Hoskin, P. J., Robinson, M., Slevin, N., Morgan, D., Harrington, K., & Gaffney, C. (2009). Effect of epoetin alfa on survival and cancer treatment-related anemia and fatigue in patients receiving radical radiotherapy with curative intent for head and neck cancer. Journal of Clinical Oncology, 27, 5751–5756.

To evaluate the effect of epoetin alfa on local disease-free survival (DFS) (primary endpoint), overall survival, and cancer treatment-related anemia and fatigue (secondary endpoint).

Patients were randomized to one of the following three groups:

• Radiation and epoetin alfa 10,0000 units subcutaneously (subq) if hemoglobin (Hgb) was less than 15 g/dL
• Radiation and epoetin alfa 4,000 units subq if Hgb was less than 12.5 g/dL
• Radiation alone.

• The study included 300 patients (232 men, 68 women); 111 completed the study.
• Age ranged from 35 to 88 years.
• Patients were diagnosed with squamous cell head and neck cancer, stages I to III.
• Patients had a Hgb level less than 15 g/dL.

• Multisite
• United Kingdom

The study was a phase III, randomized, controlled trial.

• Functional Assessment of Cancer Therapy-Anemia (FACT-An)
• FACT-Head and Neck

Hgb increased from baseline with epoetin alfa. Median duration of local DFS (primary endpoint) was not statistically significant (hazard ratio = 1.04). The groups did not differ significantly in terms of DFS, overall survival, tumor outcomes, or cancer-related anemia or fatigue.

The addition of epoetin alfa did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in the head and neck cancer population.

• The study had low accrual.
• The degree of diagnostic severity, combined with the effects of radiation, may have minimized the potential benefit of epoetin alfa.

Epoetin alfa cannot be recommended for the treatment of cancer-related fatigue in the head and neck cancer population.