Ixazomib Versus Placebo as Postinduction Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients: An Analysis by Age and Frailty Status of the TOURMALINE-MM4 Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F23%3A00078011" target="_blank" >RIV/65269705:_____/23:00078011 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S2152265023000939?pes=vor" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2152265023000939?pes=vor</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.clml.2023.03.007" target="_blank" >10.1016/j.clml.2023.03.007</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Ixazomib Versus Placebo as Postinduction Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients: An Analysis by Age and Frailty Status of the TOURMALINE-MM4 Study

Popis výsledku v původním jazyce

This TOURMALINE-MM4 secondary analysis was performed to determine if the progression-free survival (PFS) benefit observed in newly-diagnosed multiple myeloma (NDMM) patients with maintenance ixazomib versus placebo was driven by a particular subgroup of patients. PFS benefit with ixazomib versus placebo was seen across all age and frailty status subgroups. Ixazomib prolonged PFS across the heterogeneous population of NDMM patients. Background: The TOURMALINE-MM4 trial demonstrated a significant and clinically meaningful progression-free survival (PFS) benefit with ixazomib versus placebo as postinduction maintenance in nontransplant, newly-diagnosed multiple myeloma patients, with a manageable and well-tolerated toxicity profile. Materials and Methods: In this subgroup analysis, efficacy and safety were assessed by age ( &lt; 65, 65-74, and = 75 years) and frailty status (fit, intermediate-fit, and frail). Results: In this analysis, PFS benefit with ixazomib versus placebo was seen across age subgroups, including patients aged &lt; 65 years (hazard ratio [HR], 0.576; 95% confidence interval [CI], 0.299-1.108; P =.095), 65-74 years (HR, 0.615; 95% CI, 0.467-0.810; P &lt;.001), and = 75 years (HR, 0.740; 95% CI, 0.537-1.019; P =.064). PFS benefit was also seen across frailty subgroups, including fit (HR, 0.530; 95% CI, 0.387-0.727; P &lt;.001), intermediate-fit (HR, 0.746; 95% CI, 0.526-1.058; P =.098), and frail (HR, 0.733; 95% CI, 0.481-1.117; P =.147) patients. With ixazomib versus placebo, rates of grade = 3 treatment-emergent adverse events (TEAEs; 28-44% vs. 10-36%), serious TEAEs (15-29% vs. 3-29%), and discontinuation due to TEAEs (7-19% vs. 5-11%) were higher or similar across age and frailty subgroups, and generally somewhat higher in older age groups and intermediate-fit/frail patients in both arms. Treatment with ixazomib versus placebo did not adversely affect patient-reported quality-of-life scores across age and frailty status subgroups. Conclusion: Ixazomib is a feasible and effective maintenance option for prolonging PFS across this heterogeneous patient population.

Název v anglickém jazyce

Ixazomib Versus Placebo as Postinduction Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients: An Analysis by Age and Frailty Status of the TOURMALINE-MM4 Study

Popis výsledku anglicky

This TOURMALINE-MM4 secondary analysis was performed to determine if the progression-free survival (PFS) benefit observed in newly-diagnosed multiple myeloma (NDMM) patients with maintenance ixazomib versus placebo was driven by a particular subgroup of patients. PFS benefit with ixazomib versus placebo was seen across all age and frailty status subgroups. Ixazomib prolonged PFS across the heterogeneous population of NDMM patients. Background: The TOURMALINE-MM4 trial demonstrated a significant and clinically meaningful progression-free survival (PFS) benefit with ixazomib versus placebo as postinduction maintenance in nontransplant, newly-diagnosed multiple myeloma patients, with a manageable and well-tolerated toxicity profile. Materials and Methods: In this subgroup analysis, efficacy and safety were assessed by age ( &lt; 65, 65-74, and = 75 years) and frailty status (fit, intermediate-fit, and frail). Results: In this analysis, PFS benefit with ixazomib versus placebo was seen across age subgroups, including patients aged &lt; 65 years (hazard ratio [HR], 0.576; 95% confidence interval [CI], 0.299-1.108; P =.095), 65-74 years (HR, 0.615; 95% CI, 0.467-0.810; P &lt;.001), and = 75 years (HR, 0.740; 95% CI, 0.537-1.019; P =.064). PFS benefit was also seen across frailty subgroups, including fit (HR, 0.530; 95% CI, 0.387-0.727; P &lt;.001), intermediate-fit (HR, 0.746; 95% CI, 0.526-1.058; P =.098), and frail (HR, 0.733; 95% CI, 0.481-1.117; P =.147) patients. With ixazomib versus placebo, rates of grade = 3 treatment-emergent adverse events (TEAEs; 28-44% vs. 10-36%), serious TEAEs (15-29% vs. 3-29%), and discontinuation due to TEAEs (7-19% vs. 5-11%) were higher or similar across age and frailty subgroups, and generally somewhat higher in older age groups and intermediate-fit/frail patients in both arms. Treatment with ixazomib versus placebo did not adversely affect patient-reported quality-of-life scores across age and frailty status subgroups. Conclusion: Ixazomib is a feasible and effective maintenance option for prolonging PFS across this heterogeneous patient population.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

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

7

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

491-504

Kód UT WoS článku

001056161000001

EID výsledku v databázi Scopus

2-s2.0-85158824362