title: A randomized trial of two doses of cyclophosphamide with etoposide and G-CSF for mobilization of peripheral blood stem cells in 318 patients with stage II-III breast cancer.
abstract: The purpose of this study was to develop a less toxic outpatient chemotherapy regimen for mobilizing peripheral blood stem cells (PBSC). Three hundred eighteen patients with newly diagnosed stage II-III breast cancer who had received conventional dose adjuvant chemotherapy were randomized to receive intermediate-dose cyclophosphamide (2 g/m2), etoposide (600 mg/m2), and granulocyte colony-stimulating factor (G-CSF) 6 micrograms/kg/day (ID-Cy, n = 162) or high-dose cyclophosphamide (4 g/m2) and the same doses of etoposide and G-CSF (HD-Cy, n = 156) followed by collection of PBSC. Three hundred seventeen of 318 patients had apheresis performed, and 315 received high-dose chemotherapy (HDC) followed by PBSC support. The median numbers of CD34+ cells collected in a median of two apheresis following ID-Cy and HD-Cy were 19.9 and 22.2 x 10(6)/kg, respectively (p = 0.04). The fractions of patients achieving CD34+ cell doses > or = 2.5 or > or = 5.0 x 10(6)/kg were not different between the two regimens. More patients receiving HD-Cy had grade 3-4 nausea (p = 0.001), vomiting (p = 0.03), and mucositis (p = 0.04). The fractions of patients having a neutrophil nadir < 0.5 x 10(9)/L following ID-Cy and HD-Cy were 0.83 and 0.95, respectively (p = < 0.001). The fractions of patients having a platelet nadir < 25 x 10(9)/L following ID-Cy and HD-Cy were 0.13 and 0.51, respectively (p = < 0.001). More patients in the HD-Cy group received platelet (p < 0.001) and red blood cell (p < 0.001) transfusions and were admitted to the hospital more frequently (p = 0.03) than patients receiving ID-Cy. Three hundred fifteen patients received HDC followed by infusion of PBSC. There were no significant differences in the incidence of transplant-related death or early survival between patients receiving ID-Cy or HD-Cy followed by HDC. It was concluded that a regimen of Cy 2 g/m2 with etoposide and G-CSF was effective for mobilization of PBSC with low morbidity and resource utilization in patients with limited prior chemotherapy exposure.
authors.affiliation: Clinical Trials Division of Response Oncology, Inc., Memphis, TN 38117, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Schwartzberg
authors.forename: C H
authors.initials: CH
authors.lastname: Weaver
authors.forename: R
authors.initials: R
authors.lastname: Birch
authors.forename: C
authors.initials: C
authors.lastname: Manner
authors.forename: K
authors.initials: K
authors.lastname: Tauer
authors.forename: T
authors.initials: T
authors.lastname: Beeker
authors.forename: C
authors.initials: C
authors.lastname: Morgan-Ihrig
authors.forename: B
authors.initials: B
authors.lastname: MacAneny
authors.forename: R
authors.initials: R
authors.lastname: Leff
authors.forename: R
authors.initials: R
authors.lastname: Smith
authors.forename: J
authors.initials: J
authors.lastname: Hainsworth
authors.forename: T
authors.initials: T
authors.lastname: Greco
authors.forename: J
authors.initials: J
authors.lastname: Schwerkoske
authors.forename: M N
authors.initials: MN
authors.lastname: Murphy
authors.forename: C D
authors.initials: CD
authors.lastname: Buckner
mesh_terms: D000328:Adult; D018952:Antigens, CD34; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D003520:Cyclophosphamide