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转移性 NSCLC 中重复 CT 引导下经胸瘤内注射基因修饰细胞免疫治疗的技术可行性与安全性

英文原题:Technical Feasibility and Safety of Repeated Computed Tomography-Guided Transthoracic Intratumoral Injection of Gene-Modified Cellular Immunotherapy in Metastatic NSCLC.

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Technical Feasibility and Safety of Repeated Computed Tomography-Guided Transthoracic Intratumoral Injection of Gene-Modified Cellular Immunotherapy in Metastatic NSCLC.

PubMed 2021/10/14(内容时间) JTO Clin Res Rep Q2 · IF 3.6(JCR 2025)

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研究概要

重复经皮、经胸 CT 引导下活检及瘤内基因修饰细胞免疫治疗注射治疗肺癌在技术上可行、安全且可重复。无操作相关严重(定义为≥3 级)不良事件。

研究思路结论见上方概要

评估在转移性NSCLC中重复进行经皮计算机断层扫描(CT)引导的经胸活检及瘤内注射基因修饰树突状细胞的技术可行性和安全性。

共15例患者,15个大于1.0 cm的NSCLC病灶,接受了两个周期的瘤内活检和CCL21树突状细胞注射,间隔7天。所有针头置入和注射均在CT引导下完成。首次操作后约4周进行临床和影像学随访。安全性和可行性判定标准为:(1)安全性和可行性与单针活检相似,(2)无严重不良事件,严重不良事件定义为根据美国国家癌症研究所不良事件通用术语标准5.0版,等级大于或等于3级。

共进行了30次经皮经胸肺内肿瘤活检和注射,每位患者接受两个周期(第0天和第7天)(311次活检和96次瘤内注射)。所有经皮病例在活检和注射CCL21树突状细胞的针头放置方面均取得技术成功。仅观察到轻微并发症(级别<3),包括气胸(n = 10,33%)和少量活检后出血(n = 2,7%)。气胸为中度(n = 1)或微量(n = 9),中度气胸经手动抽吸后缓解,无需置入胸管。无患者需要置入胸管。未发现与活检或树突状细胞注射相关的其他并发症或严重不良事件。所有患者在恢复室观察最长4小时后情况稳定,并于当天出院回家。4周时的影像学或临床随访中未观察到与操作相关的并发症。

展开英文摘要原文

A total of 15 patients with 15 NSCLC lesions measuring greater than 1.0 cm underwent two cycles of intratumoral biopsies and CCL21 dendritic cell injections separated by 7 days. All needle placements and injections were done under CT guidance. Clinical and imaging follow-up was done approximately 4 weeks after the first procedure. Safety and feasibility were determined as: (1) safety and feasibility similar to that of single-needle biopsy, and (2) an absence of serious adverse events defined as grade greater than or equal to three according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

A total of 30 percutaneous, transthoracic intratumoral biopsies and injections into the lung cancer were performed, two cycles (at d 0 and 7) received by each patient (311 biopsies and 96 intratumoral injections). All percutaneous cases achieved technical success with respect to needle placement for both biopsy and injection of CCL21 dendritic cells. Only minor complications were observed (grade <3), including pneumothorax (n = 10, 33%) and small postbiopsy hemorrhage (n = 2, 7%). Pneumothorax was moderate (n = 1) or trace (n = 9), with resolution of the moderate pneumothorax after manual aspiration without chest tube placement. No patient required chest tube placement. No other complications or serious adverse effects related to the biopsy or dendritic cell injection were noted. All patients were in stable condition after up to 4 hours in the recovery unit and were discharged home on the same day. No procedure-related complications were observed on imaging or clinical follow-up at 4 weeks.

Repeated percutaneous, transthoracic CT-guided biopsies and intratumoral gene-modified cell-based immunotherapy injections into lung cancers are technically feasible, safe, and reproducible. There were no procedure-related serious (defined as grade ≥3) adverse events.

论文信息

作者
Shahrouki P、Lee JM、Barclay J、Khan SN、Genshaft S、Abtin F、Dubinett SM、Lisberg A
单位
Department of Radiological Sciences, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.United States
期刊
JTO clinical and research reports2021 Nov
原文标识
PubMed 34806054 · DOI 10.1016/j.jtocrr.2021.100242