Details

Autor(en) / Beteiligte

• 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

Titel

Phase I trial of preoperative intratumoral injection of immature dendritic cells and OK-432 for resectable pancreatic cancer patients

Ist Teil von

• Journal of hepato-biliary-pancreatic sciences, 2012-07, Vol.19 (4), p.465-475

Ort / Verlag

Japan: Blackwell Publishing Ltd

Erscheinungsjahr

2012

Quelle

Access via Wiley Online Library

Beschreibungen/Notizen

• 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.