Use via early access to ixazomib (UVEA-IXA) study: effectiveness and safety of ixazomib-based therapy in relapsed/refractory multiple myeloma outside of the clinical trial setting

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F24%3AE0110795" target="_blank" >RIV/00843989:_____/24:E0110795 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61988987:17110/24:A25039NE

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S2152265023021481?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2152265023021481?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.clml.2023.10.003" target="_blank" >10.1016/j.clml.2023.10.003</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Use via early access to ixazomib (UVEA-IXA) study: effectiveness and safety of ixazomib-based therapy in relapsed/refractory multiple myeloma outside of the clinical trial setting

Popis výsledku v původním jazyce

Background: In multiple myeloma (MM), improving our understanding of routine clinical practice and the effectiveness of agents outside of clinical trials is important. TOURMALINE-MM1 data resulted in approval of ixazomib for MM patients who have received ? 1 prior therapy. Patients and methods: UVEA-IXA comprised a retrospective chart review in the early access program, and a prospective 1-year follow-up period. Eligible patients had had a biochemical and/or symptomatic relapse after 1-3 prior lines of therapy; no anti-MM therapy for > 3 cycles at the start of ixazomib therapy; and an Eastern Cooperative Oncology Group performance score of 0-2. Lenalidomide- or proteasome inhibitor (PI)-refractory patients were ineligible. Primary endpoints were response and progression-free survival (PFS). Results: Of 357 enrolled patients, 309 were evaluable; most patients received ixazomib alongside lenalidomide (98%) and dexamethasone (97%); 61% had received 2-3 prior lines of therapy. Median PFS was 15.6 months (95% confidence interval [CI]: 12.0-20.6) in all evaluable patients, and 19.6 (95% CI: 12.1-27.0) and 13.9 (95% CI: 10.1-18.1) months in patients who received 1 and ? 2 prior lines of therapy, respectively. The overall response rate was 67% in all evaluable patients, and 72% and 63%, respectively, in patients who received 1 and ? 2 prior lines of therapy. Median overall survival was 35.5 months. The ixazomib safety profile was consistent with previous reports. Conclusion: This study supports ixazomib-based therapy as an effective and tolerable treatment in the real-world. Outcomes were favorable in patients with 1 or ? 2 prior lines of therapy who were not lenalidomide- or PI-refractory.

Název v anglickém jazyce

Use via early access to ixazomib (UVEA-IXA) study: effectiveness and safety of ixazomib-based therapy in relapsed/refractory multiple myeloma outside of the clinical trial setting

Popis výsledku anglicky

Background: In multiple myeloma (MM), improving our understanding of routine clinical practice and the effectiveness of agents outside of clinical trials is important. TOURMALINE-MM1 data resulted in approval of ixazomib for MM patients who have received ? 1 prior therapy. Patients and methods: UVEA-IXA comprised a retrospective chart review in the early access program, and a prospective 1-year follow-up period. Eligible patients had had a biochemical and/or symptomatic relapse after 1-3 prior lines of therapy; no anti-MM therapy for > 3 cycles at the start of ixazomib therapy; and an Eastern Cooperative Oncology Group performance score of 0-2. Lenalidomide- or proteasome inhibitor (PI)-refractory patients were ineligible. Primary endpoints were response and progression-free survival (PFS). Results: Of 357 enrolled patients, 309 were evaluable; most patients received ixazomib alongside lenalidomide (98%) and dexamethasone (97%); 61% had received 2-3 prior lines of therapy. Median PFS was 15.6 months (95% confidence interval [CI]: 12.0-20.6) in all evaluable patients, and 19.6 (95% CI: 12.1-27.0) and 13.9 (95% CI: 10.1-18.1) months in patients who received 1 and ? 2 prior lines of therapy, respectively. The overall response rate was 67% in all evaluable patients, and 72% and 63%, respectively, in patients who received 1 and ? 2 prior lines of therapy. Median overall survival was 35.5 months. The ixazomib safety profile was consistent with previous reports. Conclusion: This study supports ixazomib-based therapy as an effective and tolerable treatment in the real-world. Outcomes were favorable in patients with 1 or ? 2 prior lines of therapy who were not lenalidomide- or PI-refractory.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

Clinical Lymphoma, Myeloma & Leukemia

ISSN

2152-2650

e-ISSN

2152-2669

Svazek periodika

24

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

1

Strana od-do

e40-e49.e3

Kód UT WoS článku

001171323500001

EID výsledku v databázi Scopus

2-s2.0-85178208181