title: 5-azacitidine efficacy and safety in patients aged >65 years with myelodysplastic syndromes outside clinical trials.
abstract: The efficacy and safety of azacitidine in elderly patients (aged >65 years) with myelodysplastic syndromes (MDS) treated outside clinical trials are reported. Thirty-eight patients with MDS received azacitidine (75 mg/m(2), schedule 5+2 +2): seven patients were classified as having refractory cytopenia with multilineage dysplasia (RCMD), nine patients with refractory anemia with excess of blasts (RAEB) type 1, 18 patients with RAEB type 2 and four patients with chronic myelomonocytic leukemia type 2 (CMML-2). According to International Working Group (IWG) 2006 criteria, after the first four cycles we detected complete remission in seven patients (CR, 18%), improvement of bone marrow dysplasia and reduction of blast percentage in seven patients (partial response, 18%), stable disease in 20 patients (53%) and progression to acute leukemia in four patients (10%). Median overall survival for all patients treated was 16.4 months. Only mild non-hematologic toxicity was detected (grade 1-2 nausea and pruritus), whereas 55% of patients experienced hematologic side effects (25% grade 3-4 thrombocytopenia and 30% grade 3-4 neutropenia). Our results suggest that advanced age should not preclude effective treatment with azacitidine in non-selected elderly patients wih MDS.
authors.affiliation: Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy. breccia@bce.uniroma1.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Loglisci
authors.forename: Adriano
authors.initials: A
authors.lastname: Salaroli
authors.forename: Alessandra
authors.initials: A
authors.lastname: Serrao
authors.forename: Luigi
authors.initials: L
authors.lastname: Petrucci
authors.forename: Marco
authors.initials: M
authors.lastname: Mancini
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000754:Anemia, Refractory, with Excess of Blasts / Q000188:drug therapy*; D001374:Azacitidine / Q000627:therapeutic use*; D015331:Cohort Studies; D003582:Cytogenetics; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D001374:Azacitidine