title: T-DM1 as a New Treatment Option for Patients with Metastatic HER2-positive Breast Cancer in Clinical Practice.
abstract: OBJECTIVE
  To compare results of trastuzumab-emtansine (T-DM1) treatment in our clinical practice with data from phase III clinical trials.
  
  
  METHODS
  A retrospective chart review of all 23 patients with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who were started on T-DM1 until April 2014 was performed.
  
  
  RESULTS
  Four patients (17.4%) received T-DM1 as first-line, three (13.0%) as second-line, six (26.0%) as third-line, and 10 (43.5%) as fifth- or further-line therapy. Overall, the response rate (ORR) was 26.0%, disease control rate 78.3% and median progression-free survival (PFS) 8.4 months. The only toxicities of grade 3 or more were fatigue (21.7%), thrombocytopenia (4.3%) and elevation of liver enzymes (8.7%). ORR and PFS were similar to the TH3RESA and EMILIA trials. Compared to the EMILIA study, we recorded higher rates of newly-diagnosed cerebral metastasis and cerebral progression in patients with stable peripheral metastases.
  
  
  CONCLUSIONS
  T-DM1 is effective and well-tolerated even in intensively pre-treated patients.
authors.affiliation: National Center for Tumor Diseases, University Hospital, Heidelberg, Germany Department of Obstetrics and Gynecology, University Hospital, Heidelberg, Germany laura.michel@med.uni-heidelberg.de.
authors.forename: Laura L
authors.initials: LL
authors.lastname: Michel
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Germany.
authors.forename: Justo Lorenzo
authors.initials: JL
authors.lastname: Bermejo
authors.affiliation: Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.
authors.forename: Adam
authors.initials: A
authors.lastname: Gondos
authors.affiliation: National Center for Tumor Diseases, University Hospital, Heidelberg, Germany Department of Obstetrics and Gynecology, University Hospital, Heidelberg, Germany.
authors.forename: Frederik
authors.initials: F
authors.lastname: Marmé
authors.affiliation: National Center for Tumor Diseases, University Hospital, Heidelberg, Germany Department of Obstetrics and Gynecology, University Hospital, Heidelberg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
mesh_terms: D000080044:Ado-Trastuzumab Emtansine; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000556:secondary; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008453:Maytansine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010818:Practice Patterns, Physicians'; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000080044:Ado-Trastuzumab Emtansine; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D008453:Maytansine; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: HER2-positive metastatic breast cancer; T-DM1; chemotherapy