Background:

Non-small cell lung cancer is the cancer of epithelial origin that causes most of deaths; so the study of new therapies is a research priority in Cuba; thus, multicenter studies are carried out which evaluate, among other aspects, the safety profile of nimotuzumab and racotumomab, monoclonal antibodies of Cuban origin in the treatment of this disease.

Objective:

To evaluate the safety profile of nimotuzumab and racotumomab in patients with advanced non-small cell lung cancer after the first-line of oncospecific treatment.

Methodology:

A multicenter, prospective, longitudinal study was designed in 32 adult patients with advanced non-small cell lung cancer after the first-line of oncospecific treatment in Sancti Spíritus province from June 2014 to June 2015.

Results:

The six patients who received nimotuzumab and the twenty-six patients who received racotumomab, in tumor stage IIIB or IV, 75 % participated in the study with good clinical conditions. The 66% of them did not present adverse effects, among which there were, pain at the location of injection, thoracic pain and fever, all of mild or moderate intensity. No significant differences were found between the proportions of mild adverse events in both groups of subjects. No severe adverse events were reported. All events were classified as non-serious, non-very serious and 98.33 % of them recovered without medical help.

Conclusions:

The results suggest that the products used are safe, expressed in the low frequency of occurrence of adverse events, the generality of them mild non-very serious / non-serious, without no sequel in patients.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )