Recombinant human erythropoietin in transfusion-dependent anemic patients with multiple myeloma and non-Hodgkin's lymphoma--a randomized multicenter study. The European Study Group of Erythropoietin (Epoetin Beta) Treatment in Multiple Myeloma and Non-Hodgkin's Lymphoma

Abstract

One hundred twenty-one anemic, transfusion-dependent patients with multiple myeloma (MM) or low-grade non-Hodgkin's lymphoma (NHL) were randomly allocated to receive (a) recombinant human erythropoietin (rhEPO) 10,000 U/d subcutaneously 7 days a week (fixed dose group) (n = 38), or (b) rhEPO 2,000 U/d subcutaneously for 8 weeks followed by step- wise escalation of the rhEPO dose (titration group) (n = 44), or (c) no rhEPO therapy (control group) (n = 39). The total treatment period was 24 weeks. There were no differences between the three groups with regard to baseline clinical, demographic, or health status measures. The cumulative response frequency, defined as elimination of the transfusion need in combination with an increase in the hemoglobin concentration by >20 g/L, was 60% in both rhEPO treatment groups and 24% in the control group (P = .01 and .02, respectively, log rank test). For patients in the titration group the response rate on the first dose level (2,000 U/d) was only 14%. Cox's univariate regression analysis revealed that an inadequately low endogenous erythropoietin concentration in relation to the degree of anemia and a baseline platelet concentration > or = 100 x 10(9)/L were significant predictors for response to rhEPO therapy (P < .01). Multivariate regression analysis showed that relative erythropoietin concentration was the most important factor and the platelet count had no additional influence on response. Treatment with rhEPO was well tolerated. We conclude that treatment with rhEPO may be indicated in anemic MM and NHL patients with a relative erythropoietin deficiency. An initial dose of 5,000 U/d subcutaneously may be recommended.

Prior Red Blood Cell Transfusions in Cancer Patients Increase the Risk of Subsequent Transfusions With or Without Recombinant Human Erythropoietin Management

“…More recent research with rHuEPO has focused on the identification of variables that are predictive of future response to therapy. These include baseline variables such as serum ferritin, serum erythropoietin levels, and baseline Hb levels, as well as early response variables [26][27][28][29]. However, results have yet to demonstrate clinical sensitivity and specificity in prognosticating response to rHuEPO [30].…”

Once‐weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production

“…Based on a systematic review of the literature, the recent guidelines of the American Society of Clinical Oncology and the American Society of Hematology (Rizzo et al, 2002) recommend use of epoetin as a treatment option for patients with chemotherapy-associated anaemia with a haemoglobin concentration below 10 g/dl, and advise subcutaneous administration thrice weekly at a starting dose of 150 U/kg. Three European trials in the last few years have studied the efficacy of epoetin beta in anaemic patients with multiple myeloma, non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, most of whom were receiving concurrent or recent chemotherapy for their disease (Cazzola et al, 1995;Osterborg et al, 1996Osterborg et al, , 2002. Despite considerable differences in their designs, all three studies showed that defective endogenous Epo production was a major predictor of response to treatment.…”

Management of Cancer-Related Anemia with Erythropoietic Agents: Doubts, Certainties, and Concerns

“…In patients with solid tumors, the adverse event profiles were similar in the rHuEPO and placebo groups, though a few more cases of deep vein thrombosis occurred in the rHuEPO group. In six trials in patients with anemia due to an underlying hematologic malignancy [68][69][70][71][72][73], there was a statistically significant higher rate of hypertension (10% versus 1%; p = .011) and a nonsignificantly higher rate of thromboembolic events (3% versus 0%; p = .55) among rHuEPO-treated patients [11]. The incidences of adverse events were similar in three community-based, open-label trials [38][39][40] and generally lower than those reported in the comparative trials.…”