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Jorge E. Cortes, MD, deputy chair of the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses the data from the QuANTUM-R trial presented at the 2018 ASH Annual Meeting in relapsed/refractory acute myeloid leukemia (AML).
Jorge E. Cortes, MD, deputy chair of the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses the data from the QuANTUM-R trial presented at the 2018 ASH Annual Meeting in relapsed/refractory acute myeloid leukemia (AML).
In the QuANTUM-R trial, patients with relapsed/refractory AML were randomized to receive quizartinib or physician’s choice salvage chemotherapy. This included low-dose cytarabine; mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte-colony stimulating factor with idarubicin (Idamycin; FLAG-IDA). The primary endpoint of the trial was overall survival.
The hazard ratio was 0.76, which resulted in a 24% reduction in the risk of death with quizartinib in the observation phase of this trial. This was coupled with an improvement in the response rate for patients treated with quizartinib. The composite complete remission rate was 48% in those who received quizartinib compared with 27% in those who were given salvage chemotherapy.
Importantly, the treatment was well tolerated, says Cortes. Although QTcF prolongation was a concern based on the initial phase I study, the doses that were used in this trial showed very low QTcF rates, which were not associated with serious arrhythmias or other issues, he adds.
Ultimately, this was a positive study that showed that quizartinib is a better-tolerated and more efficacious treatment than intensive, aggressive chemotherapy.