title: [Hydroxyurea--is it a harmless drug in Vaquez disease?]].
abstract: The frequent side effects of Hydroxy-Urea and the non-exceptional risk of leukemia and cancer in Polycythemia Vera treated for a long time by Hydroxy-Urea allow to conclude that Hydroxy-Urea is not an innocent drug. In a prospective trial of 150 patients with a median follow up of nine years, Hydroxy-Urea given alone induced side effects in 29% of patients necessitating to stop treatment in half of cases. The percentage of leukemia or myelodysplasia is 6.7% with an actuarial risk of leukemic transformation of 10% at 13 years. In an other prospective trial in 181 aged patients Hydroxy-Urea was given as maintenance therapy after 32P treatment. The median follow-up in that study is also of nine years. Side effects are observed in 13% of cases. A two fold increase of the leukemic risk was observed in the maintenance arm of the trial: 11 versus 19% at ten years, 14 vs 30% at 12 years, 16 vs 35% at 15 years because of the leukemogenic effect of Hydroxy-Urea in maintenance therapy we stopped including new patients in this arm of the trial.
authors.affiliation: Département de médecine nucléaire, hôpital Saint-Louis, I, avenue Claude Vellefaux 75475 Paris, France.
authors.forename: J D
authors.initials: JD
authors.lastname: Rain
mesh_terms: D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D003131:Combined Modality Therapy; D003556:Cystitis / Q000139:chemically induced; D007172:Erectile Dysfunction / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D006918:Hydroxyurea / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D007871:Leg Ulcer / Q000139:chemically induced; D007938:Leukemia / Q000139:chemically induced / Q000453:epidemiology; D008228:Lymphoma, Non-Hodgkin / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009436:Neural Tube Defects / Q000139:chemically induced; D010761:Phosphorus Radioisotopes / Q000627:therapeutic use; D010885:Pipobroman / Q000627:therapeutic use; D011087:Polycythemia Vera / Q000188:drug therapy* / Q000532:radiotherapy; D011446:Prospective Studies; D012306:Risk; D012449:Safety; D013281:Stomatitis, Aphthous / Q000139:chemically induced
chemical_list: D010761:Phosphorus Radioisotopes; D010885:Pipobroman; D006918:Hydroxyurea