Maintenance Selinexor After Allo-HCT for High-Risk AML
Posted: Tuesday, June 16, 2020
For patients with high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), maintenance therapy with the selective inhibitor selinexor may be a safe and practical treatment option, according to findings presented in Bone Marrow Transplantation. Hongtao Liu, MD, PhD, of the University of Chicago Medicine, and colleagues also determined the maximum tolerated dose for patients was 60 mg/week.
“Maintenance therapy with selinexor merits further study in order to further assess efficacy in preventing or delaying relapse,” the authors concluded.
In this phase I trial, the authors enrolled 12 patients with AML and MDS who had undergone an allogeneic hematopoietic stem cell transplant (allo-HCT), with no evidence of relapse, active infection, or unresolved transplant-related toxicities. Two escalating doses of selinexor were used: a 60-mg oral daily dose and an 80-mg oral weekly dose . The patients remained on selinexor maintenance for a median of 224 days.
To date, six patients relapsed, five of whom died of progressive disease. For all study patients, the median progression-free survival was 775 days, with a median overall survival of 872 days. Four patients completed 12 cycles of maintenance therapy with selinexor, three of whom did not experience relapse; one patient relapsed 981 days after transplant (and subsequently died).
For all study patients, the 1-year progression-free survival rate was 66%, and the 2-year progression-free survival rate was 50%. The most common adverse events were nausea (91.7%), anorexia (66.7%), fatigue (66.7%), vomiting (25%), and diarrhea (18%).
Disclosure: For full disclosures of the study authors, visit nature.com.