title: Patient database analysis of fulvestrant 500 mg in the treatment of metastatic breast cancer: A European perspective.
abstract: BACKGROUND
  Clinical guidelines recommend that patients with hormone receptor (HR)-positive metastatic breast cancer (MBC) should be preferentially treated with endocrine therapy. Fulvestrant (a selective estrogen receptor degrader) is approved for use in these patients following relapse after, or relapse or progression during, antiestrogen therapy. This descriptive study analyzed European treatment patterns for HR-positive MBC in real-world clinical practice.
  
  
  METHODS
  The IMS Oncology Analyzer (OA), a retrospective cancer treatment database reporting physician-entered patient case histories, was used to identify records for postmenopausal women with HR-positive MBC from April 1, 2004 to June 30, 2013 in France, Germany, Italy, and Spain. Treatments were allocated to mutually exclusive categories (fulvestrant-containing, aromatase inhibitor [AI]-containing, tamoxifen-containing, or chemotherapy-containing regimens) and assessed by line of therapy for MBC. Fulvestrant use was also assessed pre- and post-2010 (when fulvestrant 500 mg dosing was approved).
  
  
  RESULTS
  In total, 27,214 eligible patients were included (France: 6801; Germany: 6852; Italy: 7061; Spain: 6500). Chemotherapy-based regimens were the most common first-line treatments for MBC across all countries. Across countries, the proportion of patients initiating on each treatment category ranged from: chemotherapy, 57.5-70.4%; AI, 23.5-30.1%; tamoxifen, 2.7-9.8%; fulvestrant 0.8-2.6%. When administered, fulvestrant was usually given as first- or second-line treatment. Post-2010, more patients received fulvestrant 500 mg than fulvestrant 250 mg in France, Germany, and Spain; in Italy, more patients continued to receive fulvestrant 250 mg.
  
  
  CONCLUSIONS
  Most patients with HR-positive MBC receive chemotherapy over endocrine therapy; fulvestrant constitutes a small proportion of treatments for such patients.
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University of Rome and IDI-IRCCS, Rome, Italy. Electronic address: paolo.marchetti@ospedalesantandrea.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Marchetti
authors.affiliation: Department of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein, Kiel, Germany.
authors.forename: Nicolai
authors.initials: N
authors.lastname: Maass
authors.affiliation: Department of Medical Oncology, INSERM U938, APHP Tenon, IUC-UPMC, Sorbonne University, Paris, France.
authors.forename: Joseph
authors.initials: J
authors.lastname: Gligorov
authors.affiliation: Real World Evidence Solutions and HEOR, IMS Health, Munich, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Berger
authors.affiliation: Real World Evidence Solutions and HEOR, IMS Health, London, United Kingdom.
authors.forename: Finlay
authors.initials: F
authors.lastname: MacDougall
authors.affiliation: AstraZeneca, London, United Kingdom.
authors.forename: Jukka
authors.initials: J
authors.lastname: Montonen
authors.affiliation: AstraZeneca, London, United Kingdom.
authors.forename: Jan
authors.initials: J
authors.lastname: Lewis
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D016208:Databases, Factual; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005602:France; D000077267:Fulvestrant; D005858:Germany; D006801:Humans; D007558:Italy; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D012189:Retrospective Studies; D013030:Spain; D013629:Tamoxifen / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D000077267:Fulvestrant; D004958:Estradiol
keywords: Chemotherapy; Endocrine therapy; Guidelines; Hormone receptor-positive breast cancer; Quality of care; Treatment patterns