Stephan Thomé, MD
In patients with cancer-associated anemia, do erythropoiesis-stimulating agents (ESAs) increase mortality and venous thromboembolism (VTE)?
Studies selected evaluated ESAs (erythropoietin and darbepoetin) in patients with cancer and anemia. Outcomes were mortality and VTE.
MEDLINE and EMBASE/Excerpta Medica (Apr 2005 to Jan 2008); a previous Cochrane review* (studies published between 1985 and Apr 2005); Web sites of the US Food and Drug Administration (FDA) (Oncologic Drug Advisory Committee 2007 meeting) and ESA manufacturers; and reports by health authorities and at national conferences were searched for phase 3 trials. 54 trials met the selection criteria: 51 reported survival (n = 13 611); 38 reported VTE (n = 8172). 43 trials evaluated epoetin-α or β (n = 9033), and 11 evaluated darbepoetin (n = 4733). Duration of treatment ranged from 6 to 52 weeks.
Meta-analysis showed that ESAs increased risk for VTE (Table) and mortality (hazard ratio [HR] 1.10, 95% CI 1.01 to 1.20) more than control treatment or placebo. Subgroup analyses for mortality showed no heterogeneity of effect (P = 0.13) between trials of patients with treatment-related anemia (45 trials, n = 11 522, HR 1.09, CI 0.99 to 1.19) and those of patients with cancer-related anemia (6 trials, n = 2089, HR 1.29, CI 1.00 to 1.67).
Erythropoiesis-stimulating agents increase mortality and venous thromboembolism in patients with cancer and anemia.
Erythropoiesis-stimulating agents vs placebo or control for anemia in patients with cancer*
*VTE = venous thromboembolism; other abbreviations defined in Glossary. RRI, NNH, and CI calculated from data in article based on a random-effects model.
Thomé S. Review: Erythropoiesis-stimulating agents increase mortality and venous thromboembolism in cancer-associated anemia. Ann Intern Med. 2008;149:JC2–8. doi: 10.7326/0003-4819-149-4-200808190-02008
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Published: Ann Intern Med. 2008;149(4):JC2-8.
Hematology/Oncology, Red Cell Disorders, Venous Thromboembolism.
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