Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.
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.
Glossmann
J-P
JP
First Department of Internal Medicine, University Hospital Cologne, Joseph-Stelzmann-Strasse 9, 50931, Cologne, Germany. jan-peter.glossmann@uni-koeln.de.
Engert
A
A
First Department of Internal Medicine, University Hospital Cologne, Joseph-Stelzmann-Strasse 9, 50931, Cologne, Germany.
Wassmer
G
G
IMSIE, University Hospital Cologne, Cologne, Germany.
Flechtner
H
H
Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, University Hospital Cologne, Cologne, Germany.
Ko
Y
Y
Poliklinik Bonn, Bonn, Germany.
Rudolph
C
C
II. Medizinische Klinik, CTK Cottbus, Cottbus, Germany.
Metzner
B
B
Klinikum Oldenburg, Oldenburg, Germany.
Dörken
B
B
Virchow-Hospital, Humboldt University Berlin, Berlin, Germany.
Wiedenmann
S
S
First Department of Internal Medicine, University Hospital Cologne, Joseph-Stelzmann-Strasse 9, 50931, Cologne, Germany.
Diehl
V
V
First Department of Internal Medicine, University Hospital Cologne, Joseph-Stelzmann-Strasse 9, 50931, Cologne, Germany.
Josting
A
A
First Department of Internal Medicine, University Hospital Cologne, Joseph-Stelzmann-Strasse 9, 50931, Cologne, Germany.
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011788:Quality of Life; D011994:Recombinant Proteins; D016879:Salvage Therapy
D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin