Early vs. late treatment with darbepoetin alfa in patients with genitourinary tumors during chemotherapy
18583 Background: Anemia is a common complication in patients who receive anticancer therapy. We evaluated the efficacy of darbepoetin alfa in early vs. late treatment in patients with genitourinary tumors undergoing chemotherapy. We wanted to investigate whether an early onset of treatment with darbepoetin alfa reduces frequency of red blood cell transfusion and increases patients’ QoL. Methods: Patients on chemotherapeutic treatment for a urogenital neoplasia and a hemoglobin between 10–12 g/dl were randomized between an immediate start of treatment with darbepoetin alfa 150 μg sc weekly (group A) and a Hb below 10 g/dl or clinical symptoms (group B). Results: 52 patients out of 68 (76.5%) completed the trial, 7/40 patients (17%) in group A and 9/28 patients (32%) in group B withdraw from the study. An intent to treat analysis was performed and showed a significant superiority (p = 0.023, log-rank test) for the early treatment. In group A, only 12.5% of patients (5/40) received at least one red blood cell transfusion compared to group B, where 39% of the patients (11/28) received a transfusion. In group A the mean Hb level increased steadily, starting with a baseline value of 11.0 g/dl. In week 21 a mean Hb level of 12.8 g/dl was reached, resulting in an overall increase in Hb of 1.8 g/dl. In group B, which had a comparable baseline Hb level of 10.9 g/dl, the mean Hb value decreased initially during the first 4 weeks to 10.0 g/dl. In week 21 a level of 11.4 g/dl was reached, resulting in a total Hb-increase of 0.5 g/dl. When anemia treatment was initiated early, the mean Hb level always remained in the range of 11 to 13 g/dl from the beginning of the study, in the B group the mean level of 11 g/dl was first achieved after 12 weeks. 35% in group A compared to 54% in group B (p = 0.13) experienced a dose doubling. The mean values (EORTC-QLQ-C30) of all symptom scales in group A were markedly below those in group B with the highest difference for dyspnea, 29.1 points (p < 0.001). Conclusions: Early treatment with darbepoetin alfa in patients with urogenital cancer results in optimal hemoglobin levels according to EORTC guidelines and consequently in a reduction of red blood cells transfusion. Furthermore, in patients with earlier initiation of treatment a clinically significant improvement of dyspnea can be observed. [Table: see text]