UK consensus statement on the use of plerixafor to facilitate autologous peripheral blood stem cell collection to support high‐dose chemoradiotherapy for patients with malignancy

Douglas, Kenneth; Gilleece, Maria; Hayden, Patrick; Hunter, Hannah; Johnson, Peter; Kallmeyer, Charlotte; Malladi, Ram; Paneesha, Shankara; Pawson, Rachel; Quinn, Michael; Raj, Kavita; Richardson, Deborah; Robinson, Stephen; Russell, Nigel H.; Snowden, John A.; Sureda, Anna; Tholouli, Eleni; Thomson, Kirsty; Watts, Mike; Wilson, Keith

doi:10.1002/jca.21563

Cited by 41 publications

(40 citation statements)

References 40 publications

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“…Protocol 3 allowed us to obtain a significantly greater number of CD34+ cells than the other protocols: 7.93 × 10 6 CD34+ cells/kg vs 5.3 × 10 6 CD34+ cells/kg (protocol 1) and 4.28 × 10 6 CD34+ cells/kg (protocol 2). In other studies, this fact has also been suggested, either with the introduction of plerixafor [22][23][24][25][26] or with LVL. 2 In our country (Spain), there are no cost-benefit studies of mobilization protocols.…”

Section: Discussionmentioning

confidence: 97%

Comparison and cost analysis of three protocols for mobilization and apheresis of haematopoietic progenitor cells

Castaño

Manresa

Díaz

et al. 2019

J of Clinical Apheresis

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Introduction Autologous bone marrow transplantation is a component of the malignant hemopathy therapy. The preferred mobilization and collection method is apheresis. The aim of this study is to compare three protocols analyzing the effect of plerixafor, higher dose of G‐CSF and large volume leukapheresis (LVL). Materials and methods A retrospective cohort study including 119 patients referred for mobilization. Three protocols were compared: (a) G‐CSF 10 μg/kg/day subcutaneous (sc) × 4 days mobilizing 1 to 1.5 blood volumes. (b) G‐CSF 10 μg/kg/day sc × 4 days + plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 1 to 1.5 blood volumes. (c) G‐CSF 20 μg/kg/day sc × 4 days ± plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 3 to 4 blood volumes. Results The average number of days of apheresis was reduced to 1.37 with protocol 3. The average cost per patient was reduced by 67% compared with protocol 2 and increased by only 5% compared with protocol 1, reducing the failure rate to 0%. Conclusion Adding preemptive or rescue plerixafor (protocol 2) to G‐CSF 10 μg/kg/day alone (protocol 1) did not improve the days of apheresis nor the number of CD34+ cells collected but had higher cost and failure rate. Using LVL, plerixafor and G‐CSF 20 μg/kg/day (protocol 3) decreased the number of sessions to 1.37, reduced the failure rate to 0% and led to a significant increase in the number of CD34+ cells collected without toxicity and with a similar cost to protocol 1.

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Section: Discussionmentioning

confidence: 97%

Comparison and cost analysis of three protocols for mobilization and apheresis of haematopoietic progenitor cells

Castaño

Manresa

Díaz

et al. 2019

J of Clinical Apheresis

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“…Plerixafor is expensive and was used in selected cases. The administration of plerixafor is reported to be safe and efficacious in pediatric patients with a solid tumor, with mild adverse effects involving gut and injection site 34‐36 …”

Section: Discussionmentioning

confidence: 99%

Autologous stem cell transplant for high‐risk neuroblastoma: Achieving cure with low‐cost adaptations

Jain¹,

Hans

Totadri³

et al. 2020

Pediatric Blood & Cancer

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Background:The majority of patients in low-and middle-income countries (LMIC) are unable to receive optimal therapy, including autologous stem cell transplant (ASCT) for high-risk neuroblastoma. Management is intensive and multidisciplinary; survival is often poor. We report a singlecenter outcome of high-risk neuroblastoma, with adaptations optimized for LMIC. Procedure:The study was retrospective. Patients were treated on the backbone of the highrisk neuroblastoma study-1 of SIOP-Europe (HR-NBL1/SIOPEN) protocol with ASCT. Adaptations incorporated to decrease cost, requirement for inpatient admission, infections, and faster engraftment included (a) optional outpatient administration for rapid-COJEC, (b) two sessions of stemcell apheresis, (c) storing stem cells at 2-6 • C without cryopreservation for up to 7 days, (d) no central lines, (e) no antibacterial/antifungal/antiviral prophylaxis, (f) omitting formal assessment of cardiac/renal/pulmonary functions before ASCT, and (g) administration of pegylated granulocyte colony-stimulating factor on Day +4.Results: Over 5 years 9 months, 35 patients with high-risk neuroblastoma were treated. Rapid-COJEC was administered over a median duration of 80 days (interquartile range: 77, 83). Conditioning regimen included melphalan (n = 7), oral busulfan-melphalan (Bu/Mel; n = 6), or intravenous Bu/Mel (n = 22). The median viability of stem cells stored for 6 days (n = 28) was 93% (range: 88-99). Two (5.7%) patients had ASCT-related mortality. The 3-year overall and event-free

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“…However, all previous studies were done with healthy people. When considering the use of plerixafor in patients, based on the efficacy of plerixafor in two blinded randomized Phase III placebo‐controlled studies in patients with multiple myeloma and non‐Hodgkin lymphoma, current recommendations about this topic state that patients in a preemptive use protocol should receive a dose of plerixafor (0.24 mg/kg) after 4 to 5 days receiving G‐CSF (5‐10 μg/kg/day) and patients should start leukocytapheresis 10 to 12 hours after plerixafor administration . In real life, it means to administer plerixafor at 10:00 PM to capture the peak mobilizing effect 10 hours later, at 8:00 AM.…”

Section: Discussionmentioning

confidence: 99%

“…When considering the use of plerixafor in patients, based on the efficacy of plerixafor in two blinded randomized Phase III placebo-controlled studies in patients with multiple myeloma and non-Hodgkin lymphoma, 6,7 current recommendations about this topic state that patients in a preemptive use protocol should receive a dose of plerixafor (0.24 mg/kg) after 4 to 5 days receiving G-CSF (5-10 μg/kg/ day) and patients should start leukocytapheresis 10 to 12 hours after plerixafor administration. 4,5,[23][24][25] In real life, it means to administer plerixafor at 10:00 PM to capture the peak mobilizing effect 10 hours later, at 8:00 AM. Because of this inconvenient timing, other authors administered plerixafor at 5:00 PM 11,26 or at 3:00 PM 12 and started leukocytapheresis the next day at 8:00 AM 11,12 or at 10:00 to 11:00 AM, 26 which means a delay of 15, 17, or up to 18 hours, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Plerixafor (Mozobil, Sanofi) added to G‐CSF has been increasingly used as a procedure to overcome mobilization failure. It has been incorporated as a mobilization strategy in three different ways: “delayed remobilization,” “preemptive use,” and “up front.” Preemptive use, also known as “rescue” or “just‐in‐time use,” means the introduction of plerixafor in the course of a mobilization episode to improve the collection of HPCs, and it is usually guided by the number of CD34+ cells circulating in peripheral blood before starting leukocytapheresis . According to the manufacturerʼs instructions, based on results obtained in the two Phase III studies, plerixafor should be administered 6 to 11 hours before starting leukocytapheresis .…”

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Increased collection efficiency of CD34+ cells after mobilization with preemptive use of plerixafor followed by leukocytapheresis on the same day

et al. 2020

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BACKGROUND Plerixafor should be administered 6 to 11 hours before starting leukocytapheresis. However, we have been using plerixafor followed by leukocytapheresis according to different time schedules since 2007. Our objective was to compare the CD34+ cell collection efficiency (CE1) of the first leukocytapheresis performed after using plerixafor at different time intervals. STUDY DESIGN AND METHODS Same‐day schedule refers to the administration of plerixafor at 10:00 AM and starting the leukocytapheresis on the same day at 4:00 PM (6 hours interval). Next‐day schedule refers to the administration of plerixafor at 8:00 PM and starting the leukocytapheresis on the next day (10:00 AM or 4:00 PM; either a 14‐ or 20‐hr interval). Variables that might influence the CE1 of CD34+ cells were analyzed by longitudinal linear regression with a random effects model derived by generalized estimating equations. RESULTS The median CE1 of CD34+ cells was higher in the group of 30 patients who underwent leukocytapheresis on the same day when compared with the group of 62 patients who underwent leukocytapheresis on the next day (65.8% vs. 56.7%; p < 0.01). In the longitudinal linear regression analysis, only the time from plerixafor administration to leukocytapheresis start was associated with a statistically significant decrease in the CE1 of CD34+ cells (CE1 change −0.034%; p < 0.01). CONCLUSION Higher CE1 of CD34+ cells was observed when patients underwent leukocytapheresis on the same day after receiving plerixafor in comparison with administering plerixafor and underwent leukocytapheresis on the next day. Larger studies are necessary to confirm present results.

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UK consensus statement on the use of plerixafor to facilitate autologous peripheral blood stem cell collection to support high‐dose chemoradiotherapy for patients with malignancy

Abstract: Plerixafor is a CXC chemokine receptor (CXCR4) antagonist that mobilizes stem cells in the peripheral blood. It is indicated (in combination with granulocyte-colony stimulating factor [G-CSF]

Cited by 41 publications

References 40 publications

Comparison and cost analysis of three protocols for mobilization and apheresis of haematopoietic progenitor cells

Comparison and cost analysis of three protocols for mobilization and apheresis of haematopoietic progenitor cells

Autologous stem cell transplant for high‐risk neuroblastoma: Achieving cure with low‐cost adaptations

Increased collection efficiency of CD34+ cells after mobilization with preemptive use of plerixafor followed by leukocytapheresis on the same day

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