Article (Scientific journals)
Safety and efficacy of azacitidine in Belgian patients with high-risk myelodysplastic syndromes, acute myeloid leukaemia, or chronic myelomonocytic leukaemia: results of a real-life, non-interventional post-marketing survey
Beguin, Yves; Selleslag, Dominik; Meers, Stef et al.
2015In Acta Clinica Belgica, 70, p. 34-43
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Keywords :
Azacitidine; Myelodysplastic syndromes; Acute myeloid leukaemia; Chronic myelomonocytic leukaemia
Abstract :
[en] Objectives: We evaluated azacitidine (VidazaH) safety and efficacy in patients with myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), and chronic myelomonocytic leukaemia (CMML), in a real-life setting. Treatment response, dose, and schedule were assessed. Methods: This non-interventional, post-marketing survey included 49/50 patients receiving azacitidine at 14 Belgian haematology centres from 2010–2012. Treatment-emergent adverse events (TEAEs), including treatment-related TEAEs, and serious TEAEs (TESAEs) were recorded throughout the study. Treatment response [complete response (CR), partial response (PR), haematological improvement (HI), stable disease (SD), treatment failure (TF)) and transfusion-independence (TI) were evaluated at completion of a 1-year observation period (1YOP) or at treatment discontinuation, and overall survival (OS), at study conclusion. Results: The median age of patients was 74.7 (range: 43.9–87.8) years; 69.4% had MDS, 26.5% had primary or secondary AML, and 4.1% had CMML. Treatment-related TEAEs, grade 3–4 TEAEs, and TESAEs were reported in 67.3%, 28.6%, and 18.4% of patients, respectively. During 1YOP, patients received a median of 7 (1–12) treatment cycles. Treatment response was assessed for 38/49 patients. Among MDS and CMML patients (n529), 41.4% had CR, PR, or HI, 41.4% had SD, and 17.2% had TF. Among AML patients (n59), 44.4% had CR or PR, 33.3% had SD, and 22.2% had TF. TI was observed in 14/32 (43.8%) patients who were transfusion-dependent at baseline. Median (95% confidence interval) OS was 490 (326–555) days; 1-year OS estimate was 0.571 (0.422–0.696). Conclusions: Our data support previous findings that azacitidine has a clinically acceptable safety profile and shows efficacy.
Disciplines :
Hematology
Author, co-author :
Beguin, Yves  ;  Université de Liège - ULiège > GIGA-R : Hématologie
Selleslag, Dominik
Meers, Stef
Graux, Carlos
Bries, Greet
Deeren, Dries
Vrelust, Inge
Ravoet, Christophe
Theunissen, Koen
Voelter, Verena
Potier, Hélène
Trullemans, Fabienne
Noens, Lucien
Mineur, Philippe
More authors (4 more) Less
Language :
English
Title :
Safety and efficacy of azacitidine in Belgian patients with high-risk myelodysplastic syndromes, acute myeloid leukaemia, or chronic myelomonocytic leukaemia: results of a real-life, non-interventional post-marketing survey
Publication date :
2015
Journal title :
Acta Clinica Belgica
ISSN :
0001-5512
Publisher :
Acta Clinica Belgica, Bruxelles, Belgium
Volume :
70
Pages :
34-43
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 27 January 2015

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