title: Safety and efficacy outcomes with erythropoiesis-stimulating agents in patients with breast cancer: a meta-analysis.
abstract: BACKGROUND
  New data on erythropoiesis-stimulating agents (ESAs) regarding overall survival and disease progression-related outcomes in patients with breast cancer receiving chemotherapy are presented in a meta-analysis of controlled trials of ESA use (epoetin α, epoetin β, darbepoetin α, biosimilars).
  
  
  METHODS
  A literature search identified reports from January 1997 through March 2014. We used company databases for Amgen, Inc., or Janssen studies and published data for other studies. Random-effects odds ratios (ORs) were calculated to compare results for patients randomized to ESA with those randomized to control.
  
  
  RESULTS
  Deaths were reported for 571 of 2346 patients (24%) in the ESA groups and 523 of 2367 patients (22%) in the control groups [OR, 1.20; 95% confidence interval (CI) 1.03-1.40]. Sensitivity analyses were conducted to explore the effects of individual studies and exclusion of one study (BEST) resulted in an OR for death of 1.12 (95% CI 0.94-1.34). In seven studies reporting progression-related end points (N = 4197; ESA n = 2088; control n = 2109), the OR was 1.01 (95% CI 0.87-1.16) for ESA compared with control.
  
  
  CONCLUSIONS
  After incorporating recent results of ESA use in patients with breast cancer, risks of survival and progression-free survival remain consistent with previously published data.
authors.affiliation: Clinique de Genolier, Multidisciplinary Oncology Institute, Genolier, Switzerland. Electronic address: maapro@genolier.net.
authors.forename: M
authors.initials: M
authors.lastname: Aapro
authors.affiliation: Department of Gynecology and Obstetrics, Höchst Frankfurt Clinic, Academic Hospital of the Goethe University, Frankfurt.
authors.forename: V
authors.initials: V
authors.lastname: Moebus
authors.affiliation: Geriatric Breast Center, Evangelina Bethesda Hospital for Breast Diseases, Nordrhein-Westfalen, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Nitz
authors.affiliation: Texas Oncology Baylor Sammons Cancer Center, US Oncology, Dallas, USA.
authors.forename: J
authors.initials: J
authors.lastname: O'Shaughnessy
authors.affiliation: Department of Medical Oncology, National Institute for Cancer Research, IRCCS University Hospital San Martino - IST, Genova, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Pronzato
authors.affiliation: Department of Obstetrics and Gynecology, Helios Clinic Berlin-Buch, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Untch
authors.affiliation: Global Biostatistical Sciences, Amgen Inc., Thousand Oaks.
authors.forename: D
authors.initials: D
authors.lastname: Tomita
authors.affiliation: Global Biostatistical Sciences, Amgen Inc., Thousand Oaks.
authors.forename: C
authors.initials: C
authors.lastname: Bohac
authors.affiliation: Edith Sanford Breast Cancer Research, Sioux Falls, USA.
authors.forename: B
authors.initials: B
authors.lastname: Leyland-Jones
mesh_terms: D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D011379:Prognosis; D012449:Safety
chemical_list: D059451:Biosimilar Pharmaceuticals; D006397:Hematinics
keywords: breast cancer; chemotherapy-induced anemia; darbepoetin α; epoetin α; erythropoiesis-stimulating agents; meta-analysis