In February 2007, new concerns surfaced over the safety of agents that stimulate erythropoiesis when used to treat anaemia in patients with cancer. These concerns quickly gained the attention of the oncology community and the popular press. Most major newspapers carried this story1 because of the widespread clinical use of these agents and the high volume of advertising by the drugs' corporate sponsors aimed directly at the consumer.2

Safety concerns relate to the possibility that erythropoiesis stimulating agents are associated with increased tumour growth and worse survival in some patients with cancer. On 9 March 2007, a black box warning was added to the labelling of darbepoetin alfa and epoetin alfa in the United States. This instructed doctors to use the lowest dose possible to avoid red blood cell transfusions, and not to allow haemoglobin concentrations to exceed 120 g/l.3 The Food and Drug Administration has announced a special meeting of the Oncology Drugs Advisory Committee on 10 May 2007 to discuss this matter further.

Both randomised and open label trials have shown that patients with anaemia associated with cancer chemotherapy who are treated with erythropoiesis stimulating agents need fewer transfusions, have higher haemoglobin concentrations, and possibly have higher quality of life …