新型ct引导的188-铼近距离治疗局部原发性和继发性肺恶性肿瘤装置。

H. Belhadj-Tahar, Jindde Chen, P. Song, Jun Zhao, M. Quan, Caixin Li, Xingjian Gu, Guanghua Yang, Yong Gao
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引用次数: 3

摘要

背景:立体定向近距离治疗广泛的局部肿瘤是一种非常有效的治疗选择,对医学功能受损的患者没有明显的并发症。在这种背景下,我们最近从Poly-L-Lysins树状大分子中开发了一种新的潜在抗癌剂,作为递送纳米系统,负载可扩散咪唑探针与188-铼络合,用于靶向对常规癌症治疗具有抗性的特定缺氧肿瘤。该研究的目的是评估由[188Re]铼配体衍生的抗癌药物作为放射性配体负载第五代聚l -赖氨酸树突状物在不可切除的肺部恶性肿瘤患者中的安全性和治疗效果。方法:实验药剂“188Re- imdendrim”由第5代聚l-赖氨酸树状大分子(20 nM)与GMP级硝基咪唑-甲基-1,2,3-三唑-甲基-二-(2-pycolyl)胺混合而成,用[188Re]-铼标记。本研究经上海东方医院伦理委员会批准。5例患者在ct引导下将“188Re-ImDendrim”直接植入肺肿瘤,活性水平为162 MBq/cc肿瘤(范围2 ~ 7 cm;平均直径4厘米)。对于体积较大的肿瘤(bbb65 cc),剂量间隔2周分次注射(肿瘤115cc: 2次给药,肿瘤180cc: 3次给药)。给药后H0.5、h4、H24、H36、H72行SPECT对照。通过PET/CT标准化摄取值(suv)评估治疗反应。结果:所有患者均在局麻下成功进行立体定向给药。放射性产物在肿瘤体积内均匀扩散,给药后72小时仍存在,注射部位外无明显扩散。5例患者中有1例报告离散性移行性咯血为不良事件。所有靶向肿瘤在12周时均有应答,其中2例完全应答。结论:这种新型的188-铼- imendendrim近距离治疗装置经皮单次和反复应用于肺癌是安全且耐受性良好的。关于治疗反应的初步数据是有希望的。临床试验信息:EC。D (bg) 016.03.1。
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Novel CT-guided 188-rhenium brachytherapy device for local primary and secondary lung malignancies.
96 Background: Stereotactic brachytherapy for extensive local tumors offers a very effective treatment option locally without significant complications in medically impaired patients. In this context, we have recently developed a new potential anticancer agent from Poly-L-Lysins dendrimer as a delivery nano system loaded with diffusible Imidazolic probes complexed with 188-Rhenium for targeting in particular hypoxic tumors resistant to conventional cancer treatments. The aim of the study is assessment the safety profile and therapeutic efficacy of anticancer agent derived from [188Re]rhenium-ligand as radioactive ligand loaded 5th generation poly-L-lysine dendrimer in patients with unresectable Lung Malignancies. Methods: The experiment agent “ 188Re-ImDendrim” is consisting of 5th generation poly-L-lysine dendrimer (20 nM) mixed with nitro-imidazole-methyl-1,2,3-triazol-methyl-di-(2-pycolyl) amine at GMP grade and labelled with [188Re]-rhenium. The study was approved by Shanghai East Hospital ethics committee. 5 patients received “188Re-ImDendrim” directly into lung tumors under CT-guidance, at an activity level of 162 MBq/cc of tumor (range 2 to 7 cm; mean diameter, 4 cm) . For voluminous tumors ( > 65 cc) the dose is given in divided injection spaced 2 weeks apart (Tumor of 115cc: 2 administrations, Tumor of 180 cc: 3 administrations). At H0.5, H 4, H24, H36 , H72 post-administration, the patient get a SPECT control. The response to treatment is evaluated thanks to PET/CT Standardized Uptake Values (SUVs). Results: Stereotactic administrations of “188-Rhenium-ImDendrim” were successfully carried out in all patients under local anesthesia. The radioactive product diffuses homogeneously in the tumor volume and remains 72 hours post-administration with no significant diffusion out site of injection. The One of the 5 patients reported discrete transitive hemoptysis as adverse events. All targeted tumors were responding at 12 weeks, with two complete responses. Conclusions: Percutaneous single and iterative administrations of this novel 188-Rhenium-Imdendrim brachytherapy device into lung cancers are safe and well tolerated. The initial data on therapeutic response are promising. Clinical trial information: EC.D (BG) 016.03.1.
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期刊介绍: The Journal of Global Oncology (JGO) is an online only, open access journal focused on cancer care, research and care delivery issues unique to countries and settings with limited healthcare resources. JGO aims to provide a home for high-quality literature that fulfills a growing need for content describing the array of challenges health care professionals in resource-constrained settings face. Article types include original reports, review articles, commentaries, correspondence/replies, special articles and editorials.
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