Efficacy of 10-day decitabine in acute myeloid leukemia

Abstract

The azanucleotide decitabine is used in the treatment of acute myeloid leukemia (AML). Studies have shown conflicting results with 10-day regimens used in previously untreated AML patients. Additionally, there is little data on 10-day decitabine regimens in the relapsed setting. This study investigated outcomes of 108 adult patients with AML in the upfront and relapsed setting treated with a 10-day decitabine regimen. In the upfront group, the overall response rate (ORR, CR + CRi) was 36.1% and the median overall survival (OS) was 6.6 months, while the relapsed/refractory group had an ORR of 25% with an OS of 4.8 months. When analyzed with respect to cytogenetics, the upfront group featured an ORR of 28.1% with an OS of 9.4 months in the intermediate cytogenetic cohort compared to a 40.5% ORR and an OS of 5.4 months in the unfavorable cytogenetic cohort. An analysis of the relapsed/refractory group demonstrated an ORR of 26.3% with an OS of 7.9 months for intermediate cytogenetics versus 25.0% with an OS of 1.8 months in the unfavorable cohort. While these response rates are similar to previously published data, the median OS appears shorter.

Keywords: Acute myeloid leukemia; Decitabine; Real world outcomes; Treatment.

FIGURES A-D:

Figure A demonstrates a Kaplan-Meier survival curve featuring the 33 patients with primary AML after upfront decitabine induction versus the 24 patients with therapy-related AML (median OS: 266.5 days vs 133 days, respectively). While there appeared to be improved survival in primary AML, especially in the first year, a log-rank test did not show statistical significance (p-value: 0.1879). Figure B is a Kaplan-Meier survival curve revealing no significant difference between 33 patients with primary AML in the upfront setting and 25 patients with MDS treated with upfront decitabine (p-value: 0.3282, median OS: 266.5 days vs 197 days, respectively). Figure C shows a Kaplan-Meier curve revealing a survival difference between 32 patients with intermediate cytogenetics and 37 patients with unfavorable cytogenetics in the upfront setting, which was statistically significant (p-value: 0.0333, median OS: 282 days vs 161 days, respectively). Figure D shows a Kaplan-Meier curve showing another statistically significant difference between 19 patients with intermediate cytogenetics and 16 patients with unfavorable cytogenetics, this time in the relapsed and refractory setting (p-value: 0.0153, median OS: 238 days vs 53 days, respectively).