PURPOSE: In 2007, growing concerns about adverse impacts of erythropoiesis-stimulating agents (ESAs) in cancer patients led to an FDA-mandated black box warning on product labeling, publication of revised clinical guidelines, and a Medicare coverage decision limiting ESA coverage. We examined ESA therapy in lung and colon cancer patients receiving chemotherapy in the VA from 2002 to 2008 to ascertain trends in and predictors of ESA use. METHODS: A retrospective study employed national VA databases to "observe" treatment for a 12-month period following diagnosis. Multivariable logistic regression analyses evaluated changes in ESA use following the FDA-mandated black box warning in March 2007 and examined trends in ESA administration between 2002 and 2008. RESULTS: Among 17,014 lung and 4,225 colon cancer patients, those treated after the March 2007 FDA decision had 65% (lung OR 0.35, CI(95%) 0.30-0.42) and 53% (colon OR 0.47, CI(95%) 0.36-0.63) reduced odds of ESA treatment compared to those treated before. Declines in predicted probabilities of ESA use began in 2006. The magnitude of the declines differed across age groups among colon patients (p = 0.01) and levels of hemoglobin among lung cancer patients (p = 0.04). CONCLUSIONS: Use of ESA treatment for anemia in VA cancer care declined markedly after 2005, well before the 2007 changes in product labeling and clinical guidelines. This suggests that earlier dissemination of research results had marked impacts on practice patterns with these agents.
PURPOSE: In 2007, growing concerns about adverse impacts of erythropoiesis-stimulating agents (ESAs) in cancerpatients led to an FDA-mandated black box warning on product labeling, publication of revised clinical guidelines, and a Medicare coverage decision limiting ESA coverage. We examined ESA therapy in lung and colon cancerpatients receiving chemotherapy in the VA from 2002 to 2008 to ascertain trends in and predictors of ESA use. METHODS: A retrospective study employed national VA databases to "observe" treatment for a 12-month period following diagnosis. Multivariable logistic regression analyses evaluated changes in ESA use following the FDA-mandated black box warning in March 2007 and examined trends in ESA administration between 2002 and 2008. RESULTS: Among 17,014 lung and 4,225 colon cancerpatients, those treated after the March 2007 FDA decision had 65% (lung OR 0.35, CI(95%) 0.30-0.42) and 53% (colon OR 0.47, CI(95%) 0.36-0.63) reduced odds of ESA treatment compared to those treated before. Declines in predicted probabilities of ESA use began in 2006. The magnitude of the declines differed across age groups among colonpatients (p = 0.01) and levels of hemoglobin among lung cancerpatients (p = 0.04). CONCLUSIONS: Use of ESA treatment for anemia in VA cancer care declined markedly after 2005, well before the 2007 changes in product labeling and clinical guidelines. This suggests that earlier dissemination of research results had marked impacts on practice patterns with these agents.
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