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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F23%3A10472797" target="_blank" >RIV/00064165:_____/23:10472797 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/23:10472797

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=GzdP_WPSev" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=GzdP_WPSev</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.clml.2023.08.018" target="_blank" >10.1016/j.clml.2023.08.018</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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%), &gt;= 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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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%), &gt;= 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

Clinical Lymphoma, Myeloma &amp; Leukemia

ISSN

2152-2650

e-ISSN

2152-2669

Svazek periodika

23

Číslo periodika v rámci svazku

12

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

917-"923.e3"

Kód UT WoS článku

001125357500001

EID výsledku v databázi Scopus

2-s2.0-85171974140