Plerixafor on‐demand combined with chemotherapy and granulocyte colony‐stimulating factor: significant improvement in peripheral blood stem cells mobilization and harvest with no increase in costs

Abstract

SummaryTo date, no prospective study on Plerixafor 'on-demand' in combination with chemotherapy and granulocyte colony-stimulating factor (G-CSF) has been reported. We present an interim analysis of the first prospective study in which Plerixafor was administered on-demand in patients affected by multiple myeloma and lymphoma who received high dose cyclophosphamide or DHAP (dexamethasone, cytarabine, cisplatin) plus G-CSF to mobilize peripheral blood stem cells (PBSC). One hundred and two patients were evaluable for response. A cohort of 240 patients receiving the same mobilizing chemotherapy was retrospectively studied. Failure to mobilize CD34 + cells in peripheral blood was reduced by 'on-demand' strategy compared to conventional mobilization; from 13Á0 to 3Á0% (P = 0Á004). Failure to harvest CD34 + cells 2 9 10 6 /kg decreased from 20Á9 to 4Á0% (P = 0Á0001). The on-demand Plerixafor strategy also resulted in a lower rate of mobilization failure (P = 0Á03) and harvest failure (P = 0Á0008) when compared to a 'bias-adjusted set of controls'. Evaluation of economic costs of the two strategies showed that the overall cost of the two treatments were comparable when salvage mobilizations were taken into account. When in combination with cyclophosphamide or DHAP plus G-CSF, the 'on-demand' use of Plerixafor showed, in comparison to conventionally treated patients, a significant improvement in mobilization of PBSC with no increase in overall cost.

Plerixafor for Autologous Stem-Cell Mobilization and Transplantation for Patients in Ontario

“…Similarly, four nonrandomized trials using historical controls 8,9,11,12 reported a statistically significant increase in the proportion of patients collecting CD34+ cells in favour of mobilization therapies using plerixafor compared with conventional treatment (68% -94% vs. 15%-76% respectively). The two rcts reported by DiPersio et al 6,7 are the current best evidence from research concerning the safety and efficacy of plerixafor for autologous stem-cell mobilization and transplantation, given that rcts are the most rigorous way of determining evidence of cause and effect.…”

“…Twenty-two studies assessing the efficacy and safety of plerixafor for autologous stem-cell mobilization and transplantation were retained: two randomized controlled trials (rcts) 6,7 , five nonrandomized controlled trials [8][9][10][11][12] , three retrospective cohort studies with a contemporaneous control arm [13][14][15] , and twelve single-arm studies [16][17][18][19][20][21][22][23][24][25][26][27] .…”

“…The five nonrandomized controlled trials [8][9][10][11][12] included fully described the inclusion and exclusion criteria, mobilization protocol, and outcomes of interest. Four of the studies compared outcomes with matched historical controls mobilized using a therapy that did not include plerixafor 8,9,11,12 .…”

“…Four of the studies compared outcomes with matched historical controls mobilized using a therapy that did not include plerixafor 8,9,11,12 .…”

“…Apheresis Procedures: One rct reported by DiPersio et al 7 and two trials with historical controls demonstrated the ability of regimens with plerixafor, compared with conventional mobilization therapies, to significantly reduce the number of apheresis procedures required to collect the target number of CD34+ cells (1 vs. 4, p < 0.001) 7 , (1.61 vs. 1.43, p = 0.04) 11 , and (3 vs. 2, p < 0.0001) 14 . Two trials with historical controls reported no differences between groups with respect to the time of collection 9,12 .…”