title: Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study.
abstract: BACKGROUND
  The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP).
  
  
  METHODS
  The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression.
  
  
  RESULTS
  The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months).
  
  
  CONCLUSIONS
  The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.
authors.affiliation: Institut Paoli-Calmettes, Oncologie Médicale, 232 Boulevard de St Marguerite, 13273 Marseille Cedex 9, France. extrajm@marseille.fnclcc.fr
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Extra
authors.forename: Eric C
authors.initials: EC
authors.lastname: Antoine
authors.forename: Anne
authors.initials: A
authors.lastname: Vincent-Salomon
authors.forename: Thierry
authors.initials: T
authors.lastname: Delozier
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Anne
authors.initials: A
authors.lastname: Bethune-Volters
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Guastalla
authors.forename: Marc
authors.initials: M
authors.lastname: Spielmann
authors.forename: Louis
authors.initials: L
authors.lastname: Mauriac
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Misset
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Christophe
authors.initials: C
authors.lastname: Hebert
authors.forename: Céline
authors.initials: C
authors.lastname: Remblier
authors.forename: Loïc
authors.initials: L
authors.lastname: Bergougnoux
authors.forename: Frank
authors.initials: F
authors.lastname: Campana
authors.forename: Moïse
authors.initials: M
authors.lastname: Namer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D019370:Observation; D017891:Pharmacoepidemiology; D011379:Prognosis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors; D012189:Retrospective Studies; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab