ATRA Plus Decitabine in Nonfit Elderly Patients With Acute Myeloid Leukemia
Posted: Friday, March 13, 2020
According to a multicenter, randomized phase II trial, decitabine plus all-trans retinoic acid (ATRA) improved survival results without added toxicity among nonfit elderly patients with acute myeloid leukemia (AML). Michael Lübbert, MD, of the University of Freiburg, Germany, and colleagues also suggested that the combination resulted in higher remission rates compared with patients who were treated with decitabine plus valproate, decitabine plus valproate and ATRA, or decitabine alone. The findings were published in the Journal of Clinical Oncology.
The researchers randomly assigned 200 patients with treatment-naive acute myeloid leukemia to receive decitabine in combination with valproate (n = 57), ATRA (n = 46), valproate plus ATRA (n = 50), or decitabine alone (n = 47). The median age of patients was 76, and they were ineligible for induction chemotherapy. The research team set the significance level at α = .10.
The remission rate for patients in the decitabine-plus-ATRA group was 21.9%, compared with 13.5% in the group that received decitabine alone (P = .06). Patients who received ATRA plus decitabine also achieved longer overall survival than those treated with decitabine alone; the median overall survival was 8.2 months with ATRA and 5.1 months without it (P = .006). The researchers did not observe any effect on remission or survival among patients who received valproate versus those who did not. Adverse events were generally hematologic, and the investigators did not observe significant differences in toxicity profiles between the four treatment arms.
“The results therefore warrant confirmation in a placebo-controlled randomized trial and a search for biomarkers to predict response to this combination treatment,” the research team concluded.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.