title: Dose-tailoring of FEC adjuvant chemotherapy based on leukopenia is feasible and well tolerated. Toxicity and dose intensity in the Scandinavian Breast Group phase 3 adjuvant Trial SBG 2000-1.
abstract: The SBG 2000-1 trial is a randomised study that investigates if dose-tailored adjuvant FEC therapy based on the individual's leukocyte nadir value can improve outcome. The study has included 1535 women with medium and high-risk breast cancer.
  
  
  METHODS
  After a first standard dosed FEC course (5-fluorouracil 600 mg/m(2), epirubicin 60 mg/mg(2) and cyclophosphamide 600 mg/m(2)), patients who did not reach leukopenia grade III or IV were randomised to standard doses (group standard) or doses tailored to achieve grade III leukopenia (group tailored) at courses 2-7. Patients who achieved leukopenia grade III or more after the first course were not randomised but continued on standard doses (group registered).
  
  
  RESULTS
  Both planned and actually delivered number of courses (seven) were the same in all three arms. The relative dose intensity was increased by a factor of 1.31 (E 1.22, C 1.43) for patients in the tailored arm compared to the expected on standard dose. Ninety percent of the patients in the tailored arm achieved leukopenia grade III-IV compared with 29% among patients randomised to standard dosed therapy. Dose tailoring was associated with acceptable acute non-haematological toxicity with more total alopecia, nausea, vomiting and fatigue.
  
  
  CONCLUSIONS
  Dose tailoring according to leukopenia was feasible. It led to an increased dose intensity and was associated with acceptable excess of acute non-haematological toxicity.
authors.affiliation: Department of Oncology, Gävle Hospital, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Edlund
authors.forename: Johan
authors.initials: J
authors.lastname: Ahlgren
authors.forename: Karsten
authors.initials: K
authors.lastname: Bjerre
authors.forename: Michael
authors.initials: M
authors.lastname: Andersson
authors.forename: Jonas
authors.initials: J
authors.lastname: Bergh
authors.forename: Henning
authors.initials: H
authors.lastname: Mouridsen
authors.forename: Stig B
authors.initials: SB
authors.lastname: Holmberg
authors.forename: Nils-Olof
authors.initials: NO
authors.lastname: Bengtsson
authors.forename: Erik
authors.initials: E
authors.lastname: Jakobsen
authors.forename: Susanne
authors.initials: S
authors.lastname: Møller
authors.forename: Henrik
authors.initials: H
authors.lastname: Lindman
authors.forename: Carl
authors.initials: C
authors.lastname: Blomqvist
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007206:Individuality; D007970:Leukopenia / Q000139:chemically induced* / Q000453:epidemiology / Q000517:prevention & control; D008408:Mastectomy; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D057285:Precision Medicine / Q000379:methods; D012537:Scandinavian and Nordic Countries; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil