title: Phase II study of three dose levels of continuous erythropoietin receptor activator (C.E.R.A.) in anaemic patients with aggressive non-Hodgkin's lymphoma receiving combination chemotherapy.
abstract: Anaemia is a common complication in the treatment of patients with aggressive non-Hodgkin lymphoma (NHL), but there are no published data on the effect of erythropoiesis-stimulating agents in such patients. This is the first open-label, phase II, dose-finding study to evaluate the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.). Ninety-three anaemic patients with aggressive NHL who were receiving chemotherapy (including many advanced NHL, heavily pretreated patients) were randomised to receive 2.1, 4.2 or 6.3 microg/kg C.E.R.A. subcutaneously once every 3 weeks for 12 weeks. Haematopoietic response was achieved in 45%, 57% and 65% of patients at the respective dose level. During weeks 5-13, the mean haemoglobin changes from baseline in the intent-to-treat population were increases of 0.2, 2.4, and 5.7 g/l in the 2.1, 4.2, and 6.3 microg/kg treatment groups, respectively, and 4.4, 5.7 and 6.8 g/l in the per-protocol population at the respective dose levels. C.E.R.A. was generally well tolerated in all three groups. C.E.R.A. appeared to have dose-dependent clinical activity in most anaemic patients with aggressive NHL who were receiving chemotherapy.
authors.affiliation: Departments of Oncology and Haematology, Karolinska University Hospital, Stockholm, Sweden. anders.osterborg@karolinska.se
authors.forename: Anders
authors.initials: A
authors.lastname: Osterborg
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Steegmann
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
authors.forename: Stephen
authors.initials: S
authors.lastname: Couban
authors.forename: Jiri
authors.initials: J
authors.lastname: Mayer
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Eid
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D011092:Polyethylene Glycols