Researchers affiliated with CALGB have reported that the dose-dense adjuvant regimen ETC (epirubicin, paclitaxel, cyclophosphamide) supported by epoetin alfa (Epogen®, Procrit®) significantly reduces the number of red blood cell infusions, prevents anemia and does not increase relapses or effect overall survival. The details of this study were presented at the 2007 meeting of the American Society of Clinical Oncology in June.

The US Food and Drug Administration (FDA) has issued guidelines which suggest that targeting hemoglobin levels may increase relapses of some cancers and increase the incidence of clotting (see related news). The FDA cited data from a study carried out in Europe and Canada which reported that women with metastatic breast cancer who receive epoetin alfa to maintain hemoglobin levels between 12 and 14 g/dL have a decreased survival compared to control patients (see second item in related news). This has prompted researchers to reevaluate studies of epoetins in women with various stages of breast cancer.

The current study involved over 1,200 were women who were randomly allocated to receive dose-dense ETC versus a standard sequential regimen of EC followed by T. The 658 patients in the dose-dense ETC arm of the study were randomly allocated to receive epoetin alfa or no epoetin alfa. Transfusions were administered to 28% of the dose-dense ETC control patients compared to 13% of the epoetin alfa group. Hemoglogin levels in the epoetin alfa group were maintained at 12.4 g/dl. while the control group had average hemoglobin levels of 10.7 g/dl. despite more transfusions. At a median follow-up of 62 months the 5 year disease-free survival (DFS) was 71% for the control arm and 72% for the epoetin alfa arm while overall survival (OS) was 83% for the control arm and 83% for the epoetin alfa arm. These authors concluded that “the prevention of anemia has no influence on DFS and OS in the adjuvant treatment with dose-dense ETC”.

Comments: These data strongly support other observations that epoetins decrease transfusion requirements without increasing the relapse rate or increasing the rate of deaths from thromboembolism in women with localized breast cancer.

Reference:  Moebus V, Lueck H,  Thomssen C, et al. The impact of epoetin-alfa on anemia, red blood cell (RBC) transfusions, and survival in breast cancer patients (pts) treated with dose-dense sequential chemotherapy: Mature results of an AGO phase III study (ETC trial). Proceedings from the American Society of Clinical Oncology. Chicago/IL.  2007. Abstract # 569.  

Related News:  

New Guidelines on the Use of Procrit® and Ananesp® Released by the FDA (03/13/2007) 

Maintenance of Normal Hemoglobin With Procrit® May Decrease Survival of Patients With Metastatic Breast Cancer (09/02/2005) 

FDA MedWatch - Aranesp (darbepoetin alfa) - Warnings Revised to Include Reports of Increased mortality and Thrombotic Vascular Events (01/18/2005)