title: Treatment of metastatic breast cancer: a large observational study on adherence to French prescribing guidelines and financial cost of the anti-HER2 antibody trastuzumab.
abstract: OBJECTIVE
  This observational study aimed at analyzing adherence to prescribing guidelines of anti-HER2 monoclonal antibody trastuzumab treatment for metastatic breast cancer. Efficacy and costs were also evaluated.
  
  
  METHODS
  The adherence to the trastuzumab treatment plan was analyzed according to both the French postlicensing guidelines published in 2001 and clinical guidelines from the regional cancer network in a cohort of 131 consecutive patients.
  
  
  RESULTS
  The level of appropriateness to the molecular target was very high (92% of the patients showed a positive HER2 status, defined as HER2 3+ confirmed by immunohistochemistry or 2+ confirmed by fluorescent in situ hybridization). The treatment plan was made according to the French postlicensing guidelines in 41 patients (31.3%) and to the regional clinical guidelines for 109 patients (83.2%). The main reason for the difference was the type of molecules authorized for combination to trastuzumab. The median overall survival of the studied population was 18.6 months and the median progression-free survival rate was 7.7 months. Up to death or end of the study, the overall cost for the treatment of breast cancer with trastuzumab per patient and per year was 47,832 euro.
  
  
  CONCLUSIONS
  This quite low adherence of clinicians to the French postlicensing guidelines is in contrast with the high level of adherence to the regional clinical guidelines. The reason is that the latter are less rigid about previously received treatments and enlarge the potential associated cytotoxics to vinorelbine. This supports the French National Cancer Institute decision to get expert clinicians involved together with the French agency for sanitary security of health products and the high health authority in a common elaboration of guidelines.
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unit of Medico-Economic Evaluation, Lyon F-69003, France.
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Poncet
authors.forename: Cyrille
authors.initials: C
authors.lastname: Colin
authors.forename: Thomas
authors.initials: T
authors.lastname: Bachelot
authors.forename: Isabelle
authors.initials: I
authors.lastname: Jaisson-Hot
authors.forename: Laure
authors.initials: L
authors.lastname: Derain
authors.forename: Laurent
authors.initials: L
authors.lastname: Magaud
authors.forename: Cécile
authors.initials: C
authors.lastname: Fournel-Federico
authors.forename: Mireille
authors.initials: M
authors.lastname: Mousseau
authors.forename: Jean-Dominique
authors.initials: JD
authors.lastname: Tigaud
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Jacquin
authors.forename: Véronique
authors.initials: V
authors.lastname: Trillet-Lenoir
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000191:economics; D061067:Antibodies, Monoclonal, Humanized; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D015331:Cohort Studies; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D005602:France; D019983:Guideline Adherence; D006760:Hospitalization / Q000191:economics; D006801:Humans; D008297:Male; D008408:Mastectomy / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D017410:Practice Guidelines as Topic; D055656:Prescriptions / Q000191:economics / Q000592:standards*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000008:administration & dosage / Q000037:antagonists & inhibitors*; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D013997:Time Factors; D000068878:Trastuzumab; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab