title: Phase I trial of preoperative intratumoral injection of immature dendritic cells and OK-432 for resectable pancreatic cancer patients.
abstract: OBJECTIVE
  To determine the feasibility, safety and histological change of preoperative endoscopic ultrasound-guided fine-needle injection (PEU-FNI) of immature DCs (iDCs) with OK-432 in pancreatic cancer patients.
  
  
  METHODS
  Nine patients enrolled in the trial (DC group) and were compared with 15 patients operated on without iDC injection (non-DC group). Adverse events of PEU-FNI and postoperative complications were evaluated according to CTC-AE ver.3.0 and the Clavien-Dindo classification/ISGPF definition, respectively. Histological changes within the tumor and lymph nodes were evaluated by immunohistochemical examination of infiltrating inflammatory cells (CD4+, CD8+, Foxp3+ and CD83+).
  
  
  RESULTS
  There were no severe toxicities following PEU-FNI, except for one transient grade 3 fever, and there were no significant differences in the incidence of postoperative complications between the two groups. Colliquative necrosis and diffusely scattered TUNEL-positive cells were observed at the injection sites. CD83+ cells significantly accumulated in the regional lymph nodes of the DC group as well as Foxp3+ cells in the regional and distant lymph nodes. The two DC group patients, one of which was stage IV with distant lymph node metastasis, survived more than 5 years without requiring adjuvant theraphy.
  
  
  CONCLUSIONS
  PEU-FNI was feasible and safe, and further study needs to confirm and enhance antitumor responses.
authors: Department of Regenerative Surgery, Fukushima Medical University, 1 Hikariga-oka, Fukushima 960-1295, Japan.
authors: Hisahito
authors: H
authors: Endo
authors: Takuro
authors: T
authors: Saito
authors: Akira
authors: A
authors: Kenjo
authors: Mika
authors: M
authors: Hoshino
authors: Masanori
authors: M
authors: Terashima
authors: Tetsu
authors: T
authors: Sato
authors: Takayuki
authors: T
authors: Anazawa
authors: Takashi
authors: T
authors: Kimura
authors: Takao
authors: T
authors: Tsuchiya
authors: Atsushi
authors: A
authors: Irisawa
authors: Hiromasa
authors: H
authors: Ohira
authors: Takuto
authors: T
authors: Hikichi
authors: Tadayuki
authors: T
authors: Takagi
authors: Mitsukazu
authors: M
authors: Gotoh
mesh_terms: D000230:Adenocarcinoma / Q000276:immunology* / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D003713:Dendritic Cells / Q000276:immunology*; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D015552:Injections, Intralesional; D008198:Lymph Nodes / Q000473:pathology; D016246:Lymphocytes, Tumor-Infiltrating; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000276:immunology* / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D010844:Picibanil / Q000008:administration & dosage*; D057234:Preoperative Period
chemical_list: D000970:Antineoplastic Agents; D010844:Picibanil