title: Dose dense cyclophosphamide, methotrexate, fluorouracil is feasible at 14-day intervals: a pilot study of every-14-day dosing as adjuvant therapy for breast cancer.
abstract: OBJECTIVE
  Cyclophosphamide/methotrexate/fluorouracil (CMF) is a proven adjuvant option for patients with early-stage breast cancer. Randomized trials with other regimens demonstrate that dose-dense (DD) scheduling can offer greater efficacy. We investigated the feasibility of administering CMF using a DD schedule.
  
  
  METHODS
  Thirty-eight patients with early-stage breast cancer were accrued from March 2008 through June 2008. They were treated every 14 days with C 600, M 40, F 600 (all mg/m2) with PEG-filgrastim (Neulasta®) support on day 2 of each cycle. The primary endpoint was tolerability using a Simon's 2-stage optimal design. The design would effectively discriminate between true tolerability (as protocol-defined) rates of ≤ 60% and ≥ 80%.
  
  
  RESULTS
  The median age was 52-years-old (range, 38-78 years of age). Twenty-nine of the 38 patients completed 8 cycles of CMF at 14-day intervals.
  
  
  CONCLUSIONS
  Dose-dense adjuvant CMF is tolerable and feasible at 14-day intervals with PEG-filgrastim support.
authors.affiliation: Department of Medicine, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center at Rockville Centre, 1000 North Village Ave., Rockville Centre, NY 11570, USA. drullinp@mskcc.org
authors.forename: Pamela
authors.initials: P
authors.lastname: Drullinsky
authors.forename: Steven M
authors.initials: SM
authors.lastname: Sugarman
authors.forename: Monica N
authors.initials: MN
authors.lastname: Fornier
authors.forename: Gabriella
authors.initials: G
authors.lastname: D'Andrea
authors.forename: Teresa
authors.initials: T
authors.lastname: Gilewski
authors.forename: Diana
authors.initials: D
authors.lastname: Lake
authors.forename: Tiffany
authors.initials: T
authors.lastname: Traina
authors.forename: Carolyn
authors.initials: C
authors.lastname: Wasserheit-Lieblich
authors.forename: Nancy
authors.initials: N
authors.lastname: Sklarin
authors.forename: Deena
authors.initials: D
authors.lastname: Atieh-Graham
authors.forename: Nancy
authors.initials: N
authors.lastname: Mills
authors.forename: Tiffany
authors.initials: T
authors.lastname: Troso-Sandoval
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Seidman
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Yuan
authors.forename: Hamangi
authors.initials: H
authors.lastname: Patel
authors.forename: Sujata
authors.initials: S
authors.lastname: Patil
authors.forename: Larry
authors.initials: L
authors.lastname: Norton
authors.forename: Clifford
authors.initials: C
authors.lastname: Hudis
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate