Recombinant human thrombopoietin augments mobilization of peripheral blood progenitor cells for autologous transplantation

This study assessed the ability of various schedules of recombinant human thrombopoietin (rhTPO) to enhance mobilization of peripheral blood progenitor cells (PBPCs) in 134 patients with cancer undergoing high-dose chemotherapy and autologous PBPC transplantation. Patients received the study drug on...

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Bibliographic Details
Published in:Biology of blood and marrow transplantation 2003-06, Vol.9 (6), p.405-413
Main Authors: Linker, Charles, Anderlini, Paolo, Herzig, Roger, Christiansen, Neal, Somlo, George, Bensinger, William, Fay, Joseph, Lynch, Joseph P, Goodnough, Lawrence T, Ashby, Mark, Benyunes, Mark C, Jones, Dennie V, Yang, Timothy A, Miller, Langdon L, Weaver, Charles
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Breast Neoplasms - drug therapy
Breast Neoplasms - therapy
Cohort Studies
Combined Modality Therapy
Double-Blind Method
Drug Administration Schedule
Female
Graft Survival
Granulocyte Colony-Stimulating Factor - administration & dosage
Granulocyte Colony-Stimulating Factor - pharmacology
Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage
Granulocyte-Macrophage Colony-Stimulating Factor - pharmacology
Hematopoietic Stem Cell Mobilization - methods
Humans
Leukapheresis
Lymphoma - drug therapy
Lymphoma - therapy
Male
Middle Aged
Mobilization
Multiple Myeloma - drug therapy
Multiple Myeloma - therapy
Peripheral Blood Stem Cell Transplantation
Recombinant Fusion Proteins - administration & dosage
Recombinant Fusion Proteins - pharmacology
Thrombopoietin
Thrombopoietin - administration & dosage
Thrombopoietin - genetics
Thrombopoietin - pharmacology
Transplantation, Autologous
Treatment Outcome
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Summary:This study assessed the ability of various schedules of recombinant human thrombopoietin (rhTPO) to enhance mobilization of peripheral blood progenitor cells (PBPCs) in 134 patients with cancer undergoing high-dose chemotherapy and autologous PBPC transplantation. Patients received the study drug on days 1, 3, and 5 before initiation of granulocyte colony-stimulating factor (G-CSF) 10 μg/kg/day on day 5 and pheresis starting on day 9. Randomly assigned treatments on days 1, 3, and 5 were: group 1 (n=27) placebo, placebo, rhTPO 1.5 μg/kg; group 2 (n=27) rhTPO 1.5 μg/kg, placebo, placebo; groups 3 (n=28) and 4 (n=22) rhTPO 0.5 μg/kg on all 3 treatment days; and group 5 (n=30) placebo on all 3 treatment days. After high-dose chemotherapy and PBPC transplantation, groups 1 through 4 received rhTPO 1.5 μg/kg days 0, +2, +4, and +6 with either G-CSF 5 μg/kg/day (groups 1-3) or granulocyte-macrophage colony-stimulating factor 250 μg/m 2/day (group 4). Group 5 received placebo plus G-CSF 5 μg/kg/day. The addition of rhTPO to G-CSF increased median CD34 + cell yield/pheresis in cohorts in which rhTPO was started before day 5, with higher yields in groups 2 (2.67 × 10 6/kg) and groups 3 and 4 (3.10 × 10 6/kg) than in group 1 (1.86 × 10 6/kg) or group 5 (1.65 × 10 6/kg) ( P=.006 across groups). Comparing rhTPO to placebo, higher percentages of patients achieved the minimum yield of CD34 + ≥2 × 10 6/kg (92% v 75%; P=.050) as well as the target yield of CD34 + ≥5 × 10 6/kg (73% v 46%; P=.041). rhTPO-treated patients required fewer phereses to achieve minimum ( P=.011) and target ( P=.015) CD34 + cell values. rhTPO given after transplantation did not speed platelet recovery. No neutralizing antibodies were observed. We conclude that rhTPO can safely enhance mobilization of PBPC, reduce the number of leukapheresis, and allow more patients to meet minimal cell yield requirements to receive high-dose chemotherapy with PBPC transplantation.
ISSN:1083-8791
1523-6536
DOI:10.1016/S1083-8791(03)00101-0