PMID- 22024351 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20111123 LR - 20211020 IS - 1476-8518 (Electronic) IS - 1476-8518 (Linking) VI - 9 DP - 2011 Oct 24 TI - 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. PG - 7 LID - 10.1186/1476-8518-9-7 [doi] AB - 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 2.4 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. FAU - Rodriguez, Pedro C AU - Rodriguez PC AD - Center of Molecular Immunology, PO Box: 16040, Havana 11600, Cuba. camilo@cim.sld.cu. FAU - Neninger, Elia AU - Neninger E FAU - Garcia, Beatriz AU - Garcia B FAU - Popa, Xitlally AU - Popa X FAU - Viada, Carmen AU - Viada C FAU - Luaces, Patricia AU - Luaces P FAU - Gonzalez, Gisela AU - Gonzalez G FAU - Lage, Agustin AU - Lage A FAU - Montero, Enrique AU - Montero E FAU - Crombet, Tania AU - Crombet T LA - eng PT - Journal Article DEP - 20111024 PL - England TA - J Immune Based Ther Vaccines JT - Journal of immune based therapies and vaccines JID - 101152206 PMC - PMC3215653 EDAT- 2011/10/26 06:00 MHDA- 2011/10/26 06:01 PMCR- 2011/10/24 CRDT- 2011/10/26 06:00 PHST- 2011/04/28 00:00 [received] PHST- 2011/10/24 00:00 [accepted] PHST- 2011/10/26 06:00 [entrez] PHST- 2011/10/26 06:00 [pubmed] PHST- 2011/10/26 06:01 [medline] PHST- 2011/10/24 00:00 [pmc-release] AID - 1476-8518-9-7 [pii] AID - 10.1186/1476-8518-9-7 [doi] PST - epublish SO - J Immune Based Ther Vaccines. 2011 Oct 24;9:7. doi: 10.1186/1476-8518-9-7.