Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation

Peripheral blood cell (PBC) rescue has become the mainstay for autologous t ransplantation in patients with lymphoma, multiple myeloma, and solid tumor s. Different methods of hematopoietic progenitor cell (HPC) mobilization ar e in use without an established standard. Forty-seven patients with relapse d or refractory lymphoma received salvage chemotherapy and were randomized to have HPC mobilization using filgrastim [granulocyte-colony-stimulating f actor (G-CSF)] alone for 4 days at 10 mug/kg per day (arm A) or cyclophosph amide (5 g/m(2)) and G-CSF at 10 mug/kg per day until hemato-logic recovery (arm B). Engraftment and ease of PBC collection were primary outcomes. All patients underwent the same high-dose chemotherapy followed by reinfusion of PBCs. There were no differences in median time to neutrophil engraftment (11 days in both arms; P = .5) or platelet engraftment (14 days in arm A, 13 days In arm B; P = .35). Combined chemotherapy and G-CSF resulted in hig her CD34(+) cell collection than G-CSF alone (median, 7.2 vs 2.5 x 10(6) ce lls/kg; P = .004), but this did not impact engraftment. No differences were found in other PBC harvest outcomes or resource utilization measures. A hi gh degree of tumor contamination, as studied by consensus CDR3 polymerase c hain reaction of the mobilized PBCs, was present in both arms (92% in arm A vs 90% in arm B; P = 1). No differences were found in overall survival or progression-free survival at a median follow-up of 21 months. This randomiz ed trial provides clinical evidence that the use of G-CSF alone is adequate for HPC mobilization, even in heavily pretreated patients with relapsed ly mphoma. (C) 2001 by The American Society of Hematology.