title: Impact of epoetin-beta on survival of patients with lymphoproliferative malignancies: long-term follow up of a large randomized study.
abstract: 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.
authors.affiliation: Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. anders.osterborg@kus.se
authors.forename: Anders
authors.initials: A
authors.lastname: Osterborg
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Brandberg
authors.forename: Michael
authors.initials: M
authors.lastname: Hedenus
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008232:Lymphoproliferative Disorders / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D015996:Survival Rate; D017211:Treatment Failure
chemical_list: D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa