一项（99m）Tc-替拉诺肽在黑色素瘤和乳腺癌前哨淋巴结检测中的 2 期研究。
A phase 2 study of (99m)Tc-tilmanocept in the detection of sentinel lymph nodes in melanoma and breast cancer.
机构信息
California Pacific Medical Center and Sutter Pacific Medical Foundation and Research Institute, University of California, San Francisco, CA, USA.
出版信息
Ann Surg Oncol. 2011 Apr;18(4):961-9. doi: 10.1245/s10434-010-1524-z. Epub 2011 Feb 18.
BACKGROUND
Several (99m)Tc-labeled agents that are not approved by the U.S. Food and Drug Administration are used for lymphatic mapping. A new low-molecular-weight mannose receptor-based, reticuloendothelial cell-directed, (99m)Tc-labeled lymphatic imaging agent, (99m)Tc-tilmanocept, was used for lymphatic mapping of sentinel lymph nodes (SLNs) from patients with primary breast cancer or melanoma malignancies. This novel molecular species provides the basis for potentially enhanced SLN mapping reliability.
METHODS
In a prospectively planned, open-label phase 2 clinical study, (99m)Tc-tilmanocept was injected into breast cancer and cutaneous melanoma patients before intraoperative lymphatic mapping. Injection technique, preoperative lymphoscintigraphy (LS), and intraoperative lymphatic mapping with a handheld gamma detection probe were performed by investigators per standard practice.
RESULTS
Seventy-eight patients underwent (99m)Tc-tilmanocept injection and were evaluated (47 melanoma, 31 breast cancer). For those whom LS was performed (55 patients, 70.5%), a (99m)Tc-tilmanocept hot spot was identified in 94.5% of LS patients before surgery. Intraoperatively, (99m)Tc-tilmanocept identified at least one regional SLN in 75 (96.2%) of 78 patients: 46 (97.9%) of 47 in melanoma and 29 (93.5%) of 31 in breast cancer cases. Tissue specificity of (99m)Tc-tilmanocept for lymph nodes was 100%, displaying 95.1% mapping sensitivity by localizing in 173 of 182 nodes removed during surgery. The overall proportion of (99m)Tc-tilmanocept-identified nodes that contained metastatic disease was 13.7%. Five procedure-related serious adverse events occurred, none related to (99m)Tc-tilmanocept.
CONCLUSIONS
Our results demonstrate the safety and efficacy of (99m)Tc-tilmanocept for use in intraoperative lymphatic mapping. The high intraoperative localization and lymph node specificity of (99m)Tc-tilmanocept and the identification of metastatic disease within the nodes suggest SLNs are effectively identified by this novel mannose receptor-targeted molecule.
背景
有几种未经美国食品和药物管理局批准的（99m）Tc 标记的药物被用于淋巴作图。一种新型的低分子量甘露糖受体为基础的、网状内皮细胞定向的（99m）Tc 标记的淋巴管成像剂，（99m）Tc-tilmanocept，被用于原发性乳腺癌或黑色素瘤患者的前哨淋巴结（SLN）的淋巴作图。这种新型的分子为潜在的增强 SLN 作图可靠性提供了基础。
方法
在一项前瞻性计划的、开放标签的 2 期临床研究中，（99m）Tc-tilmanocept 在乳腺癌和皮肤黑色素瘤患者的术中淋巴作图前注射。注射技术、术前淋巴闪烁显像（LS）和手持伽马探测探头的术中淋巴作图由研究者按照标准实践进行。
结果
78 名患者接受了（99m）Tc-tilmanocept 注射并进行了评估（47 例黑色素瘤，31 例乳腺癌）。对于进行 LS 的 55 名患者（70.5%），术前 94.5%的 LS 患者中可以识别出（99m）Tc-tilmanocept 热点。在 78 名患者中，75 名（96.2%）患者的（99m）Tc-tilmanocept 术中至少可以识别一个区域的 SLN：46 名（97.9%）黑色素瘤患者和 29 名（93.5%）乳腺癌患者。（99m）Tc-tilmanocept 对淋巴结的组织特异性为 100%，通过在手术中切除的 182 个淋巴结中的 173 个定位，定位灵敏度为 95.1%。含有转移性疾病的（99m）Tc-tilmanocept 识别的淋巴结的总体比例为 13.7%。5 例与操作相关的严重不良事件发生，无 1 例与（99m）Tc-tilmanocept 有关。
结论
我们的结果证明了（99m）Tc-tilmanocept 用于术中淋巴作图的安全性和有效性。（99m）Tc-tilmanocept 在术中的高定位和淋巴结特异性以及在淋巴结内识别出转移性疾病表明，这种新型的甘露糖受体靶向分子可以有效地识别 SLN。
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