title: Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: a pilot study.
abstract: BACKGROUND
  Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy.
  
  
  METHODS
  Twenty women were enrolled. All patients received epirubicin 100 mg/m(2) with 5-fluorouracil 500 mg/m(2) and cyclophosphamide 500 mg/m(2) on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS).
  
  
  RESULTS
  The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group.
  
  
  CONCLUSIONS
  In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.
authors.affiliation: Oncology Unit, ICOT Hospital, Policlinico Umberto I Hospital, University of Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Rossi
authors.forename: Federica
authors.initials: F
authors.lastname: Tomao
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lo Russo
authors.forename: Anselmo
authors.initials: A
authors.lastname: Papa
authors.forename: Federica
authors.initials: F
authors.lastname: Zoratto
authors.forename: Raffaella
authors.initials: R
authors.lastname: Marzano
authors.forename: Enrico
authors.initials: E
authors.lastname: Basso
authors.forename: Erika
authors.initials: E
authors.lastname: Giordani
authors.forename: Monica
authors.initials: M
authors.lastname: Verrico
authors.forename: Fabio
authors.initials: F
authors.lastname: Ricci
authors.forename: Giulia
authors.initials: G
authors.lastname: Pasciuti
authors.forename: Edoardo
authors.initials: E
authors.lastname: Francini
authors.forename: Silverio
authors.initials: S
authors.lastname: Tomao
keywords: adjuvant anthracycline-based chemotherapy; bone pain; breast cancer; lenograstim; neutropenia; pegfilgrastim