title: Myeloprotective effect of early primary granulocyte-colony stimulating factor during six courses of intensified 5-fluorouracil, epirubicin and cyclophosphamide (120FEC) chemotherapy for advanced breast cancer. Cooperative Group of Study and Treatment of Breast Cancer.
abstract: OBJECTIVE
  The neutropenia induced by six courses of an intensified FEC regimen is expected to be checked by early primary administration of G-CSF which is stopped eight days before the next chemotherapy course. Less information is available about megakaryocytic and erythroid toxicity over six courses.
  
  
  METHODS
  Sixty-six consecutive patients with metastatic breast cancer completed six courses of a randomized treatment with two FEC regimens administered every 21 days, in which 600 mg/m2 of cyclophosphamide and 5-FUwas associated with 60 or 120 mg/m2 of epirubicin (60FEC, 35 patients, vs 120FEC, 31 patients). 120FEC was supported by early primary G-CSF (days 4 to 13). Blood counts were obtained seven times during each course.
  
  
  RESULTS
  The non-hematologic toxicity over 364 courses was similar in 60FEC and 120FEC. No cumulative hematologic toxicity was observed for white blood cells (WBC) and platelets (PLT), while for hemoglobin (Hb) a somewhat higher cumulative toxicity was observed with 120FEC than with 60FEC. WBC, PLT and Hb grade III-IV toxicity occurred in 40.1% and 45.6% (P=ns), in 23.1% and 0.8% (P <.0001) and in 15.6% and 3.0% (P <.005) of the two regimens, respectively. There were no febrile or hemorrhagic episodes. The epirubicin relative dose intensity delivered was 1.95 in 120FEC with respect to 60FEC.
  
  
  CONCLUSIONS
  Our G-CSF schedule permitted to deliver six courses of 120FEC without any clinically relevant side effects. Grade III-IV leukopenia was similar with 120FEC and 60FEC, while grade III-IV thrombocytopenia and anemia occurred more often with 120FEC than with 60FEC.
authors.affiliation: Medicina Interna e Oncologia Medica, Università and IRCCS Policlinico San Matteo, Pavia, Italy. riccardi@mbox.medit.it
authors.forename: A
authors.initials: A
authors.lastname: Riccardi
authors.forename: S
authors.initials: S
authors.lastname: Brugnatelli
authors.forename: M
authors.initials: M
authors.lastname: Giordano
authors.forename: M
authors.initials: M
authors.lastname: Danova
authors.forename: P
authors.initials: P
authors.lastname: Pugliese
authors.forename: C
authors.initials: C
authors.lastname: Tinelli
authors.forename: C
authors.initials: C
authors.lastname: Klersy
authors.forename: A
authors.initials: A
authors.lastname: Richetti
authors.forename: S
authors.initials: S
authors.lastname: Fava
authors.forename: G
authors.initials: G
authors.lastname: Nastasi
authors.forename: E
authors.initials: E
authors.lastname: Rinaldi
authors.forename: V
authors.initials: V
authors.lastname: Fregoni
authors.forename: A
authors.initials: A
authors.lastname: De Monte
authors.forename: G
authors.initials: G
authors.lastname: Trotti
authors.forename: A
authors.initials: A
authors.lastname: Bovio
authors.forename: E
authors.initials: E
authors.lastname: Ascari
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001853:Bone Marrow / Q000187:drug effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil