Impact of epoetin‐β on survival of patients with lymphoproliferative malignancies: long‐term follow up of a large randomized study*

Abstract

SummaryRecent 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-b 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-b 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-b, n ¼ 170; placebo, n ¼ 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-b group (censored, n ¼ 60) and 109 (63%) died in the placebo group (censored, n ¼ 64) up to the end of long-term follow up. KaplanMeier curves for survival were similar in both groups. Median survival was 17 months with epoetin-b and 18 months with placebo. A log-rank test indicated no significant difference in survival (P ¼ 0AE76). This long-term follow up indicated that epoetin-b has no significant effect on survival compared to placebo in anaemic patients with lymphoproliferative malignancies.

Effect of treatment with epoetin-β on survival, tumour progression and thromboembolic events in patients with cancer: an updated meta-analysis of 12 randomised controlled studies including 2301 patients

“…Other studies were, however, designed to assess the effects of epoetin-b on survival and/or disease progression (Henke et al, 2003;Aapro et al, 2008) or Hb response to treatment (Strauss et al, 2008). Long-term follow-up information, up to 60 months, was available for overall survival in four studies (Henke et al, 2003;Ö sterborg et al, 2005;Aapro et al, 2008;Strauss et al, 2008) and for tumour progression in three studies (Henke et al, 2003;Aapro et al, 2008;Strauss et al, 2008). All reported adverse events were also reviewed against a prespecified list of TEEs, the definition of which was consistently applied across all studies.…”

European Myeloma Network Guidelines for the Management of Multiple Myeloma-related Complications

“…[36][37][38][39][40] Predictors of response to ESAs include the ratio of observed to expected Hb (<0.9) and the preserved BM function, reflected by the platelet counts (>150x10 9 /L). 33,38,41 A systematic review of the use of ESAs in more than 20,000 cancer patients confirmed that their use reduced the relative risk of transfusions due to increase of erythroid responses, but there was evidence that ESAs increased mortality during ESA administration and thus decreased OS. 42 Although anemia is common in MM patients, no clear consensus exists as to the use and impact of ESAs on outcome in MM and randomized studies in MM patients are still limited.…”

Epoetin-β treatment in patients with cancer chemotherapy-induced anaemia: the impact of initial haemoglobin and target haemoglobin levels on survival, tumour progression and thromboembolic events

“…For the meta-analysis, this information was analysed retrospectively by reviewers blinded to treatment assignment. Four of the studies, which did evaluate the effects of epoetin-b on survival and/or disease progression (Henke et al, 2003;Ö sterborg et al, 2005;Aapro et al, 2008b) or response to treatment (Strauss et al, 2008) provided long-term (up to 60 months) follow-up information for overall survival or tumour progression. For the assessment of TEEs, all reported adverse events were reviewed against a pre-specified list of TEEs, which was applied consistently across all studies.…”

“…For these analyses, patients without events were censored at 4 weeks after the last entry in the administration record. A second set of analyses using only pooled patient data from the studies with long-term follow up in which all events were included in the analysis was performed for overall survival (Henke et al, 2003;Ö sterborg et al, 2005;Strauss et al, 2008;Aapro et al, 2008b) and time to progression (Henke et al, 2003;Strauss et al, 2008;Aapro et al, 2008b). In the study by Ö sterborg et al, 2005, patients were followed for survival but not for disease progression, therefore this study was excluded from the time to progression analyses.…”