Stratified Cox Regression Analysis of Survival under CIMAvax ® EGF Vaccine

Abstract

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 potentia l prognostic factors on the overall survival of pa tients 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 tria l, and on the combined data from both trials. Results: Patients with Per- formance status 0 or 1, with IV stage of tumor and male unde r 60 years obtain more benefit in terms of overall survival if they receive CIMAvax ® EGF. Conclusions: Vaccinated group has a better perfor mance if patients have a perform- ance status 0 or 1, stage IV and age und er 60 years. These prognostic factors in fluence overall survival in a positive way for those patients that received CIMAvax ® EGF. Keywords: Stratified Cox Regression Model; Risk Factor; Non-Small Lung Cancer; Censored Data