Anemia in cancer patients may be secondary to the disease or to the treatment. Concerns have been raised about the safety of erythropoiesis-stimulating agents (ESAs) for treating anemia in cancer patients, prompting a January 2008 US Food and Drug Administration (FDA) update to a previous boxed warning.  

Three recent reviews investigated the safety and efficacy of ESA use in cancer patients.  Although 2 large systematic reviews showed an increase in overall mortality risk, a third smaller review, and subgroups in the first 2, showed no differences in analyses limited to patients treated with ESAs  while on chemotherapy (level 2 [mid-level] evidence).   

A review of 53 trials with 13,933 patients showed a significant increase in overall mortality compared to control (11.3% vs. 10.6%, p < 0.05), but no significant difference in an analysis of 10,441 patients on chemotherapy from 38 trials (10.7% vs. 10.3%) (Lancet 2009 May 2;373(9674):1532). 

A second large review also showed a significant increase in overall mortality compared to control (13.6% vs. 13.1%, p < 0.05) in a meta-analysis of 28 trials with 6,525 patients.  However, there were no significant differences in mortality with ESAs in treatment of chemotherapy-induced anemia (risk ratio 1.04, not significant) in an analysis of 23 trials with 4,273 patients (CMAJ 2009 May 26;180(11):E62 full-text).

The third review was a pooled analysis of individual patient data from 6 trials evaluating darbepoetin alfa with 2,112 chemotherapy patients and showed no significant differences in overall survival, progression-free survival or disease progression (J Clin Oncol 2009 Jun 10;27(17):2838). 

In all 3 reviews, erythropoiesis-stimulating agents were associated with significant reductions in the risk of transfusions. 

For more information, see the Anemia of chronic disease topic in DynaMed.