Posted: Wednesday, October 28, 2020
According to research published in Blood Advances, ibrutinib's addition to decitabine therapy did not appear to improve response or survival in patients with acute myeloid leukemia (AML) and myelodysplasia. Gert J. Ossenkoppele, MD, PhD, of VU University Medical Center in Amsterdam, and colleagues sought to determine the combination treatment’s effect on patients who were newly diagnosed, at higher risk, and considered unsuitable for intensive chemotherapy.
The HOVON135/SAKK-30/15 phase II trial included 144 patients who were randomly assigned to receive 10-day decitabine either as monotherapy (n = 72; arm A) or combined with 560 mg of ibrutinib administered sequentially after the final dose of decitabine (n = 72; arm B). A total of 50% of patients in arm A achieved complete remission or complete remission with incomplete hematologic recovery versus 41% in arm B. Overall survival was also comparable between the groups, with median overall survivals of 11.5 months in arm A versus 11 months in arm B and a 2-year overall survival of 21% in arm A versus 27% in arm B. The occurrence of adverse events was similar across study arms, suggesting the addition of ibrutinib was well tolerated.
Patients who were found to have STAG2, IDH2, and ASXL1 mutations at the time of diagnosis had substantially lower rates of complete remission or complete remission with incomplete hematologic recovery. Patients with TP53 mutations were observed to have significantly higher rates of complete remission or complete remission with incomplete hematologic recovery. Of the 57 patients with available bone marrow samples, 28 (49%) were found by multicolor flow cytometry to have no measurable residual disease, which seemed to have no apparent impact on survival in this limited patient population.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.