Low-dose azacitidine after allogeneic stem cell transplantation for acute leukemia.
BACKGROUND
: The authors hypothesized that low doses of the hypomethylating agent 5-azacitidine may maximize the graft-versus-leukemia effect and may be tolerated well after allogeneic transplantation (HSCT).


METHODS
: The drug was given to 17 patients with acute leukemia as salvage for disease recurrence after HSCT (n = 9 patients) or as maintenance therapy (n = 8 patients). 5-Azacitidine was given subcutaneously daily for 5 days and was repeated every 4 weeks at doses of 16 mg/m(2) (n = 4 patients), 24 mg/m(2) (n = 9 patients), and 40 mg/m(2) (n = 4 patients). A median of 8 cycles was delivered. The median follow-up was 16 months and 11 months after HSCT and 5-azacitidine treatment, respectively.


RESULTS
: Five of 9 patients with recurrent disease responded. Four of 13 responding patients developed disease recurrence while they were receiving 5-azacitidine after a median of 10 months. The actuarial 1-year event-free and overall survival rates were 55% and 90%, respectively. There were no extramedullary toxicities, and no graft-versus-host disease exacerbation was observed.


CONCLUSIONS
: Low-dose 5-azacitidine may induce durable remissions for patients who develop disease recurrence after HSCT. Further follow-up and a larger group of patients will be necessary to confirm these observations. Cancer 2009. (c) 2009 American Cancer Society.
Jabbour
Elias
E
Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Giralt
Sergio
S
Kantarjian
Hagop
H
Garcia-Manero
Guillermo
G
Jagasia
Madan
M
Kebriaei
Partow
P
de Padua
Leandro
L
Shpall
Elizabeth J
EJ
Champlin
Richard
R
de Lima
Marcos
M
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001374:Azacitidine / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007938:Leukemia / Q000628:therapy*; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D014184:Transplantation, Homologous
D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine