title: Epoetin alfa improves anemia and anemia-related, patient-reported outcomes in patients with breast cancer receiving myelotoxic chemotherapy: results of a European, multicenter, randomized, controlled trial.
abstract: OBJECTIVE
  To evaluate the effects of epoetin alfa on patient-reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy.
  
  
  METHODS
  Women with hemoglobin concentrations ≤ 12.0 g/dl and an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-3 were randomized 1:1 to receive epoetin alfa (10,000 IU 3 times weekly) or best standard care (BSC) during chemotherapy. The primary endpoint was the change from baseline in the total anemia subscale assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire after 12 weeks of treatment. The fatigue and nonfatigue subscales from the FACT-An, the Cancer Linear Analog Scale (CLAS), hemoglobin changes, ECOG PS score, tumor response, overall survival, and safety also were evaluated.
  
  
  RESULTS
  Of 223 patients randomized, 216 constituted the modified intent-to-treat population. Percentage changes in the total anemia subscale of the FACT-An were significantly different between epoetin alfa treatment (14.2%) and BSC (-0.5%; p = .002), favoring epoetin alfa; so were changes in the FACT-An fatigue subscale (epoetin alfa, 17.5%; BSC, -0.9%; p = .003) and nonfatigue subscale (epoetin alfa, 8.8%; BSC, 0.2%; p = .008). Similar results were observed with the CLAS. Hemoglobin concentrations > 12 g/dl were more common with epoetin alfa (62.0%) than with BSC (27.6%). Tumor response, ECOG PS score, 12-month survival rate, and the incidence of serious treatment-emergent adverse events were similar between groups.
  
  
  CONCLUSIONS
  Early intervention with epoetin alfa was well tolerated and improved anemia-related PROs in patients with breast cancer receiving myelotoxic chemotherapy.
authors.affiliation: Department of Medical Oncology A, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. ppronza@tin.it
authors.forename: Paolo
authors.initials: P
authors.lastname: Pronzato
authors.forename: Enrico
authors.initials: E
authors.lastname: Cortesi
authors.forename: Carin C
authors.initials: CC
authors.lastname: van der Rijt
authors.forename: Alain
authors.initials: A
authors.lastname: Bols
authors.forename: José A
authors.initials: JA
authors.lastname: Moreno-Nogueira
authors.forename: Carlos Freire
authors.initials: CF
authors.lastname: de Oliveira
authors.forename: Peter
authors.initials: P
authors.lastname: Barrett-Lee
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Ostler
authors.forename: Ricardo
authors.initials: R
authors.lastname: Rosso
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001803:Blood Transfusion; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa
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