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

Kód výsledku v 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>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

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

Popis výsledku anglicky

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

Druh

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

CEP obor

AQ - Bezpečnost a ochrana zdraví, člověk – stroj

OECD FORD obor

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Projekt

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Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2010

Kód důvěrnosti údajů

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

Název periodika

Journal of Clinical Oncology

ISSN

0732-183X

e-ISSN

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Svazek periodika

28

Číslo periodika v rámci svazku

13

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

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Kód UT WoS článku

000277180300009

EID výsledku v databázi Scopus

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