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Randomized phase III trial comparing bexarotene (L106949)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F08%3A00001291" target="_blank" >RIV/00216208:11120/08:00001291 - isvavai.cz</a>

  • Alternative codes found

    RIV/00064211:_____/08:#0000031

  • Result on the web

  • DOI - Digital Object Identifier

Alternative languages

  • Result language

    angličtina

  • Original language name

    Randomized phase III trial comparing bexarotene (L106949)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I

  • Original language description

    Purpose: This study evaluated whether the combination of the synthetic rexinoid bexarotene with first-line cisplatin/vinorelbine therapy provides additional survival benefit in patients with advanced non small-cell lung cancer (NSCLC). Patients and Methods: Patients with stage IIIB with pleural effusion or stage IV NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to open-label bexarotene 400 mg/m(2)/d with cisplatin/vinorelbine or to cisplatin/vinorelbine alone. Antilipid agents were initiated on or before day 1 in the bexarotene arm. Primary efficacy end point was overall survival. Primary, secondary and supportive efficacy analyses were conducted. Results: A total of 623 patients (312 control, 311 bexarotene) were enrolled. Overall, no significant difference in survival occurred between the two treatment groups. However, an unplanned retrospective analysis showed that a subpopulation of bexarotene patients (n = 98 of 306) who experienced N

  • Czech name

    Randomizovaná studie III. fáze srovnávající bexarotene (L106949)/cisplatina/vinorelbin s režimem cisplatina/vinorelbin u chemoterapií nepředléčených pacientů s pokročilým nebo metastazujícím nemalobuněčným karcinomem plic. SPIRIT I

  • Czech description

    Randomizovaná studie III. fáze srovnávající bexarotene (L106949)/cisplatina/vinorelbin s režimem cisplatina/vinorelbin u chemoterapií nepředléčených pacientů s pokročilým nebo metastazujícím nemalobuněčným karcinomem plic. SPIRIT I

Classification

  • Type

    J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

  • CEP classification

    FC - Pneumology

  • OECD FORD branch

Result continuities

  • Project

  • Continuities

    Z - Vyzkumny zamer (s odkazem do CEZ)

Others

  • Publication year

    2008

  • Confidentiality

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

Data specific for result type

  • Name of the periodical

    Journal of Clinical Oncology

  • ISSN

    0732-183X

  • e-ISSN

  • Volume of the periodical

    26

  • Issue of the periodical within the volume

    11

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    7

  • Pages from-to

  • UT code for WoS article

    000255054600020

  • EID of the result in the Scopus database