Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F24%3A00080273" target="_blank" >RIV/65269705:_____/24:00080273 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/24:00136791 RIV/00216208:11110/24:10483341 RIV/00064165:_____/24:10483341

Výsledek na webu

<a href="https://haematologica.org/article/view/haematol.2023.284635" target="_blank" >https://haematologica.org/article/view/haematol.2023.284635</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3324/haematol.2023.284635" target="_blank" >10.3324/haematol.2023.284635</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

Popis výsledku v původním jazyce

Relapsed or refractory multiple myeloma (RRMM) is associated with severe symptoms, some of which have been strongly linked to impairments in health-related quality of life (HRQoL), notably pain, fatigue, and a decline in physical and emotional functioning.1 Furthermore, HRQoL deteriorates with each subsequent line of therapy in RRMM.2 Hence, treatment goals, particularly in later lines of therapy, should include preserving HRQoL. Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that utilizes increased peptidase expression to selectively release potent alkylating agents inside tumor cells. Melflufen is approved in Europe for the treatment of patients with triple-class refractory RRMM with GREATER-THAN OR EQUAL TO3 prior lines of therapy and time to progression (TTP) &gt;36 months after prior autologous stem cell transplant (ASCT), if received. Approval was based on the results of the phase II HORIZON study and further supported by those of the phase III OCEAN study.3-5 OCEAN met its primary endpoint with melflufen plus dexamethasone demonstrating superior progression-free survival compared with pomalidomide plus dexamethasone in RRMM.4 Across trials, the safety profile of melflufen plus dexamethasone has been characterized primarily by hematologic adverse events that are clinically manageable, with infrequent grade 3/4 non-hematologic adverse events.3,4,6 HRQoL over time was preserved with melflufen plus dexamethasone in patients with advanced RRMM in the HORIZON trial..7 Pomalidomide plus dexamethasone has also been shown to be safe and effective without negatively affecting HRQoL, including in later lines of therapy.8 In this letter, we report HRQoL based on patient-reported outcomes (PRO) in a subset of patients from OCEAN receiving either melflufen plus dexamethasone or pomalidomide plus dexamethasone. Overall, melflufen plus dexamethasone treatment resulted in HRQoL comparable to that of pomalidomide plus dexamethasone, further supporting the use of melflufen plus dexamethasone in heavily pretreated patients with RRMM.

Název v anglickém jazyce

Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

Popis výsledku anglicky

Relapsed or refractory multiple myeloma (RRMM) is associated with severe symptoms, some of which have been strongly linked to impairments in health-related quality of life (HRQoL), notably pain, fatigue, and a decline in physical and emotional functioning.1 Furthermore, HRQoL deteriorates with each subsequent line of therapy in RRMM.2 Hence, treatment goals, particularly in later lines of therapy, should include preserving HRQoL. Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that utilizes increased peptidase expression to selectively release potent alkylating agents inside tumor cells. Melflufen is approved in Europe for the treatment of patients with triple-class refractory RRMM with GREATER-THAN OR EQUAL TO3 prior lines of therapy and time to progression (TTP) &gt;36 months after prior autologous stem cell transplant (ASCT), if received. Approval was based on the results of the phase II HORIZON study and further supported by those of the phase III OCEAN study.3-5 OCEAN met its primary endpoint with melflufen plus dexamethasone demonstrating superior progression-free survival compared with pomalidomide plus dexamethasone in RRMM.4 Across trials, the safety profile of melflufen plus dexamethasone has been characterized primarily by hematologic adverse events that are clinically manageable, with infrequent grade 3/4 non-hematologic adverse events.3,4,6 HRQoL over time was preserved with melflufen plus dexamethasone in patients with advanced RRMM in the HORIZON trial..7 Pomalidomide plus dexamethasone has also been shown to be safe and effective without negatively affecting HRQoL, including in later lines of therapy.8 In this letter, we report HRQoL based on patient-reported outcomes (PRO) in a subset of patients from OCEAN receiving either melflufen plus dexamethasone or pomalidomide plus dexamethasone. Overall, melflufen plus dexamethasone treatment resulted in HRQoL comparable to that of pomalidomide plus dexamethasone, further supporting the use of melflufen plus dexamethasone in heavily pretreated patients with RRMM.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

Haematologica

ISSN

0390-6078

e-ISSN

1592-8721

Svazek periodika

109

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

IT - Italská republika

Počet stran výsledku

6

Strana od-do

2331-2336

Kód UT WoS článku

001263361100038

EID výsledku v databázi Scopus

2-s2.0-85197958507