title: Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group.
abstract: OBJECTIVE
  In our institution, adjuvant taxanes are currently offered to fit, node positive breast cancer patients who are either Her2 positive (any ER/PR) or triple negative (ER/PR/Her2 negative). The FE(100)C-D (FE(100)C × 3→docetaxel 100mg/m(2) × 3) regime, based on the PACS 01 trial [Roche H, Fumoleau P, Spielmann M, et al. Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for node positive Breast Cancer Patients: The FNCLCC PACS 01 Trial. J Clin Oncol 2006;24:5664-5671] is used. We retrospectively audited our experience with FE(100)C-D at The Beatson West of Scotland Cancer Centre and one representative district general hospital (DGH), Falkirk and District Royal Infirmary (FDRI).
  
  
  METHODS
  Over a two year period, 101 patients commenced adjuvant FE(100)C-D chemotherapy. Data was matched with the FE(100)C-D arm of the PACS 01 trial.
  
  
  RESULTS
  Median age was 54 years. Twenty-six patients (26%) had ≥ 1 episode of febrile neutropaenia (FN), including one fatal episode. Twenty-nine percent of patients required treatment interruption ≥ 1 week. Thirty percent of patients had dose reductions. Thirty percent of patients received <90% dose intensity of docetaxel.
  
  
  CONCLUSIONS
  The FN rate was substantially higher and docetaxel dose intensity substantially lower in our unselected sample of patients than in the reference study.(1) This 'real-life' data illustrates the problems of applying clinical trial data to the more generalised patient population.
authors.affiliation: The Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN, United Kingdom. judith.fraser@ggc.scot.nhs.uk
authors.forename: Judith
authors.initials: J
authors.lastname: Fraser
authors.forename: Nicola
authors.initials: N
authors.lastname: Steele
authors.forename: Aysha
authors.initials: A
authors.lastname: Al Zaman
authors.forename: Alison
authors.initials: A
authors.lastname: Yule
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D020714:Maximum Tolerated Dose; D008485:Medical Audit; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin