title: Thromboembolic events in patients with myelodysplastic syndrome receiving thalidomide in combination with darbepoietin-alpha.
abstract: A phase II trial was conducted to explore the efficacy and tolerability of combining thalidomide (100 mg/d p.o.) with an erythropoietic growth factor (darbepoietin-alpha 2.25 micro g/kg/d s.c.) in patients with low-to-intermediate-risk myelodysplastic syndromes (MDS). However, the trial had to be discontinued early because of an unexpectedly high incidence of thromboembolic events. Of the first seven patients enrolled, two developed deep-vein thrombosis and one died of massive pulmonary embolism. We concluded that thalidomide might significantly increase the thromboembolic risk of erythropoietic proteins in MDS patients. Careful clinical surveillance and thrombosis prophylaxis (heparin or oral anticoagulation) should be considered for MDS patients undergoing combined treatment with thalidomide and erythropoietic growth factors.
authors.affiliation: Division of Haematology and Oncology, Innsbruck University Hospital, Anichstrasse 35, A-6020 Innsbruck, Austria. michael.steurer@uibk.ac.at
authors.forename: Michael
authors.initials: M
authors.lastname: Steurer
authors.forename: Irene
authors.initials: I
authors.lastname: Sudmeier
authors.forename: Reinhard
authors.initials: R
authors.lastname: Stauder
authors.forename: Günther
authors.initials: G
authors.lastname: Gastl
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000068256:Darbepoetin alfa; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications* / Q000188:drug therapy*; D011655:Pulmonary Embolism / Q000139:chemically induced; D013792:Thalidomide / Q000009:adverse effects* / Q000627:therapeutic use; D013923:Thromboembolism / Q000139:chemically induced* / Q000517:prevention & control; D020246:Venous Thrombosis / Q000139:chemically induced
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D007166:Immunosuppressive Agents; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D013792:Thalidomide