Journal
EUROPEAN JOURNAL OF HAEMATOLOGY
Volume 96, Issue 4, Pages 344-351Publisher
WILEY
DOI: 10.1111/ejh.12595
Keywords
azacitidine; MDS; AML
Categories
Funding
- Regione Lazio: 'Sindromi mielodisplastiche dell'adulto nell'area di Roma e del Lazio: Grant-Progetti di farmacovigilanza Area tematica 5'
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ObjectiveAzacitidine is the standard of care for higher-risk myelodysplastic syndromes (MDS). We evaluated factors affecting the outcome of azacitidine treatment in 196 real-world' patients, retrospectively collected by two Italian cooperative groups. MethodsThe study included 184 MDS and 12 low blast count acute myeloid leukemia (AML). Azacitidine was administered at the standard dose of 75mg/m(2)/d for 7d (SD) in 163 patients and 100mg/d for 5-7d in 33 patients. ResultsAfter a median of 4.5 azacitidine cycles (range 7-15 cycles), 182 patients were evaluable for response. Nineteen percent achieved complete remission (CR), 17% partial remission (PR), and 21% hematological improvement (HI). The disease was stable or progressive in 29% and 14% of patients, respectively. The probability of response was significantly higher in patients who received the 75mg/m(2)/7d compared with 100mg through 5-7d dose (CR/PR/HI: 63 vs. 29%, P=0.0005). Median overall survival was 17.1months. Low MDS-CI and achievement of CR/PR/HI were significant predictors of survival in the multivariable analysis. ConclusionsOur data show that maximal azacitidine efficacy is associated with the standard dose and with prolonged treatment, beyond 4-6 cycles, with the goal of also improving the quality' of response. Lower MDS-CI and IPSS-R scores, hematologic response and disease stability, are associated with longer survival. The risk of febrile events is highest during the first treatment cycles and is associated with active disease.
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