title: Observational study on adjuvant trastuzumab in HER2-positive early breast cancer patients.
abstract: OBJECTIVE
  This observational study investigates the use of adjuvant trastuzumab (AT) in HER2-positive breast cancer patients in a real-life setting, focusing on relapse and discontinuation rates.
  
  
  METHODS
  Data on a group of HER2-positive patients collected from 13 oncology centers of northeast Italy were analyzed.
  
  
  RESULTS
  In total, 1245 patients were analyzed. 13.1% of patients were excluded from AT because of comorbidities, age, tumor stage, refusal or other reasons; 8.2% of patients who received AT interrupted the therapy, mainly for toxicity. Overall the relapse rate was 10.9% in the AT-treated population versus 22.6% in nontreated patients (follow-up: 37.4 and 62.1 months, respectively). Disease-free survival (DFS) was lower in AT-relapsed patients than in not-relapsed. Statistical analysis showed a correlation between DFS and estrogen receptor status in AT-treated patients.
  
  
  CONCLUSIONS
  Relapse rates are lower in clinical setting compared to clinical trials. Overall, AT is effective in HER2-positive early-stage breast cancer patients.
authors.affiliation: Medical Oncology, University of Trieste, Via Lucrezio 9, 34134 Trieste, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Mustacchi
authors.forename: F
authors.initials: F
authors.lastname: Puglisi
authors.forename: A M
authors.initials: AM
authors.lastname: Molino
authors.forename: D
authors.initials: D
authors.lastname: Crivellari
authors.forename: C
authors.initials: C
authors.lastname: Ghiotto
authors.forename: A
authors.initials: A
authors.lastname: Ferro
authors.forename: A
authors.initials: A
authors.lastname: Brunello
authors.forename: S
authors.initials: S
authors.lastname: Saracchini
authors.forename: M
authors.initials: M
authors.lastname: Turazza
authors.forename: E
authors.initials: E
authors.lastname: Cretella
authors.forename: A
authors.initials: A
authors.lastname: Iop
authors.forename: M
authors.initials: M
authors.lastname: Malagoli
authors.forename: M
authors.initials: M
authors.lastname: Stefani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D008875:Middle Aged; D009367:Neoplasm Staging; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors / Q000378:metabolism*; D016019:Survival Analysis; D000068878:Trastuzumab / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab
keywords: HER2-positive early breast cancer; adjuvant trastuzumab; discontinuation rate; luminal B-HER2-positive; real-life study; relapse rate