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Randomized study of darbepoetin alfa as modifier of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC): Final outcome of the DAHANCA 10 trial.

6007 Background: The study aimed to evaluate if correction of low hemoglobin (Hb) levels by means of the erythropoietin stimulating agent: darbepoetin alpha (Aranesp) during radiotherapy (RT) improves outcome in patients with HNSCC. Following a planned interim analysis which showed inferiority of the experimental treatment, the trial was stopped in November 2006.


METHODS
Pts with HNSCC eligible for primary RT alone and with Hb values below 14.0 g/dl were randomized to receive Aranesp together with accelerated fractionated RT. Pts. were stratified according to gender, T and N staging, tumor site, and institution. Aranesp was given subcutaneously in a dose of 150 micrograms weekly during RT, or stopped earlier if the Hb exceeded 15.5 g/dl.


RESULTS
In total, 522 patients (of a planned intake of 600) were included at the time of the interim analysis. Of these 514 pts were eligible for analysis (255 pts treated with Aranesp and 259 pts in the control group) with a median follow up of 49 months. Among these, 201 developed a loco-regional failure (primary endpoint). There have been 238 deaths of which 176 are due to HNSCC. The patients were evenly distributed according to the stratification parameters (gender, T and N staging, tumor site, institution).Aranesp resulted in the expected increase in Hb in more than 81% of the patients. The compliance to Aranesp was good with no significant difference in serious (cardiovascular) adverse events (3% vs. 1%). Overall, the results showed a poorer outcome in 5-year loco-regional control (59% vs. 68% (p = 0.04, RR: 1.47 [1.14-1.94]) for the Aranesp vs. control arm. This was also seen for the endpoint of disease-free survival (37% vs. 47%, p = 0.02, RR: 1.32 [1.04-1.68]), whereas there was no significant difference in overall survival (40% vs. 51%, p = 0.16, RR: 1.20 [0.93-1.55]). There were no differences in radiation related morbidity. All univariate analyses were confirmed in a multivariate setting.


CONCLUSIONS
Correction of the Hb level with Aranesp in patients with HNSCC resulted in a significantly poorer tumor control after radiotherapy. The treatment principle was abandoned and the difference in outcome is being subjected to further examination. No significant financial relationships to disclose.