title: Results of treatment with azacitidine in patients aged ≥ 75 years included in the Spanish Registry of Myelodysplastic Syndromes.
abstract: The tolerability of azacitidine (AZA) allows its administration in elderly patients. The objective of this study was to analyze the clinical and biological characteristics, transfusion independence (TI), overall survival (OS) and toxicity in a series of 107 patients ≥ 75 years of age from the Spanish Registry of Myelodysplastic Syndromes (MDS) treated with AZA. The median age (range) was 78 (75-90) years. According to the World Health Organization (WHO) classification, 86/102 (84%) had MDS, 10/102 (10%) had mixed myeloproferative/myelodysplastic disorder and 6/102 (6%) had acute myeloblastic leukemia. Regarding MDS by the International Prognostic Scoring System on initiation of AZA, 38/84 (45%) were low-intermediate-1 risk and 46/84 (55%) were intermediate-2-high risk. Ninety-five patients (89%) were red blood cell or platelet transfusion dependent. The AZA schedule was 5-0-0 in 39/106 (37%) patients, 5-2-2 in 36/106 (34%) patients and 7 consecutive days in 31/106 (29%) patients. The median number of cycles administered was 8 (range, 1-30). Thirty-eight out of 94 (40%) patients achieved TI. Median OS (95% confidence interval [CI]) was significantly better in patients achieving TI (n = 38) compared to patients who did not (n = 56) (22 [20.1-23.9] months vs. 11.1 [4.8-17.5] months, p = 0.001). No significant differences were observed in TI rate and OS among the three different schedules. With a median follow-up of 14 (min-max, 1-50) months, the median OS (95% CI) of the 107 patients was 18 (12-23) months and the probability of OS (95% CI) at 2 years was 34% (22-46%). Cycles were delayed in 31/106 (29%) patients and 47/101 patients (47%) were hospitalized for infection. These results show that treatment with AZA was feasible and effective in this elderly population, with 40% achieving TI, having a better OS than patients not achieving it. The schedule of AZA administration did not affect efficacy and toxicity.
authors: Hematology Department of Institut Català d'Oncologia, Josep Carreras Research Institute - Hospital Germans Trias i Pujol , Badalona , Spain.
authors: Blanca
authors: B
authors: Xicoy
authors: María-José
authors: MJ
authors: Jiménez
authors: Olga
authors: O
authors: García
authors: Joan
authors: J
authors: Bargay
authors: Violeta
authors: V
authors: Martínez-Robles
authors: Salut
authors: S
authors: Brunet
authors: María-Jesús
authors: MJ
authors: Arilla
authors: Jaime
authors: J
authors: Pérez de Oteyza
authors: Rafael
authors: R
authors: Andreu
authors: Francisco-Javier
authors: FJ
authors: Casaño
authors: Carlos-Javier
authors: CJ
authors: Cervero
authors: Alicia
authors: A
authors: Bailén
authors: María
authors: M
authors: Díez
authors: Bernardo
authors: B
authors: González
authors: Ana-Isabel
authors: AI
authors: Vicente
authors: Carme
authors: C
authors: Pedro
authors: Teresa
authors: T
authors: Bernal
authors: Elisa
authors: E
authors: Luño
authors: María-Teresa
authors: MT
authors: Cedena
authors: Luis
authors: L
authors: Palomera
authors: Adriana
authors: A
authors: Simiele
authors: José-Manuel
authors: JM
authors: Calvo
authors: Víctor
authors: V
authors: Marco
authors: Eduardo
authors: E
authors: Gómez
authors: Marta
authors: M
authors: Gómez
authors: David
authors: D
authors: Gallardo
authors: Juan
authors: J
authors: Muñoz
authors: Raquel
authors: R
authors: de Paz
authors: Javier
authors: J
authors: Grau
authors: Josep-Maria
authors: JM
authors: Ribera
authors: Luis-Enrique
authors: LE
authors: Benlloch
authors: Guillermo
authors: G
authors: Sanz
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009190:Myelodysplastic Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D012042:Registries; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine
keywords: Myelodysplastic syndromes; azacitidine; elderly; response; safety