title: Randomized trial of high-dose chemotherapy and hematopoietic progenitor-cell support in operable breast cancer with extensive lymph node involvement: final analysis with 7 years of follow-up.
abstract: BACKGROUND
  The aim of this study was to present an update of overall (OS) and disease-free survival (DFS) and to evaluate the correlation between outcome and pathological findings at surgery in a randomized trial of high-dose chemotherapy following neoadjuvant chemotherapy and surgery in high-risk breast cancer patients.
  
  
  METHODS
  Ninety-seven women <60 years of age with breast cancer and extensive axillary lymph node involvement received three courses of FE120C (5-fluorouracil 500 mg/m2, epirubicin 120 mg/m2, cyclophosphamide 500 mg/m2) followed by surgery. Eighty-one patients were randomized to receive either a fourth FE120C course alone or a fourth FE120C course followed by high-dose chemotherapy (cyclophosphamide 6 g/m2, thiotepa 480 mg/m2, carboplatin 1600 mg/m2). We performed a univariate analysis on possible prognostic factors and analyzed the sites of relapse.
  
  
  RESULTS
  After a median follow-up of 6.9 years, 47 (48%) patients were alive, of whom 36 (38%) were without disease. Sixty patients relapsed after treatment. One patient died of myelodysplastic syndrome, without a relapse. In intention-to-treat analysis, the 5-year DFS rates were 47.5% in the conventional treatment arm and 49% in the high-dose arm, and the 5-year OS rates were 62.5% and 61%, respectively. In the univariate analysis, the clinical T-stage before chemotherapy and the number of tumor-positive axillary lymph nodes after induction chemotherapy (P = 0.027) were significant prognostic factors for OS. The same factors (both P = 0.06) plus the estrogen receptor (P = 0.08) were borderline significant factors for DFS.
  
  
  CONCLUSIONS
  After a median follow-up of 6.9 years there was no difference in OS or DFS rates between the two treatment groups. The number of tumor-positive axillary lymph nodes after induction chemotherapy and the clinical T-stage before chemotherapy were significant factors for OS.
authors.affiliation: Division of Medical Oncology, The Netherlands Cancer Institute, Amsterdam. j_schrama@nki.nl
authors.forename: J G
authors.initials: JG
authors.lastname: Schrama
authors.forename: I F
authors.initials: IF
authors.lastname: Faneyte
authors.forename: J H
authors.initials: JH
authors.lastname: Schornagel
authors.forename: J W
authors.initials: JW
authors.lastname: Baars
authors.forename: J L
authors.initials: JL
authors.lastname: Peterse
authors.forename: M J
authors.initials: MJ
authors.lastname: van de Vijver
authors.forename: O
authors.initials: O
authors.lastname: Dalesio
authors.forename: H
authors.initials: H
authors.lastname: van Tinteren
authors.forename: E J T
authors.initials: EJ
authors.lastname: Rutgers
authors.forename: D J
authors.initials: DJ
authors.lastname: Richelt
authors.forename: S
authors.initials: S
authors.lastname: Rodenhuis
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001707:Biopsy, Needle; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007150:Immunohistochemistry; D008207:Lymphatic Metastasis / Q000473:pathology*; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome