title: Azacitidine for treatment of imminent relapse in MDS or AML patients after allogeneic HSCT: results of the RELAZA trial.
abstract: This study evaluated azacitidine as treatment of minimal residual disease (MRD) determined by a sensitive donor chimerism analysis of CD34(+) blood cells to pre-empt relapse in patients with CD34(+) myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplantation (HSCT). At a median of 169 days after HSCT, 20/59 prospectively screened patients experienced a decrease of CD34(+) donor chimerism to <80% and received four azacitidine cycles (75 mg/m(2)/day for 7 days) while in complete hematologic remission. A total of 16 patients (80%) responded with either increasing CD34(+) donor chimerism to ≥80% (n=10; 50%) or stabilization (n=6; 30%) in the absence of relapse. Stabilized patients and those with a later drop of CD34(+) donor chimerism to <80% after initial response were eligible for subsequent azacitidine cycles. A total of 11 patients (55%) received a median of 4 (range, 1-11) additional cycles. Eventually, hematologic relapse occurred in 13 patients (65%), but was delayed until a median of 231 days (range, 56-558) after initial decrease of CD34(+) donor chimerism to <80%. In conclusion, pre-emptive azacitidine treatment has an acceptable safety profile and can substantially prevent or delay hematologic relapse in patients with MDS or AML and MRD after allogeneic HSCT.
authors: Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Technical University of Dresden, Dresden, Germany. uwe.platzbecker@uniklinikum-dresden.de
authors: U
authors: U
authors: Platzbecker
authors: M
authors: M
authors: Wermke
authors: J
authors: J
authors: Radke
authors: U
authors: U
authors: Oelschlaegel
authors: F
authors: F
authors: Seltmann
authors: A
authors: A
authors: Kiani
authors: I-M
authors: IM
authors: Klut
authors: H
authors: H
authors: Knoth
authors: C
authors: C
authors: Röllig
authors: J
authors: J
authors: Schetelig
authors: B
authors: B
authors: Mohr
authors: X
authors: X
authors: Graehlert
authors: G
authors: G
authors: Ehninger
authors: M
authors: M
authors: Bornhäuser
authors: C
authors: C
authors: Thiede
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000627:therapeutic use*; D046528:Chimerism; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D018365:Neoplasm, Residual / Q000628:therapy; D012008:Recurrence; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine