10-Day Decitabine Regimen May Be Less Toxic Than Chemotherapy Among Older Patients With AML

Compared with 3 + 7 chemotherapy, a 10-day decitabine regimen may have a superior safety profile among older patients being treated for acute myeloid leukemia (AML), according to research published in The Lancet Haematology. The decitabine regimen does not, however appear to improve overall survival rates.

Both patient and disease factors determine whether patients are eligible 3 + 7 chemotherapy, which is the anthracycline- or cytarabine-based standard remission induction strategy. Older patients are frequently not eligible for this regimen, suggesting new options are needed.

Previous research has also suggested that a 10-day schedule of decitabine may be effective at inducing disease remission without a high degree of toxicity. For this randomized phase 3 study (ClinicalTrials.gov Identifier: NCT02172872), researchers compared the safety and efficacy of a 10-day decitabine regimen compared with 3 + 7 chemotherapy among older patients with AML, with the intention of proceeding on protocol to hematopoietic stem cell transplantation (HSCT).

Overall, between 2014 and 2019, 606 patients were randomly assigned to the decitabine (303 patients) or 3 + 7 chemotherapy (303 patients) groups. In the decitabine vs 3 + 7 arms, the median age at baseline was 67 vs 68 years, respectively, 54% vs 60% of patients were male sex, 71% vs 72% of patients had de novo AML, and 25% vs 17% of patients had favorable risk disease per European Leukemia Net criteria.

The median follow-up was 4 years. Analysis showed, at this point, that the 4-year overall survival rate was 26% in the decitabine group vs 30% in the control group (hazard ratio for death, 1.04; P =.68). Furthermore, the number of patients who proceeded to on-protocol HSCT was similar (40% with decitabine vs 39% with 3 + 7 chemotherapy).

Grade 3 to 5 adverse events occurred in 84% of patients in the decitabine group vs 94% of patients in the control group; these included infection (41% vs 53%, respectively), oral mucositis (2% vs 10%), and diarrhea (1% vs 8%). A total of 35 patients (12%) in the decitabine group died because of a treatment-related adverse event compared with 14% of patients in the 3 + 7 chemotherapy group.

“Overall, 10-day decitabine could be considered a better-tolerated and sufficiently efficacious alternative to 3 + 7 induction in fit older patients with acute myeloid leukaemia without favourable genetics,” the authors wrote in their report.

Disclosures: This research was supported by Janssen Pharmaceuticals. Please see the original reference for a full list of disclosures.

Reference

Lübbert M, Wijermans PW, Kicinski M, et al. 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial. Lancet Haematol. 2023;10(11):e879-e889. doi:10.1016/S2352-3026(23)00273-9

This article originally appeared on Hematology Advisor