Pronzato, P., Cortesi, E., van der Rijt, C. C., Bols, A., Moreno-Nogueira, J. A., de Oliveira, C. F., . . . EPO-INT-47 Study Group. (2010). 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. Oncologist, 15, 935–943.
To evaluate the effects of treatment with epoetin alfa on anemia-related, patient-reported outcomes in women with breast cancer receiving myelotoxic chemotherapy.
Women with a hemoglobin level of 12 g/dL or less were randomized 1:1 to receive epoetin alfa (10,000 IU three times weekly) or best standard care during chemotherapy.
The study was a randomized, controlled phase IIIb trial.
On the FACT-An nonfatigue subscale, change was significantly better (p = 0.008) in the epoetin alfa group than in the best supportive care group. CLAS assessment showed that energy, ability to perform activities of daily living, and overall quality of life were significantly better (p = 0.007). No difference existed between groups in tumor response of survival. A significant increase was noted in transfusions in the best supportive care group (p = 0.048).
Epoetin alfa was well tolerated. Early administration in the treatment course attenuated deterioration in anemia-related, patient-reported outcomes.
New U.S. Food and Drug Administration (FDA) guidelines exist for the administration of epoetin alfa.