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Pooled analysis of individual patient-level data from all randomized, double-blind, placebo-controlled trials of darbepoetin alfa in the treatment of patients with chemotherapy-induced anemia
Journal of Clinical Oncology, 06/10/09
Ludwig H et al. - In a study to assess benefits and risks of erythropoiesis-stimulating agents (ESAs) in chemotherapy-induced anemia (CIA), there seemed to be no association between darbepoetin alfa (DA) and risk of death or disease progression in this meta-analysis of individual pt data from DA studies conducted in CIA, the approved indication for ESAs in oncology.
Methods- To assess the benefits and risks of ESAs in CIA, a pooled analysis was done of individual pt-level data from all randomized, double-blind, placebo-controlled trials in 2122 pts with CIA receiving DA (n=1200) or placebo (n=912).
- DA did not increase mortality and had no effect on progression-free survival (PFS) and disease progression, but increased the risk for thromboembolic events.
- Overall survival and PFS were not affected by baseline hemoglobin and seemed better in pts who achieved hemoglobin >12 or >13 g/dL.
- Transfusions and rates of hemoglobin increase (>1 g/dL in 14 days; >2 g/dL in 28 days) owing to transfusions were associated with an increased risk for death and disease progression in both treatment groups; in the absence of transfusions, rates of hemoglobin increase did not appear to increase risk for adverse outcomes.
- Compared with placebo, DA significantly reduced the risk of receiving 1 or more transfusions.
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