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.
Standard dose and prolonged administration of azacitidine are associated with improved efficacy in a real-world group of patients with myelodysplastic syndrome or low blast count acute myeloid leukemia / Voso, Maria Teresa; Niscola, Pasquale; Piciocchi, Alfonso; Fianchi, Luana; Maurillo, Luca; Musto, Pellegrino; Pagano, Livio; Mansueto, Giovanna; Criscuolo, Marianna; ALOE SPIRITI, Maria Antonietta; Buccisano, Francesco; Venditti, Adriano; Tendas, Andrea; Piccioni, Anna Lina; Zini, Gina; Latagliata, Roberto; Filardi, Nunzio; Fragasso, Alberto; Fenu, Susanna; Breccia, Massimo. - In: EUROPEAN JOURNAL OF HAEMATOLOGY. - ISSN 0902-4441. - STAMPA. - 96:4(2016), pp. 344-351. [10.1111/ejh.12595]
Standard dose and prolonged administration of azacitidine are associated with improved efficacy in a real-world group of patients with myelodysplastic syndrome or low blast count acute myeloid leukemia
ALOE SPIRITI, Maria Antonietta;Breccia, Massimo
2016
Abstract
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.File | Dimensione | Formato | |
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