The presence of anaemia in patients with
cancer is correlated with poor clinical outcome, a reduced tumour response to anticancer
therapy and an increased risk of mortality. This observation has led to speculation as to whether treatment of anaemia can enhance survival rates. The majority of studies have suggested that erythropoietic
therapy either does not change or improves disease-free and/or overall survival. Only two studies, one in
breast cancer and the other in
head and neck cancer, both of which used epoetin outside its approved indications, have observed a decrease in survival in epoetin-treated patients compared with controls. Methodological issues and baseline imbalances between groups in prognostic factors for survival that may have favoured placebo treatment have complicated the interpretation of these studies. In contrast, a Cochrane meta-analysis of randomised, controlled trials of epoetin in anaemic patients with
cancer that reported survival identified 19 trials up to the end of 2001 with 2,865 patients. This meta-analysis reported a hazard ratio for overall survival of 0.81 (95% CI 0.67-0.99) for adjusted data and a hazard ratio of 0.84 (95% CI 0.69-1.02) for unadjusted data. A recent meta-analysis of nine randomised, controlled trials of
epoetin beta (n = 1,413) suggests that use of this
therapy is associated with a reduced risk of tumour progression. This meta-analysis also showed that no association existed between the risk of overall mortality or thromboembolic mortality and
epoetin beta therapy. These results suggest that treatment of anaemic patients with
cancer with
epoetin beta is effective and safe.