A retrospective study of azacitidine treatment in patients with intermediate-2 or high risk myelodysplastic syndromes in a real-world clinical setting in Greece.
For patients with intermediate-2 or high risk [according to the International Prognostic Scoring System (IPSS)] myelodysplastic syndromes (MDS), azacitidine treatment offers hematologic improvement (HI) but also has the potential to modify the natural disease course. 'RETRO-AZA-MDS-001', a retrospective chart review study was conducted from February to November 2012 across 17 hematology hospital sites of Greece, aiming to evaluate the clinical efficacy and safety profile of azacitidine in IPSS intermediate-2/high risk adult MDS patients in routine care. A total of 88 patients (median age 74.7 years), with a 6.6 month median (range 1.0-49.5) azacitidine treatment duration were enrolled. The overall response rate [complete response (CR), marrow CR and partial response] was 37.7% (23/61), while stable disease with HI was achieved by 21.3% (13/61). The HI rate was 33.0 % (29/88) and the AML transformation rate 6.8% (6/88). Of the transfusion-dependent patients, 7.3% (3/41) became transfusion-independent during azacitidine treatment. The incidence of non-serious and serious adverse events related to azacitidine was 50.0 and 42.0%, respectively. Patients not receiving prior ESA therapy were expected to be 7.6 times more likely to achieve a clinical response (p = 0.012). The study corroborates the favorable risk-benefit profile of azacitidine for intermediate-2/high risk MDS patients in routine clinical practice.
University General Hospital 'Attikon', 1, Rimini Str, Chaidari, 12462, Athens, Greece. vas_pappa@yahoo.com.
Vasiliki
http://orcid.org/0000-0003-0421-9424
V
Pappa
General Hospital of Thessaloniki 'G. Papanikolaou', Eksoxi, 57010, Thessaloniki, Greece.
Achilles
A
Anagnostopoulos
University General Hospital of Larissa, Mezourlo, 41110, Larissa, Greece.
Eleni
E
Bouronikou
University Hospital of Ioannina, 45100, Ioannina, Greece.
Evangelos
E
Briasoulis
Department of Hematology, Medical School, Democritus University of Thrace, Xanthi, Greece.
Ioannis
I
Kotsianidis
General Hospital of Athens 'Evaggelismos', Ipsilantou 45, 10676, Athens, Greece.
Maria
M
Pagoni
General Hospital of Patras 'Agios Andreas', Tsertidou 1, 26335, Patras, Greece.
Panagiotis
P
Zikos
'251' General Airforce Hospital, Kanellopoulou 3, 11525, Athens, Greece.
Konstantinos
K
Tsionos
'Laiko' General Hospital of Athens, Agiou Thoma 17, 11527, Athens, Greece.
Nora
N
Viniou
'Laiko' General Hospital of Athens, Agiou Thoma 17, 11527, Athens, Greece.
John
J
Meletis
University General Hospital of Heraklion, Voutes, 71110, Heraklion, Greece.
Helen
H
Papadaki
General Hospital of Thessaloniki 'Papageorgiou', Circular Road Neas Efkarpias, 56429, Thessaloniki, Greece.
Anna
A
Kioumi
General Hospital of Athens 'G. Gennimatas', Mesogeion 154, 11527, Athens, Greece.
Athanasios
A
Galanopoulos
'Henry Dunant' Hospital, 107 Mesogeion Av, 11526, Athens, Greece.
Elisavet-Christine
EC
Vervessou
'401' Army General Hospital of Athens, Mesogeion and Kanellopoulou 1, 11525, Athens, Greece.
Elias
E
Poulakidas
Army Share Fund Hospital 'NIMTS', Monis Petraki 10, 11521, Athens, Greece.
Panagiotis
P
Karmas
GENESIS Pharma SA, 270 Kifisias Av, 15232, Athens, Greece.
Kiki
K
Karvounis
General University Hospital of Patras, Rio Patron, 26500, Patras, Greece.
Argiris
A
Symeonidis
D000368:Aged; D001374:Azacitidine / Q000009:adverse effects / Q000627:therapeutic use*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D005260:Female; D006115:Greece; D006801:Humans; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D012189:Retrospective Studies; D012306:Risk; D016896:Treatment Outcome
D001374:Azacitidine
AML transformation; Azacitidine; Hematologic improvement; Myelodysplastic syndromes; Response rate; Safety