Efficacy and safety of a biogeneric recombinant human erythropoietin in the management of chemotherapy-induced anemia: a randomized double-blind active-comparator trial

• Published in: Comparative clinical pathology 2016, Vol.25 (1), p.155-160
• Main Authors: Panahi, Yunes, Saadat, Alireza, Imani, Saber, Sahebkar, Amirhossein
• Format: Article
• Language: English
• Subjects: Hematology; Medicine; Medicine & Public Health; Oncology; Original Article; Pathology
• ISSN: 1618-5641; 1618-565X
• DOI: 10.1007/s00580-015-2158-0

Anemia is a common complication of chemotherapy, and its presence affects the quality of life of cancer patients. Recombinant human erythropitein (rHuEPO) is the mainstay of treatment in patients suffering from chemotherapy-induced anemia. Since rHuEPO is a costly treatment, development of biogeneric products with equivalent efficacy and safety is an essential requirement. This study aimed to compare the efficacy and safety of a biogeneric rHuEPO (Epolyrec®) with those of the original brand-name product (Eprex®). Seventy-seven cancer patients with hemoglobin levels 100 ng/dL, and a life expectancy of at least 6 months were recruited into the trial. Included subjects were randomly assigned to either Epolyrec® ( n  = 37) or Eprex® ( n  = 40) at a weekly dose of 100 IU/kg (divided in three doses), for a period of 8 weeks. Hemoglobin and hematocrit levels were significantly increased by week 4 in the Epolyrec® group ( p   0.05). There was no report of severe adverse events in either of the study groups. The present findings support equivalent efficacy and safety of Epolyrec® and Eprex® in the management of chemotherapy-induced anemia.