Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial.
OBJECTIVE
Recombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients.


METHODS
This prospective, multicenter, open-label, randomized trial enrolled 157 patients with chemotherapy-related anemia (Hb <or= 105 g/L, serum ferritin <or= 450 pmol/L or <or= 675 pmol/L with transferrin saturation <or= 19%) receiving subcutaneously rHuEPO 40000 U once weekly to: (1). no-iron; (2). oral iron 325 mg twice daily; (3) iron dextran repeated 100mg IV bolus; or (4) iron dextran total dose infusion (TDI). Hb and quality of life (QOL) were measured at baseline and throughout.


RESULTS
All groups showed Hb (P <.0001) increases from baseline. Mean Hb increases for both IV iron groups were greater (P <.02) than for no-iron and oral iron groups. The percentage of patients with hematopoietic responses was higher (P <.01) in both IV iron groups (each case 68%) compared with no-iron (25%) and oral iron (36%) groups. IV iron groups showed increases in energy, activity, and overall QOL from baseline, compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group.


CONCLUSIONS
rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added.
Auerbach
Michael
M
Averbach Hematology-Oncology, Baltimore, MD, USA. mauerbachmd@aol.com
Ballard
Harold
H
Trout
J Richard
JR
McIlwain
Marilyn
M
Ackerman
Alan
A
Bahrain
Huzefa
H
Balan
Stefan
S
Barker
Lance
L
Rana
Jeevindra
J
D000014:Abnormalities, Drug-Induced; D000284:Administration, Oral; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage*; D007505:Iron-Dextran Complex / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins
D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D004921:Erythropoietin; D007505:Iron-Dextran Complex; D007501:Iron