1.
Epoetin alfa in patients with advanced-stage Hodgkin's lymphoma: results of the randomized placebo-controlled GHSG HD15EPO trial
Engert A, Josting A, Haverkamp H, Villalobos M, Lohri A, Sökler M, Zijlstra J, Sturm I, Topp MS, Rank A, et al
Journal of Thrombosis and Haemostasis. 2010;28((13):):2239-45.
Abstract
PURPOSE To determine whether epoetin alfa reduces anemia-related fatigue, improves other aspects of health-related patient-recorded outcomes (PROs), reduces the number of RBC transfusions, and has an impact on freedom from treatment failure (FFTF) and overall survival (OS) in patients with advanced-stage Hodgkin's lymphoma (HL). PATIENTS AND METHODS The prospectively randomized HD15EPO study performed by the German Hodgkin Study Group investigated epoetin alfa administered at doses of 40,000 U weekly during and after chemotherapy (six to eight cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone [BEACOPP]) in a double-blind, placebo-controlled setting. The study accrued 1,379 patients, of whom 1,328 were assessable for safety, 1,303 were assessable for clinical outcome, and 930 were assessable for PROs. RESULTS PROs were not different in patients receiving placebo or epoetin alfa, both after the end of chemotherapy and 6 months thereafter. There was no difference between patients treated with epoetin alfa or placebo with respect to FFTF and OS. There were also no differences in the numbers of deaths, progressions, relapses, and thromboembolic events. The median number of RBC transfusions was reduced from four per patient in the placebo group to two per patient in the epoetin alfa group (P < . 001), with 27. 4% of patients needing no RBC transfusion in the placebo group compared with 36. 7% of patients in the epoetin alfa group (P < . 001). CONCLUSION Epoetin alfa administered at 40,000 U weekly parallel to BEACOPP chemotherapy was safe in patients with advanced-stage HL and reduced the number of RBC transfusions but had no impact on fatigue and other PRO domains.
2.
A prospectively randomized placebo-controlled trial of epoetin-alfa in patients with advanced-stage Hodgkin Lymphoma: final analysis of the GHSG HD15-EPO Trial
Engert A, Borchmann P, Fuchs M, Josting A, Haverkamp H, Diehl V
Blood. 2008;112((11):): Abstract No. 2598.
3.
Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial
Glossmann JP, Engert A, Wassmer G, Flechtner H, Ko Y, Rudolph C, Metzner B, Dörken B, Wiedenmann S, Diehl V, et al
Annals of Hematology. 2003;82((8):):469-75.
Abstract
The aim of the study was to investigate the effects of erythropoietin (epoetin beta) on red blood cell (RBC) transfusions, hemoglobin (Hb) levels, and quality of life (QOL) in patients with relapsed lymphoma treated with an aggressive sequential salvage chemotherapy (SSCT) regimen. Sixty patients with early or late relapsed Hodgkin's disease ( n=39) or first relapse of aggressive non-Hodgkin's lymphoma ( n=21) were randomized to receive epoetin beta 10,000 IE subcutaneously three times a week or no epoetin during salvage chemotherapy. Patients in both study arms received two cycles of DHAP (dexamethasone, high-dose cytarabine, cisplatin); patients in partial remission (PR) or complete remission (CR) then received cyclophosphamide, followed by peripheral blood stem cell (PBSC) harvest, methotrexate plus vincristine, and etoposide. The final myeloablative course was BEAM (carmustine, etoposide, cytarabine, and melphalan) followed by autologous stem cell support. The primary endpoint of the study was the number of RBC units needed during SSCT. In addition, Hb levels and QOL were measured. The mean number of RBC units given in the epoetin beta arm was 4. 5 compared to 8. 3 in the control arm ( P=0. 0134). The mean Hb levels during therapy were 10. 4 g/dl in the epoetin beta arm and 9. 7 g/dl in the control ( P=0. 018). From baseline until BEAM therapy QOL (EORTC QLQ C30) and fatigue (MFI) assessment showed little QOL worsening or stable levels in both arms with a steeper increase of fatigue levels in the control group. Patients with relapsed lymphoma undergoing aggressive chemotherapy and stem cell support benefited from epoetin beta therapy, with a decrease of RBC transfusion requirements and lower rise of fatigue levels.
4.
Erythropoietin is effective in patients with relapsed lymphoma treated with the Cologne high-dose sequential chemotherapy regimen
Glossmann J, Engert A, Wassmer G, Flechtner H, Ko Y, Rudolph C, Illiger J, Dörken B, Wiedenmann S, Diehl V, et al
Bone Marrow Transplantation. 2002;29((Suppl S2):):S92.. Abstract No. P450.
5.
Decreased transfusion requirements using epoetin beta in patients with relapsed lymphoma treated with the cologne high-dose sequential chemotherapy regimen prior to autologous stem cell support
Glossmann JPG, Engert A, Wassmer G, Flechtner H, Ko Y, Rudolph C, Illiger HJ, Doerken B, Wiedenmann S, Diehl V, et al
Haematologica. 2002;87((Suppl 1):): Abstract No. 0163.
6.
Effects of recombinant human erythropoietin on transfusion requirements in patients with relapsed lymphoma treated with aggressive high dose sequential chemotherapy
Glossmann JP, Engert A, Wassmer G, Flechtner H, Ko Y, Rudolph C, Illiger HJ, Dorken B, Wiedenmann S, Diehl V, et al
Blood. 2002;100((11):):774a.. Abstract No. 3061.