Nintedanib for the treatment of patients win refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized placebo-controlled study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F18%3A00078062" target="_blank" >RIV/00209805:_____/18:00078062 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1093/annonc/mdy241" target="_blank" >http://dx.doi.org/10.1093/annonc/mdy241</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/annonc/mdy241" target="_blank" >10.1093/annonc/mdy241</a>

Result language

angličtina

Original language name

Nintedanib for the treatment of patients win refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized placebo-controlled study

Original language description

Background: Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies. Patients and methods: Eligible patients (Eastern Cooperative Oncology Group performance status 0-1, with histologically/cytologically confirmed metastatic/locally advanced CRC adenocarcinoma unamenable to surgery and/or radiotherapy) were randomized 1 :1 to receive nintedanib (200 mg twice daily) or placebo (twice daily), until disease progression or undue toxicity. Patients were stratified by previous regorafenib, time from onset of metastatic disease to randomization, and region. Co-primary end points were overall survival (OS) and progression-free survival (PFS) by central review. Secondary end points included objective tumor response and disease control by central review. Results: From October 2014 to January 2016, 768 patients were randomized; 765 were treated (nintedanib n = 384; placebo n= 381). Median follow-up was 13.4 months (interquartile range 11.1-15.7). OS was not improved [median OS 6.4 months with nintedanib versus 6.0 months with placebo; hazard ratio (HR), 1.01; 95% confidence interval (CI), 0.86-1.19; P= 0.8659]. There was a significant but modest increase in PFS with nintedanib versus placebo (median PFS 1.5 versus 1.4 months, respectively; HR 058; 95% CI 0A9-0.69; P &lt; 0.0001). There were no complete or partial responses. Adverse events (AEs) occurred in 97% of 384 nintedanib-treated patients and 93% of 381 placebo-treated patients. The most frequent grade &gt;= 3 AEs were liver-related AEs (nintedanib 16%; placebo 8%) and fatigue (nintedanib 9%; placebo 6%). Conclusions: The study failed to meet both co-primary end points. Nintedanib did not improve OS and was associated with a significant but modest increase in PFS versus placebo. Nintedanib was well tolerated.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30204 - Oncology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

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

Name of the periodical

Annals of oncology

ISSN

0923-7534

e-ISSN

—

Volume of the periodical

29

Issue of the periodical within the volume

9

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

1955-1963

UT code for WoS article

000446087800013

EID of the result in the Scopus database

2-s2.0-85054331573