Association of Selinexor Dose Reductions With Clinical Outcomes in the BOSTON Study

Result code in IS VaVaI

RIV/00064165:_____/23:10472797 - isvavai.cz

Alternative codes found

RIV/00216208:11110/23:10472797

Result on the web

https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=GzdP_WPSev

DOI - Digital Object Identifier

10.1016/j.clml.2023.08.018

Result language

angličtina

Original language name

Association of Selinexor Dose Reductions With Clinical Outcomes in the BOSTON Study

Original language description

Efficacy and tolerability data of 195 patients with relapsed/refractory multiple myeloma who were randomized to once-weekly selinexor (100 mg), once-weekly subcutaneous bortezomib, and twice-weekly dexamethasone in the BOSTON study were compared between patients who had selinexor dose reductions (n = 126) and those who did not (n = 69). Selinexor dose reduction was associated with longer progression-free survival, better overall response, lower duration-adjusted adverse event rates and improved quality of life. Background: Dose modifications in response to adverse events (AEs) can maintain tumor response and improve therapy tolerability. We conducted a post-hoc analysis of the efficacy and safety of reduced selinexor doses in the BOSTON trial (NCT03110562). Patients and Methods: Efficacy, safety, and quality of life (QoL) in 195 patients with relapsed/refractory multiple myeloma randomized to once-weekly (QW) selinexor (100 mg), QW subcutaneous bortezomib (1.3 mg/m2), and twice-weekly dexamethasone (20 mg) were compared between patients with dose reductions and those without. Results: In total, 126 patients (65%) had selinexor dose reductions (median dose 71.4 mg/wk). In patients with dose reductions versus those without median progression-free survival was 16.6 months (95% CI 12.9-not evaluable [NE]) versus 9.2 months [95% CI 6.8-15.5]), overall response rate was 81.7% (95% CI 73.9-88.1%) versus 66.7% (95% CI 54.3-77.6%), >= very good partial response was (51.6% [95% CI 42.5-60.6%] vs. 31.9% [95% CI 21.244.2]), median duration of response was not reached (95% CI 13.8-NE) versus 12.0 months (95% CI 8.3-NE), and time to next treatment was 22.6 months (95% CI 14.6-NE) versus 10.5 months (95% CI 6.3-18.2). Mean best change from baseline on the EORTC QLQ-C30 Global Health Status/QoL scale was 10.0 +/- 20.5 versus 4.0 +/- 20.9. Duration adjusted AE rates that were lower after selinexor dose reduction included thrombocytopenia (62.5% before vs. 47.6% after), nausea (31.6% vs. 7.3%), fatigue (28.1% vs. 9.9%), decreased appetite (21.5% vs. 6.4%), anemia (17.9% vs. 10.3%), and diarrhea (12.9% vs. 5.2%). Conclusion: Appropriate dose reductions in response to AEs of the 100 mg selinexor starting dose in the BOSTON study were associated with improved efficacy, reduced AE rates and improved QoL.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30205 - Hematology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Clinical Lymphoma, Myeloma & Leukemia

ISSN

2152-2650

e-ISSN

2152-2669

Volume of the periodical

23

Issue of the periodical within the volume

12

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

917-"923.e3"

UT code for WoS article

001125357500001

EID of the result in the Scopus database

2-s2.0-85171974140