title: Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial.
abstract: This randomized phase 2 study explored the feasibility of delivering four to six cycles of the dose-intensified regimen FEC-100 (5-fluorouracil, epirubicin, and cyclophosphamide) to elderly patients with stage II-III breast cancer, using pegfilgrastim for neutrophil support. Sixty patients aged 65-77 years received single 6mg doses of pegfilgrastim on day 2 of FEC-100, either as primary prophylaxis (all cycles: PP), or as secondary prophylaxis (all cycles following a neutropenic event: SP). Neutropenic events (a composite endpoint that included grade 3 neutropenia+fever, grade 4 neutropenia, infectious complication requiring systemic anti-infectives and chemotherapy dose delay/reduction) occurred in 24/30 (80%) of the PP and 21/29 (72%) of the SP group in the first cycle. Most patients received all chemotherapy cycles at full dose on schedule (26/30 [87%] PP; 20/29 [69%] SP). These data indicate that delivery of FEC-100 is feasible with pegfilgrastim support in elderly breast cancer patients.
authors.affiliation: CRLC Val d'Aurelle, Montpellier, France.
authors.forename: G
authors.initials: G
authors.lastname: Romieu
authors.forename: M
authors.initials: M
authors.lastname: Clemens
authors.forename: R
authors.initials: R
authors.lastname: Mahlberg
authors.forename: P
authors.initials: P
authors.lastname: Fargeot
authors.forename: M
authors.initials: M
authors.lastname: Constenla
authors.forename: M
authors.initials: M
authors.lastname: Schütte
authors.forename: V
authors.initials: V
authors.lastname: Easton
authors.forename: T
authors.initials: T
authors.lastname: Skacel
authors.forename: P
authors.initials: P
authors.lastname: Bacon
authors.forename: W
authors.initials: W
authors.lastname: Brugger
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000633:toxicity; D015251:Epirubicin / Q000008:administration & dosage / Q000633:toxicity; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000008:administration & dosage / Q000633:toxicity; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000633:toxicity; D006801:Humans; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D009894:Opportunistic Infections / Q000139:chemically induced; D011092:Polyethylene Glycols; D011292:Premedication; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D015251:Epirubicin; D003520:Cyclophosphamide; D000069585:Filgrastim; D005472:Fluorouracil