Premium
Phase I trial of preoperative intratumoral injection of immature dendritic cells and OK‐432 for resectable pancreatic cancer patients
Author(s) -
Endo Hisahito,
Saito Takuro,
Kenjo Akira,
Hoshino Mika,
Terashima Masanori,
Sato Tetsu,
Anazawa Takayuki,
Kimura Takashi,
Tsuchiya Takao,
Irisawa Atsushi,
Ohira Hiromasa,
Hikichi Takuto,
Takagi Tadayuki,
Gotoh Mitsukazu
Publication year - 2012
Publication title -
journal of hepato‐biliary‐pancreatic sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.63
H-Index - 60
eISSN - 1868-6982
pISSN - 1868-6974
DOI - 10.1007/s00534-011-0457-7
Purpose 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. Conclusion PEU‐FNI was feasible and safe, and further study needs to confirm and enhance antitumor responses.