Report of adverse events to the CIMAvax-EGF vaccine in patients with non-small cell lung cancer

Abstract

Introduction: Therapeutic vaccines for cancer are based on the induction of a specific immune response against tumor-associated antigens, and it is currently considered one of the most promising strategies for the therapy of this disease. Monitoring the adverse events is an element of great importance. Objective: To identify the adverse events associated with this therapy and classify them according to intensity. Methods: Retrospective descriptive study was carried out in patients included in a Phase IV Clinical Trial, from September 2016 to December 2019. The universe of study consisted of 37 patients evaluated, and the sample was finally 11 with cyto/histological diagnosis of non-small cell lung carcinoma in advanced stages that received treatment with CIMAvax-EGF at the oncology department of the General Hospital Capitan. Roberto Rodríguez Fernández, in Morón, Ciego de Ávila, Cuba. Results: 60 adverse events were recorded, including tremors 10 (90.9%), local manifestations at the injection site and chills 9 (81.8%), followed by arthralgia 8 (72.2%), headache 6 (54.5%) and nausea 5 (45.4%), respectively. Most of the events were mild (48 in total), and the only two severe reactions reported were reversible with treatment. In (90.9%) of the patients, more than one adverse event occurred. Conclusions: CIMAvax EGF was safe in the treated patients. Despite presenting adverse events in most of the patients, these were mild and transient.