First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F18%3A00070314" target="_blank" >RIV/65269705:_____/18:00070314 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1007/s10549-017-4658-x" target="_blank" >http://dx.doi.org/10.1007/s10549-017-4658-x</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s10549-017-4658-x" target="_blank" >10.1007/s10549-017-4658-x</a>

Jazyk výsledku

angličtina

Název v původním jazyce

First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial

Popis výsledku v původním jazyce

Purpose The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL). Methods Postmenopausal women (N = 668) with HR+, HER2-ABC and no prior systemic therapy for ABC were randomized to RIB (600 mg/day; 3 weeks on/1 week off) plus LET (2.5 mg/day; continuous) or placebo (PBO) plus LET. Primary end point was PFS; HRQoL was the secondary end point; DoR was exploratory end point and PFS by TFI was post hoc analysis. Results Of 501 pts with measurable disease and confirmed complete or partial response, median DoR was 26.7 months (95% CI, 24.0-NR) in the RIB arm versus 18.6 months (95% CI, 14.8-23.1) in the PBO arm. At 8 weeks, more pts in the RIB arm (32%) versus the PBO arm (17%) experienced best percentage change &gt;= 60%. The average pain reduction was greater in the RIB arm (26%) versus the PBO arm (15%). PFS benefit was seen with RIB vs PBO, irrespective of TFI. Conclusion RIB plus LET versus PBO plus LET is associated with earlier and more durable tumor response, greater degree of tumor shrinkage and pain reduction, and PFS benefit irrespective of TFI. These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+, HER2-ABC.

Název v anglickém jazyce

First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial

Popis výsledku anglicky

Purpose The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL). Methods Postmenopausal women (N = 668) with HR+, HER2-ABC and no prior systemic therapy for ABC were randomized to RIB (600 mg/day; 3 weeks on/1 week off) plus LET (2.5 mg/day; continuous) or placebo (PBO) plus LET. Primary end point was PFS; HRQoL was the secondary end point; DoR was exploratory end point and PFS by TFI was post hoc analysis. Results Of 501 pts with measurable disease and confirmed complete or partial response, median DoR was 26.7 months (95% CI, 24.0-NR) in the RIB arm versus 18.6 months (95% CI, 14.8-23.1) in the PBO arm. At 8 weeks, more pts in the RIB arm (32%) versus the PBO arm (17%) experienced best percentage change &gt;= 60%. The average pain reduction was greater in the RIB arm (26%) versus the PBO arm (15%). PFS benefit was seen with RIB vs PBO, irrespective of TFI. Conclusion RIB plus LET versus PBO plus LET is associated with earlier and more durable tumor response, greater degree of tumor shrinkage and pain reduction, and PFS benefit irrespective of TFI. These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+, HER2-ABC.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Breast Cancer Research and Treatment

ISSN

0167-6806

e-ISSN

—

Svazek periodika

169

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

469-479

Kód UT WoS článku

000432317800008

EID výsledku v databázi Scopus

2-s2.0-85045047244