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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.
AuthorsMassimo Breccia, Giuseppina Loglisci, Adriano Salaroli, Alessandra Serrao, Luigi Petrucci, Marco Mancini, Giuliana Alimena
JournalLeukemia & lymphoma (Leuk Lymphoma) Vol. 53 Issue 8 Pg. 1558-60 (Aug 2012) ISSN: 1029-2403 [Electronic] United States
PMID22280532 (Publication Type: Journal Article)
Chemical References
  • Azacitidine
Topics
  • Aged
  • Aged, 80 and over
  • Anemia, Refractory, with Excess of Blasts (drug therapy)
  • Azacitidine (therapeutic use)
  • Cohort Studies
  • Cytogenetics
  • Disease Progression
  • Female
  • Humans
  • Male
  • Myelodysplastic Syndromes (drug therapy)
  • Remission Induction
  • Treatment Outcome

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