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Evaluation of racotumomab for the treatment of lung cancer: Meta-analysis of controlled trials of the CIM

Abstract:

Racotumomab is a therapeutic cancer vaccine entirely developed in Cuba and licensed in the country for use in adult patients with non-small cell lung cancer (NSCLC) in stages IIIB / IV. To determine the effectiveness of the Racotumomab vaccine through the combined meta-analysis technique. A PubMed search was made of "Racotumomab", "Vaxira", "anti-idiotypic vaccine", 20 articles published by Cuban authors were obtained between January 1, 1997 and September 30, 2017, where the results are described of the clinical studies conducted during the development of Racotumomab, mainly those published by Cuban researchers in peer-reviewed international scientific journals. The articles describe seven clinical trials conducted in Cuba from 1997-2017 with Racotumomab; a Phase I with 71 patients, two Phase II with 72 and 176 patients respectively, two Phase III with 273 and 378 patients respectively, an expanded access program with 200 patients and a study promoted by the researcher with 19 patients. Of these studies, three controlled and randomized trials were selected according to the PRISMA criteria. The meta-analysis consisted in the construction of the Forest Plot graphic, the sensitivity analysis and the accumulated analysis. The meta-analysis shows favorable results for the Racotumomab vaccine with a combined HR of 0.77. The sensitivity analysis reveals that the most important trial was the EC080 Phase II. The cumulative analysis indicates that the study that contributes the least to the meta-analysis was the last one included.