Impact of epoetin-beta on survival of patients with lymphoproliferative malignancies: long-term follow up of a large randomized study.

Recent studies have suggested that epoetin treatment of anaemia may influence the survival of patients with cancer. We conducted an analysis of long-term survival in patients with lymphoproliferative malignancies treated with epoetin-beta or placebo in a large-scale study. This was a randomized, double-blind trial in which patients with transfusion-dependent anaemia and lymphoproliferative malignancy received epoetin-beta 150 IU/kg or placebo three times weekly for 16 weeks. Long-term survival data were analysed by standard Kaplan-Meier methods and differences between groups were assessed using a log-rank test. The intention-to-treat population consisted of 343 patients (epoetin-beta, n = 170; placebo, n = 173). There were no major differences between the two treatment groups in demographic or clinical characteristics/prognostic factors. A total of 110 (65%) patients died in the epoetin-beta group (censored, n = 60) and 109 (63%) died in the placebo group (censored, n = 64) up to the end of long-term follow up. Kaplan-Meier curves for survival were similar in both groups. Median survival was 17 months with epoetin-beta and 18 months with placebo. A log-rank test indicated no significant difference in survival (P = 0.76). This long-term follow up indicated that epoetin-beta has no significant effect on survival compared to placebo in anaemic patients with lymphoproliferative malignancies.