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2012 HSR&D/QUERI National Conference Abstract

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2012 National Meeting

1083 — Trends in Anemia Treatment in Cancer, 2002 – 2009

Stroupe KTTarlov ELee TAWeichle TW, and Zhang QL, Hines VA Hospital; Michaelis LC, Loyola University Chicago; Ozer H, University of Illinois at Chicago; Browning MM, and Hynes DM, Hines VA Hospital;

The use of erythropoiesis-stimulating agents (ESAs) has proven effective in reducing the need for blood transfusions to manage anemia in cancer patients. However, growing concerns about adverse impacts of ESAs in cancer patients led to an FDA-mandated change in product labeling in 2007. The revised labeling included a new warning: ESAs should be given to cancer patients only to maintain a hemoglobin (Hb) level sufficient to avoid transfusion and never beyond 12g/dL. We examined shifts in the Hb level triggering ESA therapy in relation to this policy change among cancer patients undergoing chemotherapy in VA.

We used national VA databases to conduct a retrospective study of Veterans diagnosed from 2002 to 2009 who received chemotherapy within 12 months of their cancer diagnosis. Multivariable regression analyses were used to evaluate the trigger Hb level before and after the March 2007 FDA-mandated labeling change. All models were estimated with robust (sandwich) standard errors to accommodate non-independence of patients within VA facilities.

Of the 7,748 cancer patients who received chemotherapy within 12 months of their cancer diagnosis, those treated with an ESA after the March 2007 FDA labeling change initiated therapy at an Hb level that was 0.67 g/dL (95% CI:-0.77 to -0.58) lower than those treated before the labeling change. Moreover, the decline in Hb levels at which ESA therapy was initiated began in 2006. The average predicted Hb level at ESA initiation fell from 10.52 g/dL (95% CI: 10.39 to 10.66) in early 2006 to 9.43 g/dL (95% CI: 9.23 to 9.63) by late 2009.

Hb levels triggering ESA treatment in VA cancer care declined markedly beginning in early 2006, well before the 2007 changes in product labeling. This suggests that earlier dissemination of research results, rather than product labeling changes, likely spurred shifts in use of ESAs for anemia management.

In an era of rapid approval of medications, the dissemination and appropriate adoption of post-approval safety data is of critical importance in building a safer and more nimble clinical environment. Additional research is warranted on the manner in which safety data are disseminated to practitioners prior to formal agency declarations.

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