title: Effectiveness of trastuzumab in first-line HER2+ metastatic breast cancer after failure in adjuvant setting: a controlled cohort study.
abstract: BACKGROUND
  The evidence supporting the use of trastuzumab (T) in a metastatic setting comes from studies that included (almost) only patients who never received prior T. We investigated the effectiveness of T as first-line therapy for metastatic breast cancer (mBC) in women previously treated with T in the adjuvant setting.
  
  
  METHODS
  By using record linkage of five administrative health care databases of Lombardy, Italy, we identified 2,046 women treated with T for early breast cancer (eBC) in 2006-2009, 96 of whom developed a metastasis and were retreated with T in first-line treatment for mBC (treatment group). We compared the overall survival (OS) of these women with that of 197 women treated with T in first-line treatment for mBC, who were treated with therapies other than T for early disease (control group). We computed Kaplan-Meier 2-year OS and used a proportional hazard model to estimate the multivariate hazard ratio (HR) of death in the intervention group compared with the control group, adjusted by age, use of endocrine therapy, and site of metastasis.
  
  
  RESULTS
  Two-year OS was 60.0% in the treatment group and 59.5% in the control group. The adjusted HR of death in the treatment group compared with the control group was 0.79 (95% confidence interval, 0.50-1.26).
  
  
  CONCLUSIONS
  Our data provide convincing evidence that the outcome of women receiving first-line T treatment for mBC after T failure in the adjuvant setting is comparable to that of women not receiving T for eBC. These data are of specific interest, given the unavailability of data from randomized clinical trials.
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Eva
authors.initials: E
authors.lastname: Negri
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Zambelli
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Franchi
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Rossi
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Bonifazi
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Corrao
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Moja
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Zocchetti
authors.affiliation: Department of Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy; Unità Strutturale Complessa (USC) Oncologia, Ospedale Papa Giovanni XXIII, Bergamo, Italy; Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Milan, Italy; Department of Biomedical Sciences for Public Health, University of Milan, Milan, Italy; Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy; Operative Unit of Territorial Health Service, Health Directorate, Regione Lombardia, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy carlo.lavecchia@unimi.it.
authors.forename: Carlo
authors.initials: C
authors.lastname: La Vecchia
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases; D015996:Survival Rate; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab
keywords: Metastatic breast cancer; Overall survival; Record linkage; Trastuzumab