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Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C.

Abstract
In the phase III AZA-001 trial, low-dose cytarabine (LDara-C), the most widely used low-dose chemotherapy in patients with higher-risk myelodysplastic syndrome (MDS) who are ineligible for intensive treatment, was found to be associated with poorer survival compared with azacitidine. This analysis further compared the efficacy and the toxicity of these two drug regimens. Before randomization, investigators preselected patients to receive a conventional care regimen, one of which was LDara-C. Of 94 patients preselected to LDara-C, 45 were randomized to azacitidine and 49 to LDara-C. Azacitidine patients had significantly more and longer haematological responses and increased red blood cell transfusion independence. Azacitidine prolonged overall survival versus LDara-C in patients with poor cytogenetic risk, presence of -7/del(7q), and French-American-British subtypes refractory anaemia with excess blasts (RAEB) and RAEB in transformation. When analyzed per patient year of drug exposure, azacitidine treatment was associated with fewer grade 3-4 cytopenias and shorter hospitalisation time than LDara-C in these higher-risk MDS patients.
AuthorsPierre Fenaux, Norbert Gattermann, John F Seymour, Eva Hellström-Lindberg, Ghulam J Mufti, Ulrich Duehrsen, Steven D Gore, Fernando Ramos, Odile Beyne-Rauzy, Alan List, David McKenzie, Jay Backstrom, Charles L Beach
JournalBritish journal of haematology (Br J Haematol) Vol. 149 Issue 2 Pg. 244-9 (Apr 2010) ISSN: 1365-2141 [Electronic] England
PMID20136825 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antimetabolites, Antineoplastic
  • Cytarabine
  • Azacitidine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
  • Azacitidine (adverse effects, therapeutic use)
  • Cytarabine (adverse effects, therapeutic use)
  • Drug Administration Schedule
  • Erythrocyte Transfusion
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myelodysplastic Syndromes (drug therapy)
  • Survival Analysis
  • Treatment Outcome

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