作者: Mark B. Faries , Eddy C. Hsueh , Xing Ye , Mary Hoban , Donald L. Morton
DOI: 10.1158/1078-0432.CCR-09-1540
关键词: Antigen 、 Immune system 、 Melanoma 、 Melanoma Vaccine 、 Surrogate endpoint 、 Immunology 、 Immunopotentiator 、 Medicine 、 Immunotherapy 、 Vaccination
摘要: Purpose: The availability of a variety immune response modifiers creates an opportunity for improved efficacy immunotherapy, but it also leads to uncertainty in how combine agents and assess those combinations. We sought the effect addition granulocyte/macrophage colony-stimulating factor (GM-CSF) vaccination with melanoma vaccine. Experimental Design: Ninety-seven patients resected (stage II-IV) were enrolled, stratified by stage, randomized receive cellular vaccine or without GM-CSF. primary endpoint was delayed-type hypersensitivity (DTH) cells. Antibody responses, peripheral leukocyte counts, survival examined. Results: GM-CSF arm showed enhanced antibody responses increase IgM titer against TA90 antigen increased complexes. This had diminished antimelanoma cell response. Peripheral blood profiles increases eosinophils basophils decreased monocytes arm. These changes accompanied early deaths trend toward worse Conclusion: data suggest that is not helpful as adjuvant this dose schedule raise concern may be harmful. Based on discordant findings clinical outcome, use such surrogate endpoints selecting treatments further evaluation must done great deal caution. (Clin Cancer Res 2009;15(22):7029–35)