Phase III Trial Comparing Vinflunine With Docetaxel in Second-Line Advanced Non-Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F10%3A00002802" target="_blank" >RIV/00216208:11120/10:00002802 - isvavai.cz</a>

Result on the web

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DOI - Digital Object Identifier

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Result language

angličtina

Original language name

Phase III Trial Comparing Vinflunine With Docetaxel in Second-Line Advanced Non-Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy

Original language description

To compare vinflunine (VFL) to docetaxel in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC) who have experienced treatment failure with first-line platinum-based chemotherapy. Randomized, multicenter, phase III study, 551 patients receivedeither vinflunine 320 mg/m2 or docetaxel 75 mg/m2 every 21 days until disease progression or serious toxicity. The primary end point was progression-free survival (PFS). The noninferiority analysis was based on a 10% difference (types I/II error rates:5%/20%). Secondary end points included response rate (ORR), response duration, overall survival (OS), clinical benefit, quality of life (QOL), and safety. This noninferiority phase III study showed similar efficacy end points for vinflunine and docetaxel. Despite higher rates of some adverse effects (anemia, abdominal pain, constipation, fatigue) the overall toxicity profile of vinflunine was manageable. Therefore, VFL may be another option in the second-line treatment of patients with a

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

AQ - Safety and health protection, safety in operating machinery

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2010

Confidentiality

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

Name of the periodical

Journal of Clinical Oncology

ISSN

0732-183X

e-ISSN

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Volume of the periodical

28

Issue of the periodical within the volume

13

Country of publishing house

US - UNITED STATES

Number of pages

7

Pages from-to

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UT code for WoS article

000277180300009

EID of the result in the Scopus database

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