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

Abstract

Between August 1994 and June 1999, 56 patients were prospectively randomized to receive ifosfamide 10 g/m² + GM-CSF 5 μg/kg/day (IFO+GM-CSF n = 28) and cyclophosphamide 4 g/m² + GM-CSF 5 μg/kg/day (CY+GM-CSF n = 28). Both groups were comparable for age, gender, diagnosis, disease stage and previous chemotherapy. The IFO+GM-CSF group demonstrated a shorter median interval 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 days with fever (0 (0–6) vs 3 (0–9) P = 0.006) and median of days using i.v. antibiotics (0 (0–11) vs 7.5 (0–19) P = 0.002). The median MNC yield was similar in both groups. The CD34⁺ cell yield was better in the CY+GM-CSF group (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-CSF group (16 (10–22) vs13 (10–24) P = 0.02). Platelet engraftment was similar in both groups. Costs of mobilization and transplantation were almost the same: $28 570 ($18 527–$47 028) and $30 020 ($17 281–$67 591), respectively (P = 0.9). There were no differences in disease-free survival and overall survival between both groups. Mild and transient non-hematological toxicity (hemorrhagic cystitis, decrease in serum creatinine clearance and CNS dysfunction) was seen most frequently in the IFO+GM-CSF group. Bone Marrow Transplantation (2000) 25, 1141–1146.