Red blood cell transfusion and not epoetin alfa (EPO) should be the preferred approach in treating patients with metastatic breast cancer and anemia, according to a study published in the Journal of Clinical Oncology.1
Investigators conducted an open-label, noninferiority study to determine the impact of EPO on tumor outcomes in patients with anemia receiving chemotherapy for metastatic breast cancer.
The study’s primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, time to tumor progression, overall response rate, red blood cell transfusions, and thrombotic vascular events.
A total of 2098 women with hemoglobin ≤ 11.0 g/dL receiving first- or second-line chemotherapy were randomly assigned to receive either EPO 40 000 IU subcutaneously once weekly or best standard of care.
Results showed that overall the study did not meet noninferiority criteria.
Median PFS based on investigator-determined disease progression (PD) was 7.4 months in both groups (HR, 1.089; 95% CI, 0.988 – 1.200).
Median PFS per independent review committee determined PD was 7.6 months in both groups (HR, 1.028; 95% CI, 0.922 – 1.146). Median overall survival after 1337 deaths was 17.2 months in the EPO arm and 17.4 months in the standard of care arm (HR, 1.057; 95% CI, 0.949 – 1.177); median time to tumor progression was 7.5 months in both groups; and overall response rate was 50% vs 51%, respectively (odds ratio, 0.950; 95% CI, 0.799 – 1.130).
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Red blood cell transfusions occurred more commonly in the standard of care arm (11.4% vs 5.8% EPO; P < .001). Thrombotic vascular events occurred in 2.8% of patients in the EPO arm vs 1.4% in the standard of care arm (P = .038).
- Leyland-Jones B, Bondarenko I, Nemsadze G, et al. A randomized, open-label, multicenter, phase III study of epoetin alfa versus best standard of care in anemic patients with metastatic breast cancer receiving standard chemotherapy [published online ahead of print February 8, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.63.5649.