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CIMAvax^(█)EGF vaccine therapy for non-small cell lung cancer:A weighted log-rank tests-based evaluation

Modern Chemotherapy 2013年第3期2卷 51-56页

作者： Carmen Viada Gonzalez Jean-Francois Dupuy martha fors lópez Patricia lorenzo luaces Gisela González Marinello Elia Neninger Vinagera Beatriz García Verdecia Tania Crombet-Ramos Clinical Trials Department Center of Molecular ImmunologyHavanaCuba National Institute of Applied Sciences of Rennes RennesFrance National Coordinator Center of Clinical Trial HavanaCuba Hermanos Ameijeiras Hospital HavanaCuba

Time-to-event has become one of the primary endpoints of many clinical trials. Comparing treatments and therapies using time-to-event (or “survival”) data requires some care, since survival differences may occur either early or late in the follow-up period, depending on various factors such as the initial potency or the duration of efficacy of the drugs. In this work, we investigate the effect of the CIMAvax?EGF vaccine therapy on the survival of patients with non-small cell lung cancer, using stratified and unstratified weighted log-rank tests. Weighted log-rank tests are designed to identify early and late survival differences between treatments. Using these tests, we conclude that the vaccine is more efficient than the standard therapy among patients less than 60 years of age.

关键词： log-Rank Test Fleming-Harrington Test Stratified Tests

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Stratified Cox Regression Analysis of Survival under CIMAvax^(■)EGF Vaccine

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Journal of Cancer Therapy 2013年第8期4卷 8-14页

作者： Carmen Viada Gonzalez Jean-Francois Dupuy martha fors lópez Patricia lorenzo luaces Camilo Rodríguez Rodríguez Gisela González Marinello Elia Neninger Vinagera Beatriz García Verdecia Bárbara Wilkinson Brito liana Martínez Pérez Mayelin Troche de la Concepción Tania Crombet-Ramos Center of Molecular Immunology HavanaCuba Institut National des Sciences Appliquées de Rennes RennesFrance National Coordinator Center of Clinical Trial HavanaCuba Hermanos Ameijeiras Hospital HavanaCuba

Background: The Center of Molecular Immunology (CIM) is a center in Cuba devoted to the research, development and manufacturing of biotechnological products. CIMAvax?EGF is a vaccine for the treatment of non-small cell lung cancer patients (NSCl). Purpose: The aim of this work is to evaluate the effects of some potential prognostic factors on the overall survival of patients treated with CIMAvax?EGF vaccine, based on data collected in a phase II and a phase III clinical trials. Methods: The stratified Cox regression model is used to evaluate the effects of these prognostic factors, based on separate analysis for each trial, and on the combined data from both trials. Results: Patients with Performance status 0 or 1, with IV stage of tumor and male under 60 years obtain more benefit in terms of overall survival if they receive CIMAvax?EGF. Conclusions: Vaccinated group has a better performance if patients have a performance status 0 or 1, stage IV and age under 60 years. These prognostic factors influence overall survival in a positive way for those patients that received CIMAvax?EGF.

关键词： Stratified Cox Regression Model Risk Factor Non-Small lung Cancer Censored Data

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