Subgroup analysis in RAISE: A randomized, double-blind phase 3 study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F16%3AN0000085" target="_blank" >RIV/00209805:_____/16:N0000085 - isvavai.cz</a>

Result on the web

<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5091322/" target="_blank" >https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5091322/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/annonc/mdw402" target="_blank" >10.1093/annonc/mdw402</a>

Result language

angličtina

Original language name

Subgroup analysis in RAISE: A randomized, double-blind phase 3 study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression

Original language description

The RAISE phase III clinical trial demonstrated that ramucirumab + FOLFIRI improved overall survival (OS) [hazard ratio (HR) = 0.844, P = 0.0219] and progression-free survival (PFS) (HR = 0.793, P < 0.0005) compared with placebo + FOLFIRI for second-line metastatic colorectal carcinoma (mCRC) patients previously treated with first-line bevacizumab, oxaliplatin, and a fluoropyrimidine. Since some patient or disease characteristics could be associated with differential efficacy or safety, prespecified subgroup analyses were undertaken. This report focuses on three of the most relevant ones: KRAS status (wild-type versus mutant), age (<65 versus ≥65 years), and time to progression (TTP) on firstline therapy (<6 versus ≥6 months).OS and PFS were evaluated by the Kaplan–Meier analysis, with HR determined by the Cox proportional hazards model. Treatment-by-subgroup interaction was tested to determine whether treatment effect was consistent between subgroup pairs. Patients with both wild-type and mutant KRAS benefited from ramucirumab + FOLFIRI treatment over placebo + FOLFIRI; although numerically, wild-type KRAS patients benefited more. Patients with both longer and shorter first-line TTP benefited from ramucirumab, although TTP <6 months was associated with poorer OS. The subgroups of patients ≥65 versus <65 years also derived a similar ramucirumab survival benefit. The safety profile of ramucirumab + FOLFIRI was similar across subgroups. These analyses revealed similar efficacy and safety among patient subgroups with differing KRAS mutation status, longer or shorter first-line TTP, and age. Ramucirumab is a beneficial addition to second-line FOLFIRI treatment for a wide range of patients with mCRC.

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

Annals of Oncology

ISSN

0923-7534

e-ISSN

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Volume of the periodical

27

Issue of the periodical within the volume

November

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

2082–2090

UT code for WoS article

000388528900016

EID of the result in the Scopus database

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