Epoetin alfa had no effect on survival, tumor outcomes in head and neck cancers
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Adding epoetin alfa to radiotherapy had no effect on survival, tumor outcomes, anemia or fatigue for patients with head and neck cancers.
Patients with head and neck squamous cell carcinoma and hemoglobin less than 15 g/dL were recruited for a phase-3, multicenter, randomized, open-label trial in the United Kingdom (n=301). All patients underwent radiotherapy and half were assigned to epoetin alfa (Eprex, Ortho Biotech/Janssen-Cilag). Fifty-six patients in the control group and 55 in the epoetin alfa group completed five years of follow-up.
Despite an increase in hemoglobin with epoetin alfa, the median duration of local disease-free survival for the two groups was not significantly different (35.42 months vs. 31.47 months). Local disease-free survival remained similar between the groups during the follow-up period.
Median disease-free survival was 35.42 in the observation group vs. 30.13 months in the epoetin alfa group. As with local disease-free survival, Kaplan-Meier estimates showed no significant differences between the groups, and disease-free survival remained similar between groups throughout the five years.
Time to local disease recurrence and median OS were likewise similar between the two groups and remained so throughout the follow-up period.
The researchers also observed no differences in changes from baseline in scores for treatment-related anemia and fatigue on any subscale or overall score. There were no substantial correlations between hemoglobin or change in hemoglobin from baseline and anemia and fatigue scores.
Hoskin PJ. J Clin Oncol. 2009;doi:10.1200/JCO.2009.22.3693.