title: Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients.
abstract: BACKGROUND
  The magnitude of the survival benefit of taxanes as adjuvant chemotherapy for early breast cancer is still unclear. A pooled analysis of Phase III trials was performed to assess the advantages that adjuvant taxane chemotherapy has over standard chemotherapy.
  
  
  METHODS
  All Phase III trials were considered eligible. A pooled analysis was accomplished and event-based relative risk ratios (RR) with 95% confidence intervals (95% CI) were derived. The significant differences in disease-free survival (DFS) and overall survival (OS) were explored. Magnitude outcome measures were absolute benefits and the number of patients needed to treat. A heterogeneity test was applied as well. A sensitivity analysis in 6 subpopulations was also performed.
  
  
  RESULTS
  Nine trials designed to assess if paclitaxel or docetaxel improve survival (15,598 patients) were gathered. One of the 9 trials did not report OS results. Significant differences in favor of taxanes were seen in DFS in the overall (RR: 0.86; 95% CI, 0.81-0.90 [P<.00001]) and lymph node-positive population (RR: 0.84; 95% CI, 0.79-0.89 [P<.0001]), and in OS in the overall (RR: 0.87; 95% CI, 0.81-0.83 [P<.0001]) and lymph node-positive population (RR: 0.84; 95% CI, 0.77-0.92 [P<.0001]). The absolute benefits in DFS and OS in favor of taxanes ranged from 3.3% to 4.6% and from 2.0% to 2.8%, respectively.
  
  
  CONCLUSIONS
  Considering all the available Phase III trials, taxane-based adjuvant chemotherapy for early breast cancer seems to add a significant benefit in both DFS and OS over standard chemotherapy. The lack of significant heterogeneity in the sensitivity analysis underscores the homogeneous effect across all trials.
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. emiliobria@yahoo.it
authors.forename: Emilio
authors.initials: E
authors.lastname: Bria
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nistico
authors.forename: Federica
authors.initials: F
authors.lastname: Cuppone
authors.forename: Paolo
authors.initials: P
authors.lastname: Carlini
authors.forename: Mariangela
authors.initials: M
authors.lastname: Ciccarese
authors.forename: Michele
authors.initials: M
authors.lastname: Milella
authors.forename: Guido
authors.initials: G
authors.lastname: Natoli
authors.forename: Edmondo
authors.initials: E
authors.lastname: Terzoli
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use*; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel