July 29, 2013
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Epoetin-alfa reduced anemia, need for transfusions in high-risk breast cancer

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The addition of the erythropoiesis-stimulating agent epoetin-alfa to chemotherapy reduced the risk for anemia in patients with high-risk breast cancer, according to study results published in the Journal of the National Cancer Institute.

Although epoetin-alfa did not negatively affect RFS or OS, it did increase the risk for thrombotic events in this patient population, researchers added.

In a previous study, researchers compared 5-year RFS of patients with high-risk breast cancer assigned to one of two adjuvant treatment regimens: intense dose-dense sequential chemotherapy plus epirubicin, paclitaxel and cyclophosphamide every 2 weeks, or conventional scheduled epirubicin/cyclophosphamide followed by paclitaxel every 3 weeks.

 

Clifford A. Hudis

For the current study, the researchers set out to assess the safety and efficacy of epoetin-alfa in a second randomization of the intense dose-dense arm (n=643). Patients then were assigned to receive epoetin-alfa (n=324) or no epoetin-alfa (n=319).

The investigators compared changes in hemoglobin levels, the percentage of patients who required a red blood cell transfusion and the incidence of thrombotic events.

Researchers also compared OS, RFS and intra-mammary relapse between the two arms.

Median follow-up was 62 months.

Researchers reported no decreases in hemoglobin levels among those assigned epoetin-alfa vs. a 2.20 g/dL decrease among controls (P<.001). In addition, epoetin-alfa significantly decreased the percentage of patients who required a red blood cell transfusion (12.8% vs. 28.1%; P<.0001).

However, the incidence for thrombotic events was 7% among those assigned epoetin-alfa vs. 3% among controls.

 

Chau T. Dang

Administration of epoetin-alfa did not affect OS, RFS or intramammary relapse.

“Overall, this study provides important evidence that erythropoiesis-stimulating agents may be safe in the curative treatment of cancer,” Chau T. Dang, MD, Clifford A. Hudis, MD, and Larry Norton, MD, all of the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center, wrote in an accompanying editorial. “At the same time, we must acknowledge that the data are insufficient to support the routine use of erythropoiesis-stimulating agents in this setting. The authors should be congratulated for addressing this important issue (with implications beyond breast cancer) as well as for providing additional evidence (in the parent trial) supporting the effectiveness of dose-dense scheduling.”

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Disclosure: The study was funded by Amgen, Bristol-Myers Squibb, Johnson & Johnson and Pharmacia.