TITLE:
Specific Immunotherapy in Advanced Cervical-Uterine Cancer Using Humanized Monoclonal Antibody Nimotuzumab and CIMAvax-EGF® Therapeutic Vaccine
AUTHORS:
Raiza Ruiz-Lorente, Sayly Alfonso, Eduardo Santiesteban, Yamilka Sánchez, Kirenia Camacho, Erasmo Mendoza, Carmen Elena Viada, Ramón Ortiz, Ihosvannys Carreño, Mayelin Troche, Meylan Cepeda, Ana Rosa Vals, Leticia Cabrera, Annia Gorte, Delmis Batista, Milagros Domenech, Yanela Santiesteban, Yuliannis Santiesteban, Daymys Estevez, Jessica García-Viamontes, Conrado Ramos Mico, Mayra Ramos-Suzarte
KEYWORDS:
CIMAvax-EGF®, Nimotuzumab, Survival, Safety, Advanced Cervical Cancer
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.12 No.3,
March
25,
2021
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.