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

Objectives: We evaluated azacitidine (Vidaza (R)) 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 respo... Mehr ...

Verfasser: Beguin, Y
Selleslag, D
Meers, S
Graux, C
Bries, G
Deeren, D
Vrelust, I
Ravoet, C
Theunissen, K
Voelter, V
Potier, H
Trullemans, F
Noens, Lucien
Mineur, P
Dokumenttyp: journalarticle
Erscheinungsdatum: 2015
Schlagwörter: Medicine and Health Sciences / Acute myeloid leukaemia / Chronic myelomonocytic leukaemia / Myelodysplastic syndromes / Azacitidine / MARROW-TRANSPLANTATION EBMT / INTERNATIONAL WORKING GROUP / CONVENTIONAL CARE REGIMENS / STEM-CELL TRANSPLANTATION / WORLD-HEALTH-ORGANIZATION / RESPONSE CRITERIA / EUROPEAN-GROUP / MDS PATIENTS / DISEASE / BEHALF
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28878811
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://biblio.ugent.be/publication/5970881

Objectives: We evaluated azacitidine (Vidaza (R)) 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 (n=29), 41.4% had CR, PR, or HI, 41.4% had SD, and 17.2% had TF. Among AML patients (n=9), 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.