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December 24 2008

Erythropoiesis-Stimulating Agents in the Treatment of Cancer-Associated Anemia—Reply

JAMA. 2008;300(24):2854-2857. doi:10.1001/jama.2008.870

In Reply: The original intent of our analysis was to evaluate risks for VTE when cancer patients received ESAs vs placebo/control.1 At the time we initiated our study, the most recent data had been reported by the Cochrane Collaboration in 2006.2 In response to a 2007 report of the FDA ODAC that ESA administration to cancer patients was associated with increased mortality risks,3 we evaluated mortality outcomes. As indicated in our JAMA article, the 2006 Cochrane review was used as the primary data source and was supplemented by trials reported more recently (ie, from the end of the review period for the Cochrane review [April 2005] to January 17, 2008), as well as by trials presented at the 2007 ODAC meeting. However, we erroneously interpreted the Cochrane review as including trials administering iron to the ESA group but not to the control group and therefore included these trials in our analysis. As shown in Figure 1 of our JAMA article, we identified 13 trials for the survival analysis and 5 trials for the VTE analysis that were not included in the Cochrane review; we did not include updated mortality data for the studies that had been identified in the 2006 Cochrane review. There were no other specific eligibility criteria or preplanned subgroup analyses.

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