title: Hydroxyurea-related toxicity in 3,411 patients with Ph'-negative MPN.
abstract: Hydroxyurea (Hydroxycarbamide; HU) is commonly used for the long-term treatment of patients with Philadelphia-chromosome negative chronic myeloproliferative neoplasms (MPNs). It is considered a first-choice agent for the treatment of these disorders as underlined by the European Leukemia Net Consensus Conference [1], although it is formally approved for this indication in some countries only. The drug is reportedly well tolerated in the large majority of subjects, although systemic and/or localized toxicities have been reported. Consensus criteria for definition of "intolerance" to HU have been described;patients who develop intolerance are candidate for second-line therapy and, more recently, for investigational drugs. However, no epidemiologic information about the occurrence of the most clinically significant HU-associated adverse events is yet available. In this study, the authors report on a multicenter series of 3,411 patients who were treated with HU among which 184, accounting for 5% of total, developed significant drug-related toxicities. These data provide an estimate of the frequency and a detailed characterization of clinically significant HU-related toxicities; these information have relevance for the management of MPN patients who require second-line therapy after developing HU-related intolerance.
authors.affiliation: Hematology Unit, AOU Careggi Largo Brambilla 3, Firenze, IT.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Antonioli
authors.forename: Paola
authors.initials: P
authors.lastname: Guglielmelli
authors.forename: Lisa
authors.initials: L
authors.lastname: Pieri
authors.forename: MariaChiara
authors.initials: M
authors.lastname: Finazzi
authors.forename: Elisa
authors.initials: E
authors.lastname: Rumi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Martinelli
authors.forename: Nicola
authors.initials: N
authors.lastname: Vianelli
authors.forename: Maria
authors.initials: M
authors.lastname: Luigia Randi
authors.forename: Irene
authors.initials: I
authors.lastname: Bertozzi
authors.forename: Valerio
authors.initials: V
authors.lastname: De Stefano
authors.forename: Tommaso
authors.initials: T
authors.lastname: Za
authors.forename: Elena
authors.initials: E
authors.lastname: Rossi
authors.forename: Marco
authors.initials: M
authors.lastname: Ruggeri
authors.forename: Elena
authors.initials: E
authors.lastname: Elli
authors.forename: Rossella
authors.initials: R
authors.lastname: Cacciola
authors.forename: Emma
authors.initials: E
authors.lastname: Cacciola
authors.forename: Enrico
authors.initials: E
authors.lastname: Pogliani
authors.forename: Francesco
authors.initials: F
authors.lastname: Rodeghiero
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Francesco
authors.initials: F
authors.lastname: Passamonti
authors.forename: Guido
authors.initials: G
authors.lastname: Finazzi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
authors.forename: Mario
authors.initials: M
authors.lastname: Cazzola
authors.forename: Tiziano
authors.initials: T
authors.lastname: Barbui
authors.forename: Alessandro M
authors.initials: AM
authors.lastname: Vannucchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000963:Antimetabolites / Q000009:adverse effects* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000139:chemically induced / Q000453:epidemiology; D003875:Drug Eruptions / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D005334:Fever / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D006918:Hydroxyurea / Q000009:adverse effects* / Q000627:therapeutic use; D055623:Keratosis, Actinic / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009196:Myeloproliferative Disorders / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D011014:Pneumonia / Q000453:epidemiology / Q000209:etiology; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D012883:Skin Ulcer / Q000139:chemically induced / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000963:Antimetabolites; D006918:Hydroxyurea