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A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia.

Authors :
Sweet, Kendra
Bhatnagar, Bhavana
Döhner, Hartmut
Donnellan, Will
Frankfurt, Olga
Heuser, Michael
Kota, Vamsi
Liu, Hongtao
Raffoux, Emmanuel
Roboz, Gail J.
Röllig, Christoph
Showel, Margaret M.
Strickland Jr., Stephen A.
Vives, Susana
Tang, Shijie
Unger, Thaddeus J.
Joshi, Anita
Shen, Yao
Alvarez, Mariano J.
Califano, Andrea
Source :
Leukemia & Lymphoma. Dec 2021, Vol. 62 Issue 13, p3192-3203. 12p.
Publication Year :
2021

Abstract

Selinexor, a selective inhibitor of nuclear export, has demonstrated promising activity in patients with acute myeloid leukemia (AML). This randomized, phase II study evaluated selinexor 60 mg twice weekly (n = 118) vs. physician's choice (PC) treatment (n = 57) in patients aged ≥60 years with relapsed/refractory (R/R) AML. The primary outcome was overall survival (OS). Median OS did not differ significantly for selinexor vs. PC (3.2 vs. 5.6 months; HR = 1.18 [95% CI: 0.79–1.75]; p = 0.422). Complete remission (CR) plus CR with incomplete hematologic recovery trending in favor of selinexor occurred in a minority of patients. Selinexor treated patients had an increased incidence of adverse events. The most common grade ≥3 adverse events were thrombocytopenia, febrile neutropenia, anemia, hyponatremia. Despite well-balanced baseline characteristics, there were numerically higher rates of TP53 mutations, prior myelodysplastic syndrome, and lower absolute neutrophil counts in the selinexor group; warranting further investigation of selinexor in more carefully stratified R/R AML patients. Registered trial: NCT02088541. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10428194
Volume :
62
Issue :
13
Database :
Academic Search Index
Journal :
Leukemia & Lymphoma
Publication Type :
Academic Journal
Accession number :
153935034
Full Text :
https://doi.org/10.1080/10428194.2021.1950706