title: Darbepoetin-alfa and intravenous iron administration after autologous hematopoietic stem cell transplantation: a prospective multicenter randomized trial.
abstract: We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell transplantation (HCT). Patients were randomized between no DA (Arm 1), DA 300 μg every 2 weeks starting on Day 28 after HCT (Arm 2), or DA plus i.v. iron 200 mg on Days 28, 42, and 56 (Arm 3). The proportion achieving complete hemoglobin (Hb) response within 18 weeks (primary end point) was 21% in Arm 1 (n = 24), 79% in Arm 2 (n = 25), and 100% in Arm 3 (n = 23; P < 0.0001). Erythropoietic response was shown to be significantly higher in Arm 3 (n = 46) than in Arm 2 (n = 50; P = 0.008), resulting in lower DA use, reduced drug costs, and improved quality of life scores, but the effect on transfusions was not significant. In multivariate analysis, DA administration (P < 0.0001), i.v. iron administration (P = 0.0010), high baseline Hb (P < 0.0001), and low baseline creatinine (P = 0.0458) were independently associated with faster achievement of complete Hb response. In conclusion, DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post-transplant. I.v. iron sucrose further improves erythroid recovery.
authors.affiliation: Department of Medicine, Division of Hematology, CHU of Liège, University of Liège, Liège, Belgium; Giga-Research, University of Liège, Liège, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Beguin
authors.forename: Johan
authors.initials: J
authors.lastname: Maertens
authors.forename: Bernard
authors.initials: B
authors.lastname: De Prijck
authors.forename: Rik
authors.initials: R
authors.lastname: Schots
authors.forename: Laurence
authors.initials: L
authors.lastname: Seidel
authors.forename: Christophe
authors.initials: C
authors.lastname: Bonnet
authors.forename: Kaoutar
authors.initials: K
authors.lastname: Hafraoui
authors.forename: Evelyne
authors.initials: E
authors.lastname: Willems
authors.forename: Gaetan
authors.initials: G
authors.lastname: Vanstraelen
authors.forename: Sophie
authors.initials: S
authors.lastname: Servais
authors.forename: Aurélie
authors.initials: A
authors.lastname: Jaspers
authors.forename: Georges
authors.initials: G
authors.lastname: Fillet
authors.forename: Frederic
authors.initials: F
authors.lastname: Baron
mesh_terms: D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology / Q000628:therapy; D001803:Blood Transfusion; D003131:Combined Modality Therapy; D000068256:Darbepoetin alfa; D004359:Drug Therapy, Combination; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008223:Lymphoma / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000601:surgery; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology / Q000628:therapy; D011788:Quality of Life; D014168:Transferrin / Q000032:analysis; D019172:Transplantation Conditioning / Q000009:adverse effects; D014182:Transplantation, Autologous
chemical_list: D005290:Ferric Compounds; D014168:Transferrin; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid