ArticlesErythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial
Introduction
The benefits of radiotherapy for patients with cancer diminish when anaemia is present.1 Correction of anaemia has been suggested to reverse this haemoglobin effect,2 thereby improving cancer control. Recombinant human erythropoietin can correct anaemia3, 4, 5 and improve quality of life in anaemic patients with cancer.6, 7 Furthermore, preclinical data suggest that erythropoietin increases the radiosensitivity of tumours8, 9 and might improve the clinical efficacy of radiation10 and chemotherapy.11 However, the potential of erythropoietin to improve cancer outcomes has not been established. Therefore, we investigated whether epoetin β could improve cancer control and survival of patients irradiated for head and neck cancer.
Section snippets
Patients
We enrolled patients between March, 1997, and April, 2001. Patients older than 18 years with histologically proven squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx who were scheduled to undergo definitive treatment with radiotherapy or postoperative radiotherapy for advanced disease (T3, T4, or nodal involvement) qualified for the study. Further eligibility criteria were haemoglobin concentration lower than 120 g/L for women or lower than 130 g/L for men, and a
Results
We enrolled 351 patients in 23 centres in Austria, France, Germany, and Switzerland. The last patient entered the study in April, 2001. At that time the sponsor decided to omit the scheduled second interim analysis because the statistical penalty was deemed to be too high and changes in overall conduct of the study were not expected. The data were unmasked at the end of November, 2002, analyses finished in April, 2003, and results were presented to the investigators in July, 2003. Authors
Discussion
Despite a reliable rise in haemoglobin concentrations, we saw no benefit for locoregional progression-free survival, locoregional progression, or survival. On the contrary, patients given placebo fared significantly better than those given epoetin β. A contribution of study design or conduct to this unexpected finding is unlikely. Centre performance, data collection, validation, and processing followed good clinical practice guidelines, and adherence to study-drug administration and to
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