Department of Regenerative Surgery, Fukushima Medical University, 1 Hikariga-oka, Fukushima 960-1295, Japan.
J Hepatobiliary Pancreat Sci. 2012 Jul;19(4):465-75. doi: 10.1007/s00534-011-0457-7.
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.
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+).
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.
PEU-FNI was feasible and safe, and further study needs to confirm and enhance antitumor responses.
确定术前内镜超声引导下 OK-432 不成熟树突状细胞（iDCs）注射（PEU-FNI）治疗胰腺癌患者的可行性、安全性和组织学变化。
本试验纳入 9 例患者（DC 组），并与未行 iDC 注射的 15 例手术患者（非 DC 组）进行比较。根据 CTC-AE ver.3.0 和 Clavien-Dindo 分类/ISGPF 定义评估 PEU-FNI 的不良事件和术后并发症。通过浸润性炎症细胞（CD4+、CD8+、Foxp3+和 CD83+）的免疫组织化学检查评估肿瘤和淋巴结内的组织学变化。
除 1 例短暂的 3 级发热外，PEU-FNI 无严重毒性，两组术后并发症发生率无显著差异。注射部位可见液化性坏死和弥漫性 TUNEL 阳性细胞。DC 组局部淋巴结中 CD83+细胞明显聚集，局部和远处淋巴结中 Foxp3+细胞聚集。2 例 DC 组患者中，1 例为伴有远处淋巴结转移的 IV 期患者，无需辅助治疗，已存活超过 5 年。
PEU-FNI 是可行且安全的，需要进一步研究以确认和增强抗肿瘤反应。
