Vacina contra o cancro do pulmão
Clinical development and Perspectives of CImAvax EgF,
Cuban Vaccine for Non-small-cell Lung Cancer therapy
Review
Pedro C Rodríguez, MD, Gryssell Rodríguez, MS, Gisela González, PhD, Agustín Lage, MD, PhD
ABStRACt
Introduction CIMAvax EGF is a therapeutic anticancer vaccine developed entirely in Cuba and licensed in Cuba for use in adult patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). The vaccine is based on active immunotherapy by which an individual’s immune response is manipulated to release its own effector antibodies (Abs) against the epidermal growth factor (EGF).
Objective Review pre-clinical and clinical research conducted during development of CIMAvax EGF, primarily studies published by Cuban investigators in international peer-reviewed scientific journals.
Methods An automated search for “vaccine” and “EGF” was conducted in PubMed, resulting in 17 articles published by Cuban authors between January 1, 1994 and September 30, 2009. Main findings were described and discussed, along with unpublished preliminary findings of an initial ongoing phase III clinical trial.
Results Articles reviewed describe five phase I/II and one phase II clinical trials conducted in Cuba in 1995–2005. A non-controlled 1995–1996 study resulted in the earliest published scientific evidence of the feasibility of inducing an immune response against autologous EGF in patients with different advanced stage tumors. Subsequent controlled, randomized trials included patients with advanced stage (IIIB/IV) NSCLC. The 2nd
INtROduCtION
In Cuba, cancer is the second leading cause of death and the primary cause of years of potential life lost, making a significant impact on life expectancy at birth. Lung cancer is the malignant disease with highest incidence and also the leading cause of cancer mortality in the country. In 2005–2007, an average of 4234 new lung cancer cases and 4601 deaths from the disease