INSPIRE: A phase III study of the BLP25 liposome vaccine L-BLP25 in Asian patients with unresectable stage III non-small cell lung cancerReportar como inadecuado




INSPIRE: A phase III study of the BLP25 liposome vaccine L-BLP25 in Asian patients with unresectable stage III non-small cell lung cancer - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Cancer

, 11:430

First Online: 07 October 2011Received: 11 May 2011Accepted: 07 October 2011DOI: 10.1186-1471-2407-11-430

Cite this article as: Wu, YL., Park, K., Soo, R.A. et al. BMC Cancer 2011 11: 430. doi:10.1186-1471-2407-11-430

Abstract

BackgroundPrevious research suggests the therapeutic cancer vaccine L-BLP25 potentially provides a survival benefit in patients with locally advanced unresectable stage III non-small cell lung carcinoma NSCLC. These promising findings prompted the phase III study, INSPIRE, in patients of East-Asian ethnicity. East-Asian ethnicity is an independent favourable prognostic factor for survival in NSCLC. The favourable prognosis is most likely due to a higher incidence of EGFR mutations among this patient population.

Methods-designThe primary objective of the INSPIRE study is to assess the treatment effect of L-BLP25 plus best supportive care BSC, as compared to placebo plus BSC, on overall survival time in East-Asian patients with unresectable stage III NSCLC and either documented stable disease or an objective response according to the Response Evaluation Criteria in Solid Tumors RECIST criteria following primary chemoradiotherapy. Those in the L-BLP25 arm will receive a single intravenous infusion of cyclophosphamide 300 mg-m 3 days before the first L-BLP25 vaccination, with a corresponding intravenous infusion of saline to be given in the control arm. A primary treatment phase of 8 subcutaneous vaccinations of L-BLP25 930 μg or placebo at weekly intervals will be followed by a maintenance treatment phase of 6-weekly vaccinations continued until disease progression or discontinuation from the study.

DiscussionThe ongoing INSPIRE study is the first large study of a therapeutic cancer vaccine specifically in an East-Asian population. It evaluates the potential of maintenance therapy with L-BLP25 to prolong survival in East-Asian patients with stage III NSCLC where there are limited treatment options currently available.

Study numberEMR 63325-012

Trial RegistrationClinicaltrials.gov reference: NCT01015443

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-11-430 contains supplementary material, which is available to authorized users.

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Autor: Yi-Long Wu - Keunchil Park - Ross A Soo - Yan Sun - Karin Tyroller - David Wages - Guy Ely - James Chih-Hsin Yang - Tony

Fuente: https://link.springer.com/







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