Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients. | Rodriguez et al. Journal of Immune Based Therapies and Vaccines 2011 9 7 http content 9 1 7 JOURNAL OF IMMUNE BASED THERAPIES AND VACCINES ORIGINAL RESEARCH Open Access Safety immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor EGF based cancer vaccine in advanced non small cell lung cancer NSCLC patients 1 2 1 1 1 1 Pedro C Rodriguez Elia Neninger Beatriz García Xitlally Popa Carmen Viada Patricia Luaces Gisela Gonzalez1 Agustin Lage1 Enrique Montero1 2 and Tania Crombet1 Abstract The prognosis of patients with advanced non small cell lung NSCLC cancer remains dismal. Epidermal Growth Factor Receptor is over-expressed in many epithelial derived tumors and its role in the development and progression of NSCLC is widely documented. CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor EGF conjugated to a carrier protein P64K from Neisseria Meningitides. The vaccine is intended to induce antibodies against self EGF that would block EGF-EGFR interaction. CimaVax-EGF has been evaluated so far in more than 1000 advanced NSCLC patients as second line therapy. Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity safety and preliminary efficacy in stage IIIb IV NSCLC patients. In both clinical trials patients started vaccination 1 month after finishing first line chemotherapy. Vaccination at 4 sites with mg of EGF high dose was very safe. The most frequent adverse events were grade 1 or 2 injection site reactions fever headache and vomiting. Patients had a trend toward higher antibody response. The percent of very good responders significantly augmented and there was a faster decrease of circulating EGF. All vaccinated patients and those classified as good responders immunized with high dose at 4 sites had a large tendency to improved survival. Introduction In spite of an .
