title: Safety and activity of trastuzumab-containing therapies for the treatment of metastatic breast cancer: our long-term clinical experience (GOIM study).
abstract: BACKGROUND
  Trastuzumab is widely used as the treatment of choice for HER2-positive metastatic breast cancer (MBC).
  
  
  METHODS
  Seventy patients, median age 57 years and range 31-81 years, were included in our retrospective analysis with the aim to evaluate safety and activity of trastuzumab-containing therapies.
  
  
  RESULTS
  We observed for first-line treatment response rate (RR) 41%, stable disease (SD) 47% and time to progression (TTP) 8 months (range 1-44). Corresponding numbers for second line were RR 23%, SD 62% and (TTP) 9 months (range 3-23) and beyond second line RR 22%, SD 78% and (TTP) 9 months (range 4-19). Overall survival was 19.2 months (3-62 months). The median cumulative dose of trastuzumab administrated was 5286 mg (464-17 940 mg). Trastuzumab was well tolerated. Median left ventricular ejection function (LVEF) at baseline was 62% and at the end of treatment was 59%. The more relevant adverse events consisted of an asymptomatic decrease in LVEF to 40% (baseline 60%) and a grade 3 symptomatic increase in bilirubin.
  
  
  CONCLUSIONS
  Trastuzumab-containing therapies in MBC show a good safety and toxicity profile and a remarkable activity even in heavily pretreated women. Patients should benefit from continued trastuzumab therapy, as shown by the maintenance of (TTP) even beyond second-line treatment.
authors.affiliation: Department of Human Pathology, Medical Oncology and Integrated Therapies Unit, Universitary Policlinic G.Martino of Messina, Messina. adamovi@libero.it
authors.forename: V
authors.initials: V
authors.lastname: Adamo
authors.forename: T
authors.initials: T
authors.lastname: Franchina
authors.forename: B
authors.initials: B
authors.lastname: Adamo
authors.forename: G
authors.initials: G
authors.lastname: Ferraro
authors.forename: R
authors.initials: R
authors.lastname: Rossello
authors.forename: M
authors.initials: M
authors.lastname: Maugeri Saccà
authors.forename: C
authors.initials: C
authors.lastname: Scibilia
authors.forename: M R
authors.initials: MR
authors.lastname: Valerio
authors.forename: A
authors.initials: A
authors.lastname: Russo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies; D012983:Soft Tissue Neoplasms / Q000188:drug therapy / Q000556:secondary*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068878:Trastuzumab