title: Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy.
abstract: OBJECTIVE
  Dose-dense, every-2-week adjuvant chemotherapy using doxorubicin/cyclophosphamide (AC; 60/600 mg/m2 every 2 weeks x four cycles) followed by paclitaxel (175 mg/m2 every 2 weeks x four cycles), requiring filgrastim on days 3 through 10 of each cycle has been shown to improve survival compared with every-3-week treatment schedules but is associated with greater risk of RBC transfusion (13%). The role of long-acting hematopoietic growth factors in facilitating every-2-week chemotherapy and minimizing hematologic toxicity has not been established.
  
  
  METHODS
  Women with stage I to III breast cancer received dose-dense AC --> paclitaxel as neoadjuvant or adjuvant chemotherapy. Patients received pegfilgrastim 6 mg subcutaneous (SQ) on day 2 of each cycle. Darbepoetin alfa was initiated at 200 microg SQ every 2 weeks for hemoglobin < or = 12 g/dL, and administered thereafter, according to a preplanned algorithm. The primary end points were to evaluate the percentage of patients with febrile neutropenia and the percentage of patients requiring RBC transfusion.
  
  
  RESULTS
  Among 135 women treated on this single arm study, there were two cases of febrile neutropenia (incidence 1.5%). No patients received RBC transfusion. Darbepoetin alfa therapy was initiated in 92% of patients. The modest leukocytosis seen during paclitaxel cycles was attributable, in part, to corticosteroid premedication. Other toxicity and dose-delivery were similar to dose-dense AC --> paclitaxel in Cancer and Leukemia Group B 9741.
  
  
  CONCLUSIONS
  Pegfilgrastim and darbepoetin alfa are effective and safe in facilitating every-2-week AC --> paclitaxel, minimizing rates of febrile neutropenia and RBC transfusion.
authors.affiliation: Dana-Farber Cancer Institute, Boston, MA 02115, USA. hburstein@partners.org
authors.forename: Harold J
authors.initials: HJ
authors.lastname: Burstein
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Parker
authors.forename: Aparna
authors.initials: A
authors.lastname: Keshaviah
authors.forename: Jennifer
authors.initials: J
authors.lastname: Doherty
authors.forename: Ann H
authors.initials: AH
authors.lastname: Partridge
authors.forename: Lidia
authors.initials: L
authors.lastname: Schapira
authors.forename: Paula D
authors.initials: PD
authors.lastname: Ryan
authors.forename: Jerry
authors.initials: J
authors.lastname: Younger
authors.forename: Lyndsay N
authors.initials: LN
authors.lastname: Harris
authors.forename: Beverly
authors.initials: B
authors.lastname: Moy
authors.forename: Steven E
authors.initials: SE
authors.lastname: Come
authors.forename: Susan T
authors.initials: ST
authors.lastname: Schumer
authors.forename: Craig A
authors.initials: CA
authors.lastname: Bunnell
authors.forename: Margaret
authors.initials: M
authors.lastname: Haldoupis
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gelman
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D000740:Anemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001900:Boston / Q000453:epidemiology; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D000068256:Darbepoetin alfa; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000068256:Darbepoetin alfa; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D000069585:Filgrastim