title: Primary chemotherapy in operable breast cancer with favorable prognostic factors: a pilot study evaluating the efficacy of a regimen with a low subjective toxic burden containing vinorelbine, 5-fluorouracil and folinic acid (FLN).
abstract: BACKGROUND
  Biological considerations support the use of primary chemotherapy in operable breast cancer; and despite wide variations of used regimens, clinical studies consistently show a significant tumor response allowing breast conservation in many patients otherwise candidates for mastectomy. We investigated the efficacy and the acceptance of a combination chemotherapy with vinorelbine, 5-fluorouracil and high-dose folinic acid in operable breast cancer with favorable prognostic factors and tested the relationship of hormone receptor status, Ki67,p53, c-erbB2 and bcl-2 with treatment response.
  
  
  METHODS
  Thirty-nine patients (median age 51 years, range 36-71 years), eight with T1, twenty-eight with T2 and two with T3 lesions, were treated with 5-fluorouracil (350 mg/m2, i.v. on day 1 to 3) preceded by folinic acid (100 mg/m2 i.v. on day 1 to 3) and vinorelbine, given on days 1 and 3 at the dose of 20 mg/m2 (FLN regimen). Therapy was administered on an outpatient basis every three weeks. Non responders had surgery after three courses, while complete or partial responders underwent surgery after six courses. All but one were evaluable for response and toxicity.
  
  
  RESULTS
  Objective responses were observed in 23 of the 38 evaluable patients (61%; 95% CI: 46%-76%): three complete responses (8%) and 20 partial responses (53%). Fifteen patients (39%) had stable disease, of whom nine (23%) had minor response. None of the patients had disease progression during treatment. Objective responses were significantly associated with no expression of estrogen and/or progesterone receptors and > 50% decrease in Ki67 after induction chemotherapy. Tolerance was excellent and none of the patients experienced grade 2 alopecia.
  
  
  CONCLUSIONS
  The 'moderate' efficacy of this regimen might be partially due to the selection of patients with high expression of steroid hormone receptors and low proliferation rate, which have an unfavorable impact on response to this chemotherapy.
authors.affiliation: Division of Medical Oncology, European Institute of Oncology, Milan, Italy. fnole@ieo.it
authors.forename: F
authors.initials: F
authors.lastname: Nolè
authors.forename: I
authors.initials: I
authors.lastname: Minchella
authors.forename: M
authors.initials: M
authors.lastname: Colleoni
authors.forename: E
authors.initials: E
authors.lastname: Orvieto
authors.forename: E
authors.initials: E
authors.lastname: Munzone
authors.forename: F
authors.initials: F
authors.lastname: de Braud
authors.forename: G
authors.initials: G
authors.lastname: Peruzzotti
authors.forename: G
authors.initials: G
authors.lastname: Martinelli
authors.forename: M G
authors.initials: MG
authors.lastname: Zampino
authors.forename: C
authors.initials: C
authors.lastname: Catania
authors.forename: M
authors.initials: M
authors.lastname: Pizzamiglio
authors.forename: P
authors.initials: P
authors.lastname: Veronesi
authors.forename: S
authors.initials: S
authors.lastname: Zurrida
authors.forename: V
authors.initials: V
authors.lastname: Galimberti
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: U
authors.initials: U
authors.lastname: Veronesi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011379:Prognosis; D011960:Receptors, Estrogen / Q000032:analysis / Q000187:drug effects; D011980:Receptors, Progesterone / Q000032:analysis / Q000187:drug effects; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D014747:Vinblastine; D002955:Leucovorin; D000077235:Vinorelbine; D005472:Fluorouracil