A randomized study comparing filgrastim versus lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization

Abstract

We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/ etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or molgramostim at 5 lg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1-3) was performed. The median number of CD34 þ cells obtained after mobilization was 8.4 Â 10 6 /kg in the filgrastim arm versus 5.8 Â 10 6 /kg in the lenograstim arm versus 4.0 Â 10 6 /kg in the molgramostim arm (P ¼ 0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) (Po0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (Po0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34 þ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.

Comparison between filgrastim and lenograstim plus chemotherapy for mobilization of PBPCs

“…Lefre`re et al 35 did not find any difference between glycosylated and non-glycosylated G-CSF in 126 patients with hematological malignancies who underwent PBSC mobilization for auto-SCT. Also, Kopf et al 36 did not find any difference in CD34 þ cell mobilization between patients receiving lenograstim, filgrastim or molgramostim. However, this study prevalently enrolled patients with solid tumors: in fact, it included only 14 NHL, 5 HL and 2 MM patients, of whom 2 HL and 1 NHL failed to mobilize.…”

Granulocyte and erythropoietic stimulating proteins after high-dose chemotherapy for myeloma

“…A randomized study comparing the CD34 þ cell mobilizing efficacy of filgrastim, lenograstim and molgramostim (GM-CSF) showed no statistically significant differences between the three compounds. 42 However, only one study has assessed its use during subsequent high-dose therapy. Legros et al 50 performed a randomized, placebo-controlled trial and showed that the use of GM-CSF had no effect on the time to neutrophil engraftment or on the incidence of documented infections.…”

“…There was a suggestion that GM-CSF may result in more rapid platelet engraftment and reduced severity of mucositis 51,52 but this was not born out in subsequent clinical trials. 42,50 The demonstrated lack of benefit over placebo means that current formulations of GM-CSF are unlikely to be used widely in high-dose therapy programmes.…”

“…Certainly when CSFs are used to mobilize stem cells prior to autologous stem cell transplantation, the weight of evidence suggests there is no significant difference in the potency of filgrastim, lenograstim and the GM-CSF preparation molgramostim. 41,42 Fewer studies have compared these agents as primary prophylaxis during autologous or allogeneic stem cell transplantation. Bonig et al 43 performed the first prospective randomized comparison of filgrastim with lenograstim as primary prophylaxis during chemotherapy in paediatric patients.…”

Sources of Hematopoietic Stem Cells

“…Kopf B et al [62], in 2006 conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and molgramostim (GM-CSF) following a disease-specific chemotherapy regimen. In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.…”