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

Result code in 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>

Alternative codes found

RIV/00216224:14110/16:00092545

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FD - Oncology and haematology

OECD FORD branch

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Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2016

Confidentiality

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

Name of the periodical

Lancet

ISSN

0140-6736

e-ISSN

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Volume of the periodical

387

Issue of the periodical within the volume

10022

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

968-977

UT code for WoS article

000371644200030

EID of the result in the Scopus database

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