title: Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim.
abstract: BACKGROUND
  There is a misconception that elderly cancer patients cannot tolerate standard doses of chemotherapy because of the frequency and severity of myelosuppressive complications. The reactive use of colony-stimulating factors (i.e., in response to severe neutropenia) commonly observed in this setting contributes to the frequency and severity of these complications. This study evaluated the incidence of febrile neutropenia and related events in elderly cancer patients receiving pegfilgrastim beginning with cycle 1 (proactive) in comparison with pegfilgrastim initiated after cycle 1 at the physician's discretion (reactive).
  
  
  METHODS
  Patients (> or = 65 years of age) with either solid tumors or non-Hodgkin's lymphoma (NHL) were randomly assigned to receive pegfilgrastim either proactively or reactively. The primary endpoint was the proportion of patients experiencing febrile neutropenia.
  
  
  RESULTS
  There were 852 patients enrolled (median age, 72 years). Proactive pegfilgrastim use resulted in a significantly lower incidence of febrile neutropenia for both solid tumor and NHL patients compared with reactive use. Proactive pegfilgrastim use also led to fewer hospitalizations resulting from neutropenia and febrile neutropenia by approximately 50%. Antibiotic use was lower for solid tumor patients receiving proactive pegfilgrastim and equivalent in the two NHL groups.
  
  
  CONCLUSIONS
  This is the largest, randomized, prospective trial evaluating growth factor support in typical elderly cancer patients. Proactive pegfilgrastim use effectively produced a lower incidence of febrile neutropenia and related events in elderly patients with either solid tumors or NHL receiving an array of mild to moderately neutropenic chemotherapy regimens. Pegfilgrastim should be used proactively in elderly cancer patients to support the optimal delivery of standard chemotherapy.
authors.affiliation: H Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. Balducci@moffitt.usf.edu
authors.forename: Lodovico
authors.initials: L
authors.lastname: Balducci
authors.forename: Hafez
authors.initials: H
authors.lastname: Al-Halawani
authors.forename: Veena
authors.initials: V
authors.lastname: Charu
authors.forename: Jennifer
authors.initials: J
authors.lastname: Tam
authors.forename: Seta
authors.initials: S
authors.lastname: Shahin
authors.forename: Lyndah
authors.initials: L
authors.lastname: Dreiling
authors.forename: William B
authors.initials: WB
authors.lastname: Ershler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000188:drug therapy / Q000517:prevention & control*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim