Evaluación de Nimotuzumab para el tratamiento de cáncer de cabeza y cuello: Meta-análisis de ensayos controlados

Abstract

Nimotuzumab, humanized monoclonal antibody, directed against the epidermal growth factor receptor: highly expressed protein in malignant tumors of epithelial origin. It has been registered for head and neck tumors since 2002. To determine the effectiveness of Nimotuzumab in head and neck cancer through the combined meta-analysis technique. A search was conducted in PubMed, in an indexed magazine with the words “Nimotuzumab”, “head and neck,” 48 articles published by Cuban and foreign authors were detected between April 1, 2005, and July 31, 2019, in which the results of clinical studies conducted with the monoclonal antibody Nimotuzumab are described. Seven clinical trials conducted in Cuba from 2005-2019 with Nimotuzumab are described; three Phase I / II (with 14, 10 and 10 patients respectively), a Phase II / III with 106 patients, a Phase II with 37 patients, two Phase IV (with 386 and 225 patients each) and a study promoted by the Researcher with 17 patients. From these studies, the three controlled trials were selected by the PRISMA flow chart. The meta-analysis consisted of the construction of the Forest Plot graph, the sensitivity analysis and the cumulative analysis. The meta-analysis shows favorable results for Nimotuzumab, without heterogeneity (I2 = 0%). The sensitivity analysis reveals that the test that differs most from the others is Phase II / III. The cumulative analysis indicates that after the second trial, there is already sufficient evidence.