A phase II study of cyclophosphamide followed by PIXY321 as a means of mobilizing peripheral blood hematopoietic progenitor cells

S Roman-Unfer; J D Bitran; L Garrison; C Proeschel; S Hanauer; L Schroeder; L Johnson; L Klein; J Martinec

A phase II study of cyclophosphamide followed by PIXY321 as a means of mobilizing peripheral blood hematopoietic progenitor cells

Exp Hematol. 1996 Jun;24(7):823-8.

Authors

S Roman-Unfer¹, J D Bitran, L Garrison, C Proeschel, S Hanauer, L Schroeder, L Johnson, L Klein, J Martinec

Affiliation

¹ Department of Medicine, Division of Hematology/Oncology, Lutheran General Hospital, Park Ridge, Illinois 60068, USA.

PMID: 8647233

Abstract

Fourteen patients with stage II-IV breast cancer were enrolled in a phase II study of cyclophosphamide followed by PIXY321 as a means of mobilizing peripheral blood progenitor cells (PBPC). All 14 women tolerated PIXY321 well, with the predominant toxicities being erythema at the injection site, fever, and arthralgias. A median of two aphereses yielded a mean of 1.3 x 10(8) mononuclear cells/kg, 8.9 x 10(4) colony-forming units-granulocyte/macrophage (CFU-GM)/kg, and 4.5 x 10(6) CD34+ cells/kg. All 14 patients underwent high-dose chemotherapy with PBPC support, the median day to ANC >500 cells/microliter was 10.6, and the median day to platelets >20,000 cells/microliter was 13. The day of 90th percentile platelet recovery was 15. When compared to PBPCs mobilized by cyclophosphamide followed by GM-CSF, the use of PIXY321 may confer an advantage of enhanced platelet recovery.

Publication types

Clinical Trial
Clinical Trial, Phase II

MeSH terms

Adult
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Blood Cells
Bone Marrow Diseases / chemically induced
Bone Marrow Diseases / therapy
Breast Neoplasms / blood*
Breast Neoplasms / drug therapy
Colony-Forming Units Assay
Cyclophosphamide / administration & dosage
Cyclophosphamide / adverse effects
Cyclophosphamide / pharmacology*
Doxorubicin / administration & dosage
Doxorubicin / adverse effects
Female
Fluorouracil / administration & dosage
Fluorouracil / adverse effects
Granulocyte-Macrophage Colony-Stimulating Factor / pharmacology*
Hematopoietic Stem Cell Transplantation*
Hematopoietic Stem Cells / drug effects*
Humans
Interleukin-3 / pharmacology*
Length of Stay
Leukapheresis
Middle Aged
Recombinant Fusion Proteins / pharmacology*
Treatment Outcome

Substances

Interleukin-3
PIXY321 fusion protein, recombinant
Recombinant Fusion Proteins
Doxorubicin
Granulocyte-Macrophage Colony-Stimulating Factor
Cyclophosphamide
Fluorouracil

Supplementary concepts

CAF protocol