Clinical experience with a simple algorithm for plerixafor utilization in autologous stem cell mobilization

Chen, A I; Bains, Tarunpreet; Murray, S.; Knight, R.K.; Shoop, Kelsea M.; Bubalo, Joseph; Fowler, Cynthia; Slater, Susan; Maziarz, Richard T.

doi:10.1038/bmt.2012.74

Cited by 33 publications

(28 citation statements)

References 11 publications

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“…Similar approaches to algorithm management at single centers have been recently reported. 10,15,16 Individual centers may need to consider variables in how stem cells are mobilized and collected that are unique to their institutions. Larger prospective studies are needed to confirm if the increased cost associated with the use of plerixafor is offset by decreased apheresis costs.…”

Section: Discussionmentioning

confidence: 99%

Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin’s lymphoma and multiple myeloma: results from the expanded access program

Shaughnessy

Uberti

Devine

et al. 2012

Bone Marrow Transplant

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Before US regulatory approval, an expanded access program provided plerixafor to patients with non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma (MM) who had not previously failed mobilization and were otherwise candidates for auto-SCT. Patients received granulocyte-CSF (G-CSF) 10 mcg/kg daily and plerixafor 0.24 mg/kg starting on day 4 with apheresis on day 5; all repeated daily until collection was complete. Overall, 104 patients received X1 dose of plerixafor. The addition of plerixafor to G-CSF resulted in a median threefold increase in peripheral blood CD34 þ cell count between days 4 and 5. Among 43 NHL patients, 74% met the target of X5 Â 10 6 CD34 þ cells/kg (median, 1 day apheresis, range 1-5 days); among 7 HD patients, 57% met the target of X5 Â 10 6 CD34 þ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of X6 Â 10 6 CD34 þ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had X2 Â 10 6 CD34 þ cells/kg collected within 1-3 days. Plerixafor-related toxicities were minimal. Engraftment kinetics, graft durability and transplant outcomes demonstrated no unexpected outcomes. Efficacy and safety results were similar to results in phase II and III clinical trials.

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Section: Discussionmentioning

confidence: 99%

Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin’s lymphoma and multiple myeloma: results from the expanded access program

Shaughnessy

Uberti

Devine

et al. 2012

Bone Marrow Transplant

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“…Different strategies have been developed to optimize the use of plerixafor . As PBCD34 correlates with apheresis product CD34 + cell count in multiple studies , we and others have utilized a PBCD34 count threshold for early identification of patients at high risk of collection failure .…”

Section: Discussionmentioning

confidence: 99%

An algorithm for utilizing peripheral blood CD34 count as a predictor of the need for plerixafor in autologous stem cell mobilization—cost‐effectiveness analysis

Abusin

Abu‐Arja

Gingrich

et al. 2013

J of Clinical Apheresis

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Certain patients who receive granulocyte colony-stimulating factor (GCSF) for autologous hematopoietic stem cell (AHSC) collection fail to mobilize well enough to proceed with transplant. When plerixafor is used with GCSF, the likelihood of achieving the CD34⁺ stem cell target in fewer collections is higher; plerixafor use in all patients is unlikely to be cost-effective. This study retrospectively evaluated the effectiveness of utilizing a peripheral blood CD34⁺ stem cell count (PBCD34) ≤8/µL on day 4 of GCSF-based AHSC mobilization as a threshold for plerixafor administration, and compared the efficacy of collection and cost analysis using historical controls. All patients in the study cohort reached their CD34⁺ targets in ≤3 collections. Significantly more patients who received plerixafor + GCSF versus GCSF alone reached their CD34⁺ target in one collection (P = 0.045); however, there were no significant differences in the number of collections or in cumulative product yields. The historical cohort had 10.3% mobilization failures; the number of collections per patient needed to reach the target was significantly higher in the historical cohort versus study cohort (P = 0.001) as was the number of patients requiring more than one collection to reach their target (P = 0.023). However, the average cost per patient was also significantly higher in the study cohort (P = 0.025). Further refinement of the algorithm may reduce the difference in cost between the two mobilization strategies.

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“…Analysis of the literature regarding cut-off values for CD34z cell counts after at least 4 days of treatment with G-CSF indicates that cut-off values for pre-plerixafor CD34z cell counts implemented in some centres in US and EU and defining a group of 'proven poor mobilizers' are close to those used in the Belgian reimbursement criteria. 8,[24][25][26][27][28][29] In addition to decision making based on pre-apheresis CD34z cell counts, in many centres 'known poor mobilizers' (patients with previous mobilization failure, i.e. a collection yield of less than 2610 6 cells/kg) are treated with plerixafor.…”

Section: Discussionmentioning

confidence: 99%

Plerixafor prescription modalities in autologous haematopoietic stem cell mobilization in Belgium

Selleslag

Lambert

Zachée

et al. 2014

Acta Clinica Belgica

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Objectives: The efficacy and safety of plerixafor, an antagonist of the CXCR4 receptor, in combination with G-CSF has been demonstrated in patients suffering from Iymphoma and multiple myeloma (MM) eligible for autologous haematopoietic stem cell collection. However, different reimbursement criteria have been applied in different countries to select patients eligible for treatment with plerixafor. The objective of this observational study was to describe the plerixafor prescription modalities in daily practice in Belgium. Methods: This open-label, prospective, observational study was conducted in 11 Belgian centres in 114 patients with lymphoma (Hodgkin's and non-Hodgkin's lymphoma) or MM who were treated with plerixafor according to the SmPC between April 2011 and October 2012. Patients included in another clinical trial with plerixafor were excluded from the study. Results: The use of plerixafor in patients with MM or lymphoma was effective, with a success rate (defined as a total yield > 2 x 10(6) CD34+ cells/kg) of 77%, and well tolerated (one SAE reported). Optimal collection (defined as a total yield >4 x 10(6) CD34+ cells/kg) was obtained for 43% of the study population (31% in lymphoma patients, compared to 61% in patients with MM). The use of plerixafor was in line with the SmPC and the Belgian reimbursement criteria for all patients. Conclusion: This study is showing that the use of plerixafor according to Belgian reimbursement criteria results in similar efficacy and safety as in other centres and countries worldwide

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Clinical experience with a simple algorithm for plerixafor utilization in autologous stem cell mobilization

Cited by 33 publications

References 11 publications

Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin’s lymphoma and multiple myeloma: results from the expanded access program

Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin’s lymphoma and multiple myeloma: results from the expanded access program

An algorithm for utilizing peripheral blood CD34 count as a predictor of the need for plerixafor in autologous stem cell mobilization—cost‐effectiveness analysis

Plerixafor prescription modalities in autologous haematopoietic stem cell mobilization in Belgium

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