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Meta-Analysis Shows Darbepoetin Alfa Treatment Improves Outcomes in Patients With Chemo-Induced Anemia: Presented at ASH

By Bruce Sylvester

ALTANTA, GA -- December 16, 2005 -- A meta-analysis of randomized placebo-controlled trials indicates that darbepoetin alfa treatment is associated with reduced risk of transfusion, improvements in hematological and hematopoietic outcomes, and reduced mortality in patients with chemotherapy-induced anemia.

Researchers reported the findings here on December 12^th at the 47^th Annual Meeting of the American Society of Hematology (ASH).

Previous studies have demonstrated the benefits of erythropoiesis-stimulating proteins for increasing hemoglobin levels and reducing the incidence of red blood cell transfusions in patients receiving chemotherapy for cancer treatment. However, the effects of ESPs on overall survival have been inconclusive, according to researchers led by Nick Freemantle, PhD, professor of clinical epidemiology & biostatistics, University of Birmingham, Birmingham, United Kingdom.

The objective of the meta-analysis was to look at studies with identical methodology to that reported in another meta-analysis (Bohlius et al. Cochrane Database Syst Rev. 2002;(4):CD003189. Review), but to also include trials of darbepoetin alfa, which were not part of the Bohlius review.

Dr. Freemantle and colleagues included in their meta-analysis only trials that enrolled patient populations with chemotherapy-induced anemia. The meta-analysis included 4 trials with a total of 759 subjects.

The analysis demonstrated that darbepoetin alfa significantly reduced the risk of receiving a RBC transfusion (relative risk [RR] 0.69; 95% CI 0.59-0.81; P < .0001). Patients treated with darbepoetin alfa were significantly more likely to have a hematological response (RR 3.30; 95% CI 2.53-4.32; P < .0001) and a hematopoietic response (RR 2.64; 95% CI 2.17-3.21; P < .0001).

Darbepoetin alfa did not appear to have a negative impact on survival in the pooled results (hazard ratio [HR] 0.95; 95% CI 0.77-1.16; P = .62).

When the meta-analysis included all of the nondarbepoetin trials combined with the darbepoetin alfa trials, the overall HR was 0.88 (95% CI: 0.76-1.01).

"The results of this meta-analysis of randomized placebo-controlled trials demonstrate that darbepoetin alfa treatment is associated with reduced risk of transfusion and improved hematological and hematopoietic responses and negative effect on survival in patients with cancer receiving chemotherapy is unlikely," the researchers concluded.

The results are consistent with the conclusions of the Cochrane meta-analysis, they added.

Amgen, of Cambridge, UK, funded the study.


[Presentation title: Impact of Darbepoetin Alfa on Transfusion, Hemoglobin Response, and Survival in Cancer Patients With Chemotherapy-Induced Anemia: Results of a Meta-Analysis of Randomized, Placebo-Controlled Trials. Session Type: Abstract 3116]

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