title: Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies.
abstract: BACKGROUND
  The expectation of improvement in patient survival with administration of new chemotherapy agents for metastatic breast carcinoma (MBC) is not consistently supported by data from clinical trials, which are often underpowered and have not detected moderate survival advantage. The aim of this study was to evaluate the impact of new agents on prognosis of MBC patients enrolled in clinical trials of first-line chemotherapy.
  
  
  METHODS
  Between 1983 and 2001, 640 MBC patients were entered into 6 consecutive trials; the present analysis was limited to patients. The date of diagnosis of metastatic breast disease was used to define 5 arbitrarily chosen 3-year time cohorts, 1983-1986, 1987-1989, 1992-1994, 1995-1997, and 1998-2001. Multivariate proportion of hazard (PH) models were used to evaluate changes in overall survival (OS) and progression-free survival (PFS) over time and to detect changes associated with the use of taxanes, while adjusting for differences in baseline factors among 5 cohorts.
  
  
  RESULTS
  Patient characteristics were evenly distributed across the 5 cohorts. Median OS was 18 months, 17.2 months, 19.2 months, 26.1 months, and 23.6 months, respectively, in cohorts 1983-1986, 1987-1989, 1992-1994, 1995-1997, 1998-2001 (P < 0.0001). Age, performance status, relapse-free survival, type of adjuvant treatment, metastatic site, and taxane first-line chemotherapy were all associated with survival. These data failed to provide an indication of temporal trend and suggested a reduction in hazard of death in two cohorts (1995-1997 and 1998-2001) where taxane was added to first-line chemotherapy.
  
  
  CONCLUSIONS
  The analysis provided evidence of improvement in prognosis of MBC patients that was associated with use of modern chemotherapeutic agents independent of time.
authors.affiliation: Department of Oncology, Division of Medical Oncology, Santa Chiara University Hospital, Pisa, Italy. gennari@med.unipi.it
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gennari
authors.forename: PierFranco
authors.initials: P
authors.lastname: Conte
authors.forename: Riccardo
authors.initials: R
authors.lastname: Rosso
authors.forename: Cinzia
authors.initials: C
authors.lastname: Orlandini
authors.forename: Paolo
authors.initials: P
authors.lastname: Bruzzi
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000556:secondary; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome