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Itzykson, Raphael; Thépot, Sylvain; Quesnel, Bruno; Dreyfus, Francois; Beyne-Rauzy, Odile; Turlure, Pascal; Vey, Norbert; Recher, Christian; Dartigeas, Caroline; Legros, Laurence; Delaunay, Jacques; Salanoubat, Célia; Visanica, Sorin; Stamatoullas, Aspasia; Isnard, Francoise; Marfaing-Koka, Anne; de Botton, Stephane; Chelghoum, Youcef; Taksin, Anne-Laure; Plantier, Isabelle; Ame, Shanti; Boehrer, Simone; Gardin, Claude; Beach, C.L.; Adès, Lionel; Fenaux, Pierre
Blood, 01/2011, Volume: 117, Issue: 2Journal Article
Prognostic factors for response and survival in higher-risk myelodysplastic syndrome patients treated with azacitidine (AZA) remain largely unknown. Two hundred eighty-two consecutive high or intermediate-2 risk myelodysplastic syndrome patients received AZA in a compassionate, patient-named program. Diagnosis was RA/RARS/RCMD in 4%, RAEB-1 in 20%, RAEB-2 in 54%, and RAEB-t (AML with 21%-30% marrow blasts) in 22%. Cytogenetic risk was good in 31%, intermediate in 17%, and poor in 47%. Patients received AZA for a median of 6 cycles (1-52). Previous low-dose cytosine arabinoside treatment (P = .009), bone marrow blasts > 15% (P = .004), and abnormal karyotype (P = .03) independently predicted lower response rates. Complex karyotype predicted shorter responses (P = .0003). Performance status ≥ 2, intermediate- and poor-risk cytogenetics, presence of circulating blasts, and red blood cell transfusion dependency ≥ 4 units/8 weeks (all P < 10−4) independently predicted poorer overall survival (OS). A prognostic score based on those factors discriminated 3 risk groups with median OS not reached, 15.0 and 6.1 months, respectively (P < 10−4). This prognostic score was validated in an independent set of patients receiving AZA in the AZA-001 trial (P = .003). Achievement of hematological improvement in patients who did not obtain complete or partial remission was associated with improved OS (P < 10−4). In conclusion, routine tests can identify subgroups of patients with distinct prognosis with AZA treatment.
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