Prophylactic Use of Erythropoietin in patients receiving chemotherapy for cancer

The study aims to compare prophylactic versus hemoglobin-based erythropoietin administration in patients receiving cytotoxic chemotherapy for early or advanced cancer. Eligible patients are randomized in two groups: Patients in Group A (experimental arm) receive prophylactic ESA (epoetin A, 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) with a target hemoglobin level of 14 mg/dl. If hemoglobin levels exceed this threshold, ESA administration is discontinued and is resumed when hemoglobin levels fell under 12 mg/dl. In group B, patients receive only iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) and ESA administration is initiated if hemoglobin levels fall below 11 mg/dl and are continued with a target of 13 mg/dl, at which point ESA support is discontinued, only to be resumed if hemoglobin levels fall again below 11 mg/dl. In both groups ESA administration is to be continued for four weeks after cessation of chemotherapy. The primary end-point of the study is safety, with emphasis on a composite outcome of thrombosis-related adverse events, while secondary endpoints include progression-free survival and overall survival.