Azacitidine to treat measurable residual disease in patients with MDS/AML: final long-term results of the RELAZA2 trial

Journal Name
Blood
Primary Author
Platzbecker A
Author(s)
Georgi J , Middeke J , Sockel K , Wehner R , Herbst R , Wolf D , D Baldus C , Oelschlaegel U , Mütherig A , Fransecky L , Noppeney R , Bug G
Original Publication Date

Measurable residual disease (MRD) can predict relapse in patients with advanced myelodysplastic neoplasms (MDS) or acute myeloid leukemia: (uh-KYOOT my-uh-LOYD loo-KEE-mee-uh) A cancer of the blood cells. It happens when very young white blood cells (blasts) in the bone marrow fail to mature. The blast cells stay in the bone marrow and become to numerous. This slows production of red blood cells and platelets. Some cases of MDS become… (AML). We report the long-term efficacy and safety of MRD-guided preemptive azacitidine: It works by reducing the amount of methylation in the body. Methylation is a process that acts like a switch to turn off or “silence” genes in certain cells. When these genes (called tumor suppressor genes) are turned off, MDS cells and cancer cells can grow freely. Azacitidine is approved by the U… treatment to prevent relapse in the phase 2 RELAZA2 trial. Patients with MDS or AML after either intensive chemotherapy: (kee-moe-THER-uh-pee) The use of medicines that kill cells (cytotoxic agents). People with high-risk or intermediate-2 risk myelodysplastic syndrome (MDS) may be given chemotherapy to kill bone marrow cells that have an abnormal size, shape, or look. Chemotherapy hurts healthy cells along with… only or consecutive allogeneic stem cell transplantation were prospectively screened for imminent relapse by molecular MRD assessment. Patients who became MRD positive (MRDpos) during screening received azacitidine for up to 2 years to prevent relapse. The primary endpoint was the proportion of patients alive and relapse-free six months after azacitidine start. Of 357 patients screened, 119 (33.3%) became MRDpos, of whom 95 (79.8%) were eligible for azacitidine treatment. The primary endpoint was met; 60 (63%) patients were relapse-free (95% confidence interval 54-71%, P<0.0001) six months after azacitidine initiation with no new safety signals. Of 60 patients achieving MRD response during the first six cycles of azacitidine, 31 (52%) maintained response without hematological relapse for ≥2 years following azacitidine initiation. The median treatment-free duration following azacitidine discontinuation was 20.8 months; the longest ongoing response was 104 months. After a median follow-up of 6.6 years, 15 initial responders (25%) remained alive and in remission. Among screened patients who remained continuously MRDneg, 60-month overall survival and relapse-free survival were 88% and 79%, respectively. Continuously MRDneg patients display a very favorable prognosis. A majority of MRDpos patients can be effectively treated with azacitidine with potential long-term remission even after termination of azacitidine. Clinicaltrials.gov: NCT01462578.

Website Feedback

Please use this feedback form to report website issues only. For other issues concerning patients and families, please email help@aamds.org or use the Patient and Family Helpline here.