title: A phase II study of cyclophosphamide followed by PIXY321 as a means of mobilizing peripheral blood hematopoietic progenitor cells.
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.
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Lutheran General Hospital, Park Ridge, Illinois 60068, USA.
authors.forename: S
authors.initials: S
authors.lastname: Roman-Unfer
authors.forename: J D
authors.initials: JD
authors.lastname: Bitran
authors.forename: L
authors.initials: L
authors.lastname: Garrison
authors.forename: C
authors.initials: C
authors.lastname: Proeschel
authors.forename: S
authors.initials: S
authors.lastname: Hanauer
authors.forename: L
authors.initials: L
authors.lastname: Schroeder
authors.forename: L
authors.initials: L
authors.lastname: Johnson
authors.forename: L
authors.initials: L
authors.lastname: Klein
authors.forename: J
authors.initials: J
authors.lastname: Martinec
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001773:Blood Cells; D001855:Bone Marrow Diseases / Q000139:chemically induced / Q000628:therapy; D001943:Breast Neoplasms / Q000097:blood* / Q000188:drug therapy; D003114:Colony-Forming Units Assay; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000494:pharmacology*; D018380:Hematopoietic Stem Cell Transplantation; D006412:Hematopoietic Stem Cells / Q000187:drug effects*; D006801:Humans; D007377:Interleukin-3 / Q000494:pharmacology*; D007902:Length of Stay; D007937:Leukapheresis; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D007377:Interleukin-3; C078524:PIXY321 fusion protein, recombinant; D011993:Recombinant Fusion Proteins; D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; D005472:Fluorouracil