Abstract
Cervical uterine cancer represents the fourth most common malignant neoplasm worldwide in the female sex in terms of incidence, principally from epithelial origen. The high expression of EGFR in this tumor leads to the search for therapeutic alternatives. An Expanded Access Clinical Program was carried out in parallel groups, randomized, multicenter and prospective study, to evaluate the survival of patients with advanced cervical carcinoma, without therapeutic alternative, who would be treated with the therapeutic vaccine CIMAvax-EGF®, the humanized mAb nimotuzumab or the combination of both products, which targeted EGF and EGFR respectively. The patients were included between 2008 and 2010 with a more than five years follow-up. The results show that the serious adverse events related to the experimental treatments were 0.9%; 1.1% and 2.6% and a median ITT survival of 9.1, 23.5, and 16.3 months for CIMAvax-EGF®, nimotuzumab and the combination of both, respectively. Thus fulfilling the hypothesis of safety and efficacy proposed in the investigation was achieved. The three therapeutic regimens achieved overall survival rates greater than 35% at 60 months, encouraging results for advanced uterine cervical cancer. A phase III clinical trial is proposed to consolidate these results in a greater number of patients with nimotuzumab as study drug.
Highlights
Cervical uterine cancer represents the fourth malignant neoplasm with the highest incidence in the world in women with 569,847 in 2018
The results show that the serious adverse events related to the experimental treatments were 0.9%; 1.1% and 2.6% and a median ITT survival of 9.1, 23.5, and 16.3 months for CIMAvax-EGF®, nimotuzumab and the combination of both, respectively
The humanized monoclonal antibodies (mAbs) nimotuzumab directed against Epidermal Growth Factor Receptor (EGFR) has been demonstrated a therapeutic efficacy, with increased survival in patients with persistent, recurrent or advanced-stage cervical cancer used as monotherapy [5] [6]
Summary
Cervical uterine cancer represents the fourth malignant neoplasm with the highest incidence in the world in women with 569,847 in 2018 It is reported as the fourth cause of death from cancer in this sex, being Latin America and the Caribbean a health problem public, with a mortality rate of 7.1/100,000 inhabitants, which is the third in the world [1]. These neoplasms predominantly had epithelial origin, with overexpressing the Epidermal Growth Factor Receptor (EGFR) in a high percentage [2] [3] [4]. The CIMAvax EGE vaccine has shown therapeutic efficacy in patients with non-small cell lung tumors (NSCLC) [7], due to its capacity to develop anti EGF antibodies able to reduce circulating EGF concentrations by increasing the antibody titer in treated patients
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