Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F16%3AN0000064" target="_blank" >RIV/00209805:_____/16:N0000064 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1609709" target="_blank" >http://www.nejm.org/doi/full/10.1056/NEJMoa1609709</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/NEJMoa1609709" target="_blank" >10.1056/NEJMoa1609709</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

Popis výsledku v původním jazyce

The inhibition of CDK4/6 could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor and negative for HER2. In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer. We randomly assigned the patients to receive either ribociclib (600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per day) or placebo plus letrozole. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Prespecified criteria for superiority required a hazard ratio of 0.56 or less with P<1.29×10-5. The duration of progression-free survival was significantly longer in the ribociclib group than in the placebo group (hazard ratio, 0.56; 95% CI, 0.43 to 0.72; P=3.29×10-6 for superiority). The median duration of follow-up was 15.3 months. After 18 months, the progression-free survival rate was 63.0% (95% CI, 54.6 to 70.3) in the ribociclib group and 42.2% (95% CI, 34.8 to 49.5) in the placebo group. In patients with measurable disease at baseline, the overall response rate was 52.7% and 37.1%, respectively (P<0.001). Common grade 3 or 4 adverse events that were reported in more than 10% of the patients were neutropenia (59.3% in the ribociclib group vs. 0.9% in the placebo group) and leukopenia (21.0% vs. 0.6%); the rates of discontinuation because of adverse events were 7.5% and 2.1%, resp. Among patients receiving initial systemic treatment for HR-positive, HER2-negative advanced breast cancer, the duration of PFS was significantly longer among those receiving ribociclib plus letrozole vs placebo plus letrozole, with a higher rate of myelosuppression in the ribociclib group.

Název v anglickém jazyce

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

Popis výsledku anglicky

The inhibition of CDK4/6 could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor and negative for HER2. In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer. We randomly assigned the patients to receive either ribociclib (600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per day) or placebo plus letrozole. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Prespecified criteria for superiority required a hazard ratio of 0.56 or less with P<1.29×10-5. The duration of progression-free survival was significantly longer in the ribociclib group than in the placebo group (hazard ratio, 0.56; 95% CI, 0.43 to 0.72; P=3.29×10-6 for superiority). The median duration of follow-up was 15.3 months. After 18 months, the progression-free survival rate was 63.0% (95% CI, 54.6 to 70.3) in the ribociclib group and 42.2% (95% CI, 34.8 to 49.5) in the placebo group. In patients with measurable disease at baseline, the overall response rate was 52.7% and 37.1%, respectively (P<0.001). Common grade 3 or 4 adverse events that were reported in more than 10% of the patients were neutropenia (59.3% in the ribociclib group vs. 0.9% in the placebo group) and leukopenia (21.0% vs. 0.6%); the rates of discontinuation because of adverse events were 7.5% and 2.1%, resp. Among patients receiving initial systemic treatment for HR-positive, HER2-negative advanced breast cancer, the duration of PFS was significantly longer among those receiving ribociclib plus letrozole vs placebo plus letrozole, with a higher rate of myelosuppression in the ribociclib group.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

The New England journal of medicine

ISSN

0028-4793

e-ISSN

—

Svazek periodika

375

Číslo periodika v rámci svazku

18

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

1738-1748

Kód UT WoS článku

000387007300007

EID výsledku v databázi Scopus

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