News Release

Cancer patient mortality increased by anemia treatments

Peer-Reviewed Publication

The Lancet_DELETED

Agents used to treat anaemia in cancer patients, that work by stimulating red blood cell production, also increase mortality. The increased risk of death associated with these drugs should be balanced against their benefits in cancer patients. These are the conclusions of an Article in this week's edition of The Lancet, written by Dr Julia Bohlius, University of Bern, Switzerland, and Professor Andreas Engert, University of Cologne, Germany, and colleagues.

These drugs, called erythropoiesis-stimulating agents (or ESAs), reduce the need for red blood cell transfusions and could improve quality of life for patients with cancer. However, they have been reported to increase the risk of heart attack and stroke, and might also stimulate tumour growth. Uncertainty remains about whether and how these drugs affect survival; their safety has been discussed repeatedly at hearings of the US Food and Drug Administration and the European Medicines Agency. The authors did a meta-analysis of 53 cancer trials featuring almost 14,000 patients to establish the effect of ESAs on mortality. They assessed mortality during the active study period* and during the longest available follow-up.

The researchers found that 1530 patients died during the active study period and 4933 died overall. ESAs were associated with a relative increase in mortality during the active study period of 17%. When an analysis was done of only cancer patients receiving chemotherapy (38 trials, 10,441 patients), the relative increase in mortality attributable to ESAs was 10%. The type of anticancer treatment given did not make a difference to outcomes.

The authors say: "The findings of this individual patient data meta-analysis show that erythropoiesis-stimulating agents increase mortality in all patients with cancer, and a similar increase might exist in patients on chemotherapy... In clinical practice, the increased risks of death and thromboembolic events should be balanced against the benefits of treatment with erythropoiesis-stimulating agents, taking into account each patient's clinical circumstances and preferences. More data are needed for the effect of these drugs on quality of life and tumour progression, and meta-analyses similar to this one will address these questions."

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Dr Julia Bohlius, University of Bern, Switzerland T) +41-31-631 3510 E) jbohlius@ispm.unibe.ch

Professor Andreas Engert, University of Cologne, Germany T) +49-221-478-5933 E) a.engert@uni-koeln.de

For full Article, please see: http://press.thelancet.com/esas.pdf

Note to editors: *active study period means the period actually receiving the drug plus the four weeks immediately after


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