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.

DOI Link

Study Purpose

To evaluate the effects of treatment with epoetin alfa on anemia-related, patient-reported outcomes in women with breast cancer receiving myelotoxic chemotherapy.

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The study included 166 females (81 in the epoetin alfa group, 85 in the best supportive care group).
  • Mean patient age ranged from 53.3 to 54.3 years (mean range 27–77). 
  • Patients with breast cancer had a planned 12-week administration of chemotherapy.
  • Stage IV was the most common stage.

Setting

  • Multisite
  • Outpatient
  • Six European countries

Study Design

The study was a randomized, controlled phase IIIb trial.

Measurement Instruments/Methods

  • Functional Assessment of Cancer Therapy-Anemia (FACT-An)
  • Cancer Linear Analog Scale (CLAS) to assess patient-related outcomes

Results

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).

Conclusions

Epoetin alfa was well tolerated. Early administration in the treatment course attenuated deterioration in anemia-related, patient-reported outcomes.

Limitations

  • No actual direct fatigue measurement was used. 
  • A visual analog scale (VAS) was used for related measures, but no recognized definitive methods of measurement were used.

Nursing Implications

New U.S. Food and Drug Administration (FDA) guidelines exist for the administration of epoetin alfa.