The Association between Patient Characteristics and the Efficacy and Safety of Selinexor in Diffuse Large B-Cell Lymphoma in the SADAL Study.
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Authors
Follows, George
Kalakonda, Nagesh
Choquet, Sylvain
Hill, Brian
Thieblemont, Catherine
Cruz, Fatima De la
Kuruvilla, John
Hamad, Nada
Jaeger, Ulrich
Caimi, Paolo
Gurion, Ronit
Warzocha, Krzysztof
Bakhshi, Sameer
Schuster, Michael
Egyed, Miklos
Offner, Fritz
Vassilakopoulos, Theodoros P
Samal, Priyanka
Ku, Matthew
Xu, Jenny
Corona, Kelly
Chamoun, Kamal
Shah, Jatin
Canales, Miguel
Maerevoet, Marie
Publication Date
2022-02-04Journal Title
Cancers (Basel)
ISSN
2072-6694
Publisher
MDPI AG
Volume
14
Issue
3
Language
eng
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Zijlstra, J. M., Follows, G., Casasnovas, R., Vermaat, J. S., Kalakonda, N., Choquet, S., Hill, B., et al. (2022). The Association between Patient Characteristics and the Efficacy and Safety of Selinexor in Diffuse Large B-Cell Lymphoma in the SADAL Study.. Cancers (Basel), 14 (3) https://doi.org/10.3390/cancers14030791
Abstract
Selinexor, an oral selective inhibitor of nuclear export, was evaluated in the Phase 2b SADAL study in patients with diffuse large B-cell lymphoma (DLBCL) who previously received two to five prior systemic regimens. In post hoc analyses, we analyzed several categories of patient characteristics (age, renal function, DLBCL subtype, absolute lymphocyte count, transplant status, number of prior lines of therapy, refractory status, Ann Arbor disease stage, and lactate dehydrogenase) at baseline, i.e., during screening procedures, to determine their potential contributions to the efficacy (overall response rate [ORR], duration of response [DOR], overall survival [OS]) and tolerability of selinexor. Across most categories of characteristics, no significant difference was observed in ORR or DOR. OS was significantly longer for patients < 65 vs. ≥ 65 years, and for those with lymphocyte counts ≥ 1000/µL vs. < 1000/µL or lactate dehydrogenase ≤ ULN vs. > ULN. The most common adverse events (AEs) across the characteristics were thrombocytopenia and nausea, and similar rates of grade 3 AEs and serious AEs were observed. With its oral administration, novel mechanism of action, and consistency in responses in heavily pretreated patients, selinexor may help to address an important unmet clinical need in the treatment of DLBCL.
Keywords
Diffuse Large B-cell Lymphoma, Exportin 1, Selinexor, Sadal Study
Identifiers
35159058, PMC8834328
External DOI: https://doi.org/10.3390/cancers14030791
This record's URL: https://www.repository.cam.ac.uk/handle/1810/335207
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