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99mTc-利妥昔单抗用于乳腺癌患者前哨淋巴结定位的临床评估

Clinical Evaluation of 99mTc-Rituximab for Sentinel Lymph Node Mapping in Breast Cancer Patients.

作者信息

Li Nan, Wang Xuejuan, Lin Baohe, Zhu Hua, Liu Cheng, Xu Xiaobao, Zhang Yan, Zhai Shizhen, OuYang Tao, Li Jinfeng, Yang Zhi

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and.

出版信息

J Nucl Med. 2016 Aug;57(8):1214-20. doi: 10.2967/jnumed.115.160572. Epub 2016 Mar 16.

Abstract

UNLABELLED

The metastatic status of sentinel lymph nodes (SLNs) might be the most important prognostic factor in breast cancer. In this paper, we report to our knowledge the first study of (99m)Tc-rituximab as a radiotracer for imaging of SLNs using lymphoscintigraphy in both preoperative and intraoperative breast cancer patients.

METHODS

(99m)Tc-rituximab was designed as an SLN tracer targeting the CD20 antigen, which expresses extensively in LNs. A retrospective study was performed on 2,317 patients with primary breast cancer who underwent lymphoscintigraphy and sentinel lymph node biopsy (SLNB). Before imaging, all patients were administered a preoperative peritumoral injection of 37 MBq of (99m)Tc-rituximab.

RESULTS

(99m)Tc-rituximab was synthesized in both high radiolabeling yield and high radiochemical purity (>95%), with molecular integrity and immune activity well maintained. The initial study of 100 breast cancer patients showed that the success rate of SLN lymphoscintigraphy by injection of (99m)Tc-rituximab, as compared with SLNB, was 100%, and the sensitivity, specificity, accuracy, and false negative rate were 97.4%, 100%, 98.0%, and 2.60%, respectively. Of the following 2,217 patients studied, the success rate of lymphoscintigraphy and SLNB was 98.8% and 99.9%, and the average number of SLN was 1.78 (range, 1-10) and 2.85 (range, 1-15). Age was an independent predictor of the number of SLNs identified by lymphoscintigraphy and intraoperative handheld γ-probe (P < 0.05), and other factors-such as sex, imaging time, primary tumor site, histopathologic subtype, clinical T stage, and immunochemistry-were not (P > 0.05). However, the SLN metastatic rates were different in patients with different histopathologic subtype, clinical T stage, and immunochemistry (P < 0.05).

CONCLUSION

Here we report the first study of the new radiotracer (99m)Tc-rituximab for breast cancer lymphoscintigraphy. This tracer showed great feasibility, safety, and effectiveness for SLN mapping in breast cancer patients.

摘要

未标记

前哨淋巴结(SLN)的转移状态可能是乳腺癌最重要的预后因素。在本文中,据我们所知,我们报告了第一项关于(99m)锝-利妥昔单抗作为放射性示踪剂,用于术前和术中乳腺癌患者淋巴闪烁显像SLN成像的研究。

方法

(99m)锝-利妥昔单抗被设计为一种靶向CD20抗原的SLN示踪剂,CD20抗原在淋巴结中广泛表达。对2317例接受淋巴闪烁显像和前哨淋巴结活检(SLNB)的原发性乳腺癌患者进行了一项回顾性研究。在成像前,所有患者均在肿瘤周围进行术前注射37MBq的(99m)锝-利妥昔单抗。

结果

(99m)锝-利妥昔单抗的合成具有高放射性标记产率和高放射化学纯度(>95%),分子完整性和免疫活性得到良好维持。对100例乳腺癌患者的初步研究表明,与SLNB相比,注射(99m)锝-利妥昔单抗进行SLN淋巴闪烁显像的成功率为100%,敏感性、特异性、准确性和假阴性率分别为97.4%、100%、98.0%和2.60%。在随后研究的2217例患者中,淋巴闪烁显像和SLNB的成功率分别为98.8%和99.9%,SLN的平均数量分别为1.78(范围1 - 10)和2.85(范围1 - 15)。年龄是通过淋巴闪烁显像和术中手持式γ探测器确定的SLN数量的独立预测因素(P < 0.05),而其他因素,如性别、成像时间、原发肿瘤部位、组织病理学亚型、临床T分期和免疫化学等则不是(P > 0.05)。然而,不同组织病理学亚型、临床T分期和免疫化学的患者SLN转移率不同(P < 0.05)。

结论

在此我们报告了第一项关于新型放射性示踪剂(99m)锝-利妥昔单抗用于乳腺癌淋巴闪烁显像的研究。该示踪剂在乳腺癌患者SLN定位中显示出极大的可行性、安全性和有效性。

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