Efficacy and Safety of Decitabine in Chinese Elderly Patients with Acute Myeloid Leukemia (AML): Results Analysis of DACOGENAML2003

Corresponding Author: Jianxiang Wang.

Background: Older patients with AML generally have a poor prognosis. Intensive chemotherapy may improve survival for some elderly patients with AML, while others may be unfit or unwilling to accept this kind of treatment. Decitabine (10-day regimen) was reported benefit in elderly AML patients, while the efficacy and safety are unknown in Chinese elderly AML patients.

Aim: In this prospective study, we aimed to investigate the efficacy and safety of decitabine in elderly patients with AML defined according to WHO 2008.

Method: Between 2012-2014, ≥60 year-old patients with AML were included in our Hospital. Eligibility criteria included Clinical diagnosis of De novo or secondary AML. Before the enrollment, WBC < 40×10⁹/L, Plt > 20×10⁹/L. In 2 weeks before the enrollment, patients with acceptable organ function and predicted lifetime longer than 12 weeks. Acute promyelocytic leukemia or Chromosome and genetic abnormalities related with t (8; 21) 、inv (16) 、t (15; 17) was excluded. Demographic data, comorbidities, ECOG status, cytogenetic risk status, adverse events and treatment responses were recorded. Decitabine was delivered at a dosage of 20mg/m² ivdrip more than 1 hour from day 1 to day 10 every 28 days in the induction cycles. When the blasts ratio was less than 5%, the drug was reduced to 5 days. Assessment of response was performed after 4 cycles.

Results: Twenty patients (12 males) receiving decitabine were included in the study. Median age was 64 years (60-74 years).ECOG performance status was 0-2. Median WBC was 4.15×10⁹/L(1.04-38.79). According to cytogenetic and molecular abnormalities, the patients risk status were as following: favorable 4/20, intermediate 9/20, adverse 7/20. Patients received decitabine for a median of 4 cycles (1-7 cycles). The complete remission rate (CR) was 60% with median 2 cycles (range 1-4) to obtain CR. The median overall survival (OS) was 15.5 months (range 1-28) in all the patients, for the responders and non-responders, the median OS was 17 months (range 12-28) and 6 months (range 1-19) respectively (p=0.003). The median disease-free survival (DFS) was 12.5 months (range 3.3-26). The 60 day mortality rate was 5%. Grate 3-4 neutropenia, thromobocytopenia and anemia was documented 95%, 80% and 95% respectively during remission induction. Median platelet transfusion was 4u (1-8u). Febrile neutropenia was documented in 15 patients, including one episode of sepsis. Non-hematologic toxicities were mild and tolerated well, most common adverse effect being nausea.

Conclusion: Decitabine 10 days regimen induced a CR rate of 60% and tolerated well, the OS in responders is superior to that of the non-responders. Grate 3-4 hematologic toxicities are common, but serious adverse effect is rare. It is effective and safety for Chinese elderly AML patients who are unable or unwilling to accept intensive chemotherapy.

Conflict of interest statement: the authors declare no conflict of interest.