title: Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreated lymphoma patients.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy of pegfilgrastim, in combination with salvage chemotherapy, in mobilizing CD34(+) stem cells into the peripheral blood of pretreated lymphoma patients.
  
  
  METHODS
  This was an open-label phase II study including 25 pretreated patients (Hodgkin's disease=4; aggressive non-Hodgkin's lymphoma=21). The primary end-point of the study was the successful mobilization of a target cell dose of 2x10(6) CD34(+) cells/kg in lymphoma patients receiving ifosfamide, epirubicin and etoposide (IEV) chemotherapy and a fixed dose (6 mg) of pegfilgrastim given as single subcutaneous injection.
  
  
  RESULTS
  Following chemotherapy, all patients had grade 4 neutropenia that lasted a median of 1.5 days (1-3). Pegfilgrastim treatment was well tolerated and only 2/25 patients required pain-control medication. CD34+ cells were mobilized in all patients. The median (range) peak value of peripheral blood CD34+ cells after IEV chemotherapy and pegfilgrastim was 141x10(6)/L (12.8-386) and occurred almost invariably on day +14 (13-16). Twenty-three of the 25 patients underwent a single standard volume leukapheresis to collect a median of 8.7x10(6) CD34(+) cells/kg (1.78-17.3). Twenty four/25 patients (96%) reached the target cell dose of 2x10(6) CD34(+) cells/kg. High concentrations of circulating CD34+ cells (> 50x10(6)/L) were observed for several days after the achievement of the peak value. All the study patients were transplanted with their pegfilgrastim-mobilized CD34(+) cells and showed a rapid and sustained engraftment after high-dose chemotherapy.
  
  
  CONCLUSIONS
  Our results show that pegfilgrastim as an adjunct to chemotherapy is a predictable and highly effective mobilization regimen in pretreated lymphoma patients.
authors.affiliation: Institute of Hematology and Medical Oncology L. & A. Seràgnoli, University of Bologna, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Isidori
authors.forename: Monica
authors.initials: M
authors.lastname: Tani
authors.forename: Francesca
authors.initials: F
authors.lastname: Bonifazi
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Zinzani
authors.forename: Antonio
authors.initials: A
authors.lastname: Curti
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Motta
authors.forename: Simonetta
authors.initials: S
authors.lastname: Rizzi
authors.forename: Valeria
authors.initials: V
authors.lastname: Giudice
authors.forename: Oriana
authors.initials: O
authors.lastname: Farese
authors.forename: Manuela
authors.initials: M
authors.lastname: Rovito
authors.forename: Lapo
authors.initials: L
authors.lastname: Alinari
authors.forename: Roberto
authors.initials: R
authors.lastname: Conte
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Roberto M
authors.initials: RM
authors.lastname: Lemoli
mesh_terms: D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000096:biosynthesis; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D017024:Chemotherapy, Adjuvant; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000295:instrumentation / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D008223:Lymphoma / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D019172:Transplantation Conditioning
chemical_list: D018952:Antigens, CD34; D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim