title: Pooled analysis of cardiac safety in patients with cancer treated with pertuzumab.
abstract: BACKGROUND
  Pertuzumab, a human epidermal growth factor receptor (HER) 2 dimerization inhibitor, has demonstrated promising efficacy in combination with trastuzumab in patients with metastatic breast cancer. As HER signaling pathways are not only involved in oncogenesis, but also in myocardial homeostasis, an analysis of cardiac safety data was undertaken in a large group of patients treated with pertuzumab.
  
  
  METHODS
  A complete database of patients treated with full-dose pertuzumab was used to describe the incidence of asymptomatic left ventricular systolic dysfunction (LVSD) and symptomatic heart failure (HF).
  
  
  RESULTS
  Information for 598 unique patients was available for the current analysis. Of the patients treated with pertuzumab alone (n = 331) or pertuzumab in combination with a non-anthracycline-containing cytotoxic (n = 175) or trastuzumab (n = 93), 23 (6.9%), 6 (3.4%), and 6 (6.5%), respectively, developed asymptomatic LVSD and 1 (0.3%), 2 (1.1%), and 1 (1.1%), respectively, displayed symptomatic HF. None of the 15 patients receiving both pertuzumab and erlotinib demonstrated LVSD.
  
  
  CONCLUSIONS
  Patients treated with pertuzumab experienced relatively low levels of asymptomatic LVSD or symptomatic HF. There was no notable increase in cardiac side-effects when pertuzumab was given in combination with other anticancer agents.
authors.affiliation: Department of Cardiovascular Medicine, Vanderbilt University, Nashville, USA. Electronic address: daniel.lenihan@vanderbilt.edu.
authors.forename: D
authors.initials: D
authors.lastname: Lenihan
authors.affiliation: Department of Cardiology, Cardio-Oncology, Bern University Hospital and University of Bern, Bern, Switzerland.
authors.forename: T
authors.initials: T
authors.lastname: Suter
authors.affiliation: US Medical Affairs, BioOncology, Genentech, Inc., South San Francisco, USA.
authors.forename: M
authors.initials: M
authors.lastname: Brammer
authors.affiliation: Pharmaceutical Development, Biostatistics.
authors.forename: C
authors.initials: C
authors.lastname: Neate
authors.affiliation: Pharmaceutical Development Oncology, Roche Products Ltd, Welwyn Garden City, UK.
authors.forename: G
authors.initials: G
authors.lastname: Ross
authors.affiliation: Department of Medicine, Harvard Medical School; Division of Hematology/Oncology, Massachusetts General Hospital, Boston, USA.
authors.forename: J
authors.initials: J
authors.lastname: Baselga
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D017322:Clinical Trials, Phase II as Topic; D006321:Heart / Q000187:drug effects*; D006333:Heart Failure / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D018487:Ventricular Dysfunction, Left / Q000139:chemically induced / Q000453:epidemiology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C485206:pertuzumab