Effectiveness of azacitidine in unselected high-risk myelodysplastic syndromes: results from the Spanish registry.
The benefit of azacitidine treatment in survival of high-risk myelodysplastic syndromes (MDS) patients compared with conventional care treatment (CCT) has not been established outside clinical trials. To assess its effectiveness, we compared overall survival (OS) between azacitidine and conventional treatment (CCT) in high-risk MDS patients, excluding those undergoing stem cell transplantation, submitted to the Spanish MDS registry from 2000 to 2013. Several Cox regression and competing risk models, considering azacitidine as a time-dependent covariate, were used to assess survival and acute myeloblastic leukemia (AML) progression. Among 821 patients included, 251 received azacitidine. Median survival was 13.4 (11.8-16) months for azacitidine-treated patients and 12.2 (11-14.1) for patients under CCT (P=0.41). In a multivariate model, age, International prognostic scoring system and lactate dehydrogenase were predictors of OS whereas azacitidine was not (adjusted odds ratio 1.08, 95% confidence interval 0.86-1.35, P=0.49). However, in patients with chromosome 7 abnormalities, a trend toward a better survival was observed in azacitidine-treated patients (median survival 13.3 (11-18) months) compared with CCT (median survival 8.6 (5-10.4) months, P=0.08). In conclusion, our data show that, in spite of a widespread use of azacitidine, there is a lack of improvement in survival over the years. Identification of predicting factors of response and survival is mandatory.
Servicio de Hematología, Hospital Universitario Central de Asturias, Departamento de Medicina, Universidad de Oviedo, Oviedo, Spain.
T
T
Bernal
Servicio de Hematología, Hospital Universitario Central de Asturias, Departamento de Medicina, Universidad de Oviedo, Oviedo, Spain.|Universidad Autónoma de Chile, Santiago de Chile, Chile.
P
P
Martínez-Camblor
IMIBIC, Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain.
J
J
Sánchez-García
Hospital Universitario La Paz, Madrid, Spain.
R
R
de Paz
Servicio de Hematología, Hospital Universitario Central de Asturias, Departamento de Medicina, Universidad de Oviedo, Oviedo, Spain.
E
E
Luño
Hospital Clinic, Barcelona, Spain.
B
B
Nomdedeu
Hospital de Txagorritxu, Victoria-Gasteiz, Spain.
M T
MT
Ardanaz
Hospital del Mar, Barcelona, Spain.
C
C
Pedro
Hospital Universitario Morales Messeguer, Murcia, Spain.
M L
ML
Amigo
Instituto catalán de Oncología, Instituto de Investigación Josep Carreras, Instituto Catalán de Oncología, Hospital Germans Trias i Pujol, Badalona, Spain.
B
B
Xicoy
Hospital Universitario de Salamanca, Salamanca, Spain.
C
C
del Cañizo
Hospital Clínico Universitario, Instituto de Investigación INCLIVA, Valencia, Spain.
M
M
Tormo
Hospital Son Llatzer, Palma de Mallorca, Spain.
J
J
Bargay
Hospital Vall D'Hebrón, Barcelona, Spain.
D
D
Valcárcel
Hospital Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain.
S
S
Brunet
Grupo Español de Síndromes Mielodisplásicos, Valencia, Spain.
L
L
Benlloch
Hospital Universitario y Politécnico La Fe, Valencia, Spain.
G
G
Sanz
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001374:Azacitidine / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D015470:Leukemia, Myeloid, Acute / Q000453:epidemiology / Q000209:etiology; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D012042:Registries; D013030:Spain / Q000453:epidemiology; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine