title: A retrospective open-label uncontrolled study of Epoetin zeta on the treatment of chemotherapy-induced anemia in solid tumors.
abstract: OBJECTIVE
  This is a single-center uncontrolled retrospective study to evaluate the efficacy and safety of the biosimilar epoetin zeta after approval in chemotherapy-induced anemia (CIA).
  
  
  METHODS
  Patients screened were >18 years old suffering from solid malignancies and CIA with Hg ≤10 or <11 g/dl if symptomatic anemia. Patients had measurable disease by TNM and Eastern Cooperative Oncology Group (ECOG). Patients were treated for at least 12 weeks and the primary endpoint was to determine the incidence of blood transfusions, and secondarily, the overall safety and efficacy defined as ≥1 g/dl rise in Hb concentration or ≥40,000 cells/μl rise in reticulocyte count. Quality of life was assessed with ECOG performance status (PS) and functional assessment of cancer therapy-anemia (FACT-An) score.
  
  
  RESULTS
  1287 patients with median Hb 9.3 g/dl (range 8.3-10.6) were enrolled and included in the evaluation. Median age was 63 years (range 33-78). 74% of patients were stage III/IV. Patients received epoetin zeta subcutaneously at fixed 40,000-IU once weekly. Blood transfusions were given in 178 patients (13.8%; 95% CI 11.9-15.6%). Appropriate response was observed in 79% patients by week 4, 87% by week 8, and 91% by week 12. A mean Hb increase of 2.5 g/dl was observed by week 12 which correlated with an improvement in PS and Fact-An score. Thrombotic events occurred in 5.2% (95% CI 3.4-7.1%) of patients.
  
  
  CONCLUSIONS
  Epoetin zeta is effective in palliation and treatment of CIA in patients with solid tumors. Overall, it is well tolerated and safe even in patients with increased disease burden.
authors.affiliation: Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Μikras Asias (Building 16), Goudi,, 11527, Athens, Greece. kalifier@med.uoa.gr.|Department of Medical Oncology, "Henry Dunant" Hospital Center, Athens, Greece. kalifier@med.uoa.gr.|Department of Surgery, Agia Olga Hospital, Athens, Greece. kalifier@med.uoa.gr.
authors.forename: Constantinos E
authors.initials: CE
authors.lastname: Alifieris
authors.affiliation: Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Μikras Asias (Building 16), Goudi,, 11527, Athens, Greece.
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Orfanakos
authors.affiliation: Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Μikras Asias (Building 16), Goudi,, 11527, Athens, Greece.
authors.forename: Aristina
authors.initials: A
authors.lastname: Papanota
authors.affiliation: Department of Medical Oncology, "Henry Dunant" Hospital Center, Athens, Greece.
authors.forename: George P
authors.initials: GP
authors.lastname: Stathopoulos
authors.affiliation: Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Μikras Asias (Building 16), Goudi,, 11527, Athens, Greece.
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Sitaras
authors.affiliation: Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Μikras Asias (Building 16), Goudi,, 11527, Athens, Greece.|Department of Medical Oncology, "Henry Dunant" Hospital Center, Athens, Greece.
authors.forename: Dimitrios T
authors.initials: DT
authors.lastname: Trafalis
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; C530192:epoetin zeta; D004921:Erythropoietin
keywords: Anemia; Biosimilar; Chemotherapy; Epoetin zeta; Erythropoietin; Quality of life