BACKGROUND: Epoetin-b is used to treat patients with cancer undergoing chemotherapy to alleviate the symptoms of anaemia, reduce the risk of blood transfusions and improve quality of life (QoL). METHODS: This meta-analysis of all 12 randomised, controlled studies of epoetin-b evaluated the impact of therapy at different Hb-initiation levels and to different target Hb levels on overall survival, tumour progression and thromboembolic events (TEE). An analysis of risk factors pre-disposing patients to TEEs under epoetin-b therapy was also performed. A total of 2297 patients are included in the analysis. RESULTS: Analyses based on various Hb-initiation levels indicate no detrimental impact on survival (HR 0.99; 95% CI 0.70, 1.40) and a favourable impact on disease progression (HR 0.73; 95% CI 0.57, 0.94) when epoetin-b was used within its licensed indication (Hb initiation p10 g dl À1 ) or the EORTC recommended level of 11 g dl À1 . An increased risk of TEEs is seen for all Hb-initiation level strata and a detrimental impact on survival is seen when initiating epoetin-b therapy at Hb levels 411 g dl À1 . We observe no association between high target Hb levels (X13 g dl À1 ) and an increased risk of mortality, disease progression or TEEs with epoetin-b compared with control. CONCLUSION: The results of this analysis indicate that epoetin-b therapy has no detrimental impact on survival or tumour progression when initiated at Hb levels up to 11 g dl À1 . Furthermore, there is no evidence to suggest that high Hb values achieved during epoetin-b therapy are associated with an increased mortality, disease progression or TEE rate.