Epoetin-beta is used to treat patients with metastatic cancer undergoing chemotherapy to alleviate the symptoms of anaemia, reduce the risk of blood transfusions and improve quality of life. This meta-analysis of 12 randomised, controlled studies evaluated the impact of epoetin-beta on overall survival, tumour progression and thromboembolic events (TEEs). A total of 2297 patients were included in the analysis (epoetin-beta, n=1244; control, n=1053; 65% solid and 35% nonmyeloid haematological malignancies). A prespecified subgroup analysis assessed the effects in patients with a baseline Hb<or=11 g dl(-1), corresponding to current European Organisation for Research and Treatment of Cancer (EORTC) guidelines. No statistically significant effect on mortality was observed with epoetin-beta vs control, both overall (hazard ratio (HR)=1.13; 95% CI: 0.87, 1.46; P=0.355) and in patients with baseline Hb<or=11 g dl(-1) (HR=1.09; 95% CI: 0.80, 1.47; P=0.579). A trend for a beneficial effect on tumour progression was seen overall (HR=0.85; 95% CI: 0.72, 1.01; P=0.072) and in patients with an Hb<or=11 g dl(-1) (HR=0.80; 95% CI: 0.65, 0.99; P=0.041). An increased frequency of TEEs was seen with epoetin-beta vs control (7 vs 4% of patients); however, TEEs-related mortality was similar in both groups (1% each). The results of this meta-analysis indicate that when used within current EORTC treatment guidelines, epoetin-beta has no negative impact on survival, tumour progression or TEEs-related mortality.