Commenting on this trial, Marlise Luskin, MD, of Dana-Farber Cancer Institute, Boston, explained that the treatment of AML in older adults remains a particular challenge for leukemia clinicians.
“Although many older patients eligible for intensive induction chemotherapy achieve complete remission, the vast majority will relapse within months, which severely limits survival,” Dr. Luskin said. “Older patients with AML who remain fit after achievement of complete response are offered allogeneic stem cell transplant [HSCT] with a goal of cure. However, the best approach to extend remission in patients unable to pursue HSCT has not been defined.”
“The phase III QUAZAR AML-001 trial recently reported that oral azacitidine compared with placebo improves overall survival [by a median of 9.9 months from 14.8 to 24.7 months] in patients 55 years and older in complete remission after intensive chemotherapy who cannot proceed to HSCT. It is very important to note this drug is not bioequivalent to injectable azacitidine and is not approved for use in other clinical settings,” Dr. Luskin emphasized.
Marlise Luskin, MD
“In older patients, the impact of therapeutic approaches on quality of life is important, so the study investigators are to be commended for including robust health-related quality-of-life assessments as part of this trial. It is notable that the rate of completion of quality-of-life assessments was extremely high [greater than 90%], providing a robust data set and demonstration of feasibility, which will hopefully encourage other investigators to include such assessments as part of their trials. The key finding was that patients in both arms had a high quality of life. There was no evidence of deterioration of quality of life in the interventional arm, suggesting that older patients will have the chance to experience the life-extending potential of [oral azacitidine] without compromising the quality of that life,” she continued.
“In summary, this abstract demonstrates that [oral azacitidine] is a tolerable therapeutic option for older patients in first complete remission to extend their remission duration. Of course, the survival gains achieved by the QUAZAR AML-001 study were modest, and we hope to see further advances in the coming years. Subsequent studies must also include quality-of-life assessments to ensure that impacts on both survival and quality of life are understood,” Dr. Luskin stated.
DISCLOSURE: Dr. Luskin reported no conflicts of interest.
Health-related quality of life was sustained in patients taking oral azacitidine (also known as CC-486) compared with placebo in patients with acute myeloid leukemia (AML), according to results of the phase III QUAZAR AML-001 trial reported at the 2020 American Society of Hematology (ASH) Annual...