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Volume 10

Journal of Archives of Medicine

Advanced Biotechnology & Annual Pediatrics 2018

November 28-29, 2018

Novel Trends and Advances in Biotechnology,

Cell & Stem Cell Research

Annual Congress on Pediatrics

World Congress on

November 28-29, 2018 Barcelona, Spain

Joint Event On

Safety and effectiveness of nimotuzumab in the treatment of advanced head and neck cancer

patients in open population

Aliz M Vega

Center of Molecular Immunology, Cuba

pidermal Growth Factor Receptor (EGFR) can be overexpressed in Head and Neck Cancer (HNC). Nimotuzumab is a

humanized monoclonal antibody (hMab) that binds to the EGFR. A phase IV study was conducted in advanced head and

neck newly diagnosed and recurrent cancer patients to evaluate safety and efficacy of nimotuzumab. Four therapeutic schemes

were evaluated: Nimotuzumab, nimotuzumab+Chemotherapy (Nimo+CT), nimotuzumab+Radiotherapy (Nimo+RT) and

nimotuzumab+Chemo+Radiotherapies (Nimo+CRT). Common toxicity criteria to evaluate Adverse Events (AEs) (version

3.0) was used to classify AEs; Kaplan-Meier curves were compared by the non-parametric Log-rank method and Cox regression

was applied for subgroup analyses. A total of 225 patients were included. Most AEs were classified as grade I, AEs related to the

product were reported in 36 patients. In this subgroup, most frequent events were anemia, leukopenia, neutropenia, anorexia,

nausea, vomiting, asthenia and fever. In the newly diagnosed subset (n=155), although no significant difference was shown in

the Intent-to-treat (ITT) analysis, there was a trend toward a benefit in favor of Nimo+CRT, not just related to Progression-

Free-Survival (PFS) (22.4 months; p=0.065), but also to Overall Survival (OS) (24.3 months; p=0.089), with higher survival

rates at 12 and 24 months for PFS (67.3% and 46.3%, respectively) and OS (70.1% and 50.3%, respectively), compared to the

other regimens. Administration of nimotuzumab was safe in the treatment of advanced HNC patients and well tolerated

despite the combination with CRT.

Arch Med 2018, Volume 10

DOI: 10.21767/1989-5216-C2-006