell hematopoietic recovery was more rapid in the CY+GM-CS F group (16 (10-22) vs 13 (10-24) P = 0.02). Platelet engraftment was simil ar in both groups. Costs of mobilization and transplantation were almost th e same: $28 570 ($18 527-$47 028) and $30 020 ($17 281-$67 591), respective ly (P = 0,9). There were no differences in disease-free survival and overal l survival between both groups. Mild and transient non-hematological toxici ty (hemorrhagic cystitis, decrease in serum creatinine clearance and CNS dy sfunction) was seen most frequently in the IFO+GM-CSF group.