title: Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen.
abstract: Twenty-seven subjects with squamous cell cancer of the head and neck received the neoadjuvant IRX-2 immunotherapy regimen prior to surgery in a Phase 2 trial. Pretreatment tumor biopsies were compared with the primary tumor surgical specimens for lymphocyte infiltration, necrosis and fibrosis, using hematoxylin and eosin stain and immunohistochemistry in 25 subjects. Sections were examined by three pathologists. Relative to pretreatment biopsies, increases in lymphocyte infiltration (LI) were seen using H and E or immunohistochemistry. CD3+ CD4+ T cells and CD20+ B cells were primarily found in the peritumoral stroma and CD3+ CD8+ T cells and CD68+ macrophages were mainly intratumoral. LI in the surgical specimens were associated with reductions in the primary tumor size. Improved survival at 5 years was correlated with high overall LI in the tumor specimens. Neoadjuvant IRX-2 immunotherapy regimen may restore immune responsiveness presumably by mobilizing tumor infiltrating effector lymphocytes and macrophages into the tumor.
authors: IRX Therapeutics Inc., New York, NY, USA.
authors: Neil L
authors: NL
authors: Berinstein
authors: Gregory T
authors: GT
authors: Wolf
authors: Paul H
authors: PH
authors: Naylor
authors: Lorraine
authors: L
authors: Baltzer
authors: James E
authors: JE
authors: Egan
authors: Harvey J
authors: HJ
authors: Brandwein
authors: Theresa L
authors: TL
authors: Whiteside
authors: Lynn C
authors: LC
authors: Goldstein
authors: Adel
authors: A
authors: El-Naggar
authors: Cecile
authors: C
authors: Badoual
authors: Wolf-Herve
authors: WH
authors: Fridman
authors: J Michael
authors: JM
authors: White
authors: John W
authors: JW
authors: Hadden
mesh_terms: D000328:Adult; D000368:Aged; D016207:Cytokines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D006258:Head and Neck Neoplasms / Q000276:immunology* / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D016246:Lymphocytes, Tumor-Infiltrating / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D012044:Regression Analysis; D016019:Survival Analysis
chemical_list: D016207:Cytokines; C114857:IRX 2