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Strategies for the Use of Epoetin Alfa in Breast Cancer Patients

^a Division of Medical Oncology, St. Chiara Hospital, Pisa, Italy; ^b Medical Oncology Department, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy

Correspondence: Lucia Del Mastro, M.D., Oncologia Medica 1, Istituto Nazionale per la Ricerca sul Cancro, L.go Rosanna Benzi 10, 16132 Genova, Italy. Telephone: 39-10-5600666; Fax: 39-10-5600850; e-mail: mventur{at}hp380.ist.unige.it

Anemia is a common complication in cancer patients undergoing chemotherapy, and its severity depends on both the type of antineoplastic drugs and the clinical status of the patient. Breast cancer patients undergoing standard chemotherapy develop clinically significant anemia in up to 25% of cases. This percentage, moreover, increases up to 63% when more intensive chemotherapy regimens are used.

The therapeutic use of erythropoietin in anemic patients, i.e., in patients with hemoglobin levels below 9-10.5 g/dl, is able to correct the anemic status in nearly 40%-80% of such patients, but it does not completely eliminate the need of blood transfusions: 20%-40% of patients need to be transfused despite the erythropoietin treatment. An alternative strategy for optimizing the erythropoietin treatment is its use in the prevention of anemia, i.e., in patients with normal hemoglobin values but at high risk of becoming anemic. In a phase III study, we evaluated the role of erythropoietin in the prevention of anemia in breast cancer patients undergoing dose-intensive chemotherapy. Clinically significant anemia occurred in 52% (95% CI = 33-69) of control patients and in no patient (95% CI = 0-14) in the erythopoietin arm (p = .00001). After six cycles of chemotherapy the mean hemoglobin decrease was 3.05 g/dl (± 1.0, 95% CI = 2.6-3.5) in the control arm and 0.8 g/dl (± 1.4 , 95% CI = 0.3-1.4) in the erythropoietin arm. Moreover, 6.4% of control patients needed blood transfusion compared to no patients in the erythropoietin arm.

Erythropoietin is active in both the treatment and the prevention of anemia in cancer patients undergoing chemotherapy. Due to its high economic cost, efforts should be made to identify subsets of patients in whom the preventive use could be cost-effective. Patients undergoing chemotherapy associated with a high risk of anemia could benefit from preventive use of erythropoietin in special circumstances, such as presence of risk of myocardial or cerebral ischemia, uncommon blood group, or religious beliefs hindering blood transfusions. Moreover, anemia prevention could be considered in patients at high risk of requiring blood transfusions, such as patients with low baseline value of hemoglobin or with a hemoglobin decrease of 2 g/dl after the first cycle of chemotherapy.

Key Words. Breast • Anemia • Erythropoietin • Anemia prevention • Phase III study • Review