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

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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Specific Immunotherapy in Advanced Cervical-Uterine Cancer Using Humanized Monoclonal Antibody Nimotuzumab and CIMAvax-EGF<sup>®</sup>Therapeutic Vaccine

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Journal of Cancer Therapy 2021年第3期12卷 146-156页

作者： Raiza Ruiz-Lorente Sayly Alfonso Eduardo Santiesteban Yamilka Sánchez Kirenia Camacho Erasmo Mendoza Carmen Elena Viada Ramón Ortiz Ihosvannys Carreño mayelin troche Meylan Cepeda Ana Rosa Vals Leticia Cabrera Annia Gorte Delmis Batista Milagros Domenech Yanela Santiesteban Yuliannis Santiesteban Daymys Estevez Jessica García-Viamontes Conrado Ramos Mico Mayra Ramos-Suzarte González Coro Hospital La Habana Cuba Celestino Hernández Robau Hospital Villa Clara Cuba Jose Ramón Lopez Tabranes Hospital Matanzas Cuba III Congreso Hospital Pinar del Río Cuba Faustino Perez Hospital Matanzas Cuba Center of Molecular Immunology Havana Cuba

Cervical uterine cancer represents the fourth most common malignant neoplasm worldwide in the female sex in terms of incidence, principally from epithelial origen. The high expression of EGFR in this tumor leads to the search for therapeutic alternatives. An Expanded Access Clinical Program was carried out in parallel groups, randomized, multicenter and prospective study, to evaluate the survival of patients with advanced cervical carcinoma, without therapeutic alternative, who would be treated with the therapeutic vaccine CIMAvax-EGF®, the humanized mAb nimotuzumab or the combination of both products, which targeted EGF and EGFR respectively. The patients were included between 2008 and 2010 with a more than five years follow-up. The results show that the serious adverse events related to the experimental treatments were 0.9%;1.1% and 2.6% and a medi

关键词： CIMAvax-EGF® Nimotuzumab Survival Safety Advanced Cervical Cancer

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