Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F16%3AN0000100" target="_blank" >RIV/00209805:_____/16:N0000100 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/16:00092545

Výsledek na webu

<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00817-X/fulltext" target="_blank" >http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00817-X/fulltext</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(15)00817-X" target="_blank" >10.1016/S0140-6736(15)00817-X</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study

Popis výsledku v původním jazyce

Effective systemic therapies for patients with advanced, progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce. We aimed to assess the efficacy and safety of everolimus compared with placebo. In the randomised, double-blind, placebo-controlled, phase 3 RADIANT-4 trial, adult patients with advanced, progressive, well-differentiated, non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries. Eligible patients were randomly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo. Patients were stratified by tumour origin, performance status, and previous somatostatin analogue treatment. The primary endpoint was PFS assessed by central radiology review, analysed by intention to treat. Overall survival was a key secondary endpoint. A total of 302 patients were enrolled, of whom 205 were allocated to everolimus 10 mg per day and 97 to placebo. Median PFS was 11·0 months (95% CI 9·2-13·3) in the everolimus group and 3·9 months (3·6-7·4) in the placebo group. Everolimus was associated with a 52% reduction in the estimated risk of progression or death (hazard ratio [HR] 0·48 [95% CI 0·35-0·67], p<0·00001). The results of the first pre-planned interim OS analysis indicated that everolimus might be associated with a reduction in the risk of death (HR 0·64 [95% CI 0·40-1·05], one-sided p=0·037). Grade 3 or 4 drug-related adverse events were infrequent and included stomatitis, infections, anaemia, fatigue and hyperglycaemia. Treatment with everolimus was associated with significant improvement in PFS in patients with progressive lung or gastrointestinal neuroendocrine tumours. Everolimus is the first targeted agent to show robust anti-tumour activity with acceptable tolerability across a broad range of neuroendocrine tumours, including those arising from the pancreas, lung, and gastrointestinal tract.

Název v anglickém jazyce

Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study

Popis výsledku anglicky

Effective systemic therapies for patients with advanced, progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce. We aimed to assess the efficacy and safety of everolimus compared with placebo. In the randomised, double-blind, placebo-controlled, phase 3 RADIANT-4 trial, adult patients with advanced, progressive, well-differentiated, non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries. Eligible patients were randomly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo. Patients were stratified by tumour origin, performance status, and previous somatostatin analogue treatment. The primary endpoint was PFS assessed by central radiology review, analysed by intention to treat. Overall survival was a key secondary endpoint. A total of 302 patients were enrolled, of whom 205 were allocated to everolimus 10 mg per day and 97 to placebo. Median PFS was 11·0 months (95% CI 9·2-13·3) in the everolimus group and 3·9 months (3·6-7·4) in the placebo group. Everolimus was associated with a 52% reduction in the estimated risk of progression or death (hazard ratio [HR] 0·48 [95% CI 0·35-0·67], p<0·00001). The results of the first pre-planned interim OS analysis indicated that everolimus might be associated with a reduction in the risk of death (HR 0·64 [95% CI 0·40-1·05], one-sided p=0·037). Grade 3 or 4 drug-related adverse events were infrequent and included stomatitis, infections, anaemia, fatigue and hyperglycaemia. Treatment with everolimus was associated with significant improvement in PFS in patients with progressive lung or gastrointestinal neuroendocrine tumours. Everolimus is the first targeted agent to show robust anti-tumour activity with acceptable tolerability across a broad range of neuroendocrine tumours, including those arising from the pancreas, lung, and gastrointestinal tract.

Druh

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

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

—

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

Lancet

ISSN

0140-6736

e-ISSN

—

Svazek periodika

387

Číslo periodika v rámci svazku

10022

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

968-977

Kód UT WoS článku

000371644200030

EID výsledku v databázi Scopus

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