5-Azacitidine efficacy and safety in patients aged >65 years with myelodysplastic syndromes outside clinical trials

• DOI: 10.3109/10428194.2012.660632
• Publication Date: 2012-01-27T08:30:57Z
• Authors: Massimo Breccia; Giuseppina Loglisci; Adriano Salaroli; Alessandra Serrao; Luigi Petrucci; Marco Mancini; Giuliana Alimena
• Keywords: Aged, 80 and over; Male; Anemia, Refractory, with Excess of Blasts; Remission Induction; 3. Good health; Cohort Studies; Cytogenetics; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Myelodysplastic Syndromes; Myelodysplastic syndromes; azacitidine; elderly; outcome; safety; Azacitidine; Disease Progression; Humans; Female; Aged

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.