【翻译摘要】《Radiology 》CT引导经皮注射基因治疗对转移肾细胞癌安全
Radiology. 2004 May;231(2):359-64.
Suh RD, Goldin JG, Wallace AB, Sheehan RE, Heinze SB, Gitlitz BJ, Figlin RA.
Department of Radiological Sciences, UCLA Medical Center, 10833 Le Conte Ave, B2-168 CHS, Los Angeles, CA 90095-1721.
PURPOSE: To assess the technical feasibility and safety of weekly outpatient percutaneous computed tomographic (CT)-guided intratumoral injections of interleukin-2 (IL-2) plasmid DNA in a wide variety of superficial and deep tumor sites. MATERIALS AND METHODS: Twenty-nine patients with metastatic renal cell carcinoma and a total of 30 lesions measuring 1.0 cm(2) or greater in accessible thoracic (n = 15) or abdominal (n = 15) locations underwent up to three cycles of six weekly intratumoral IL-2 plasmid DNA injections. CT was used to guide needle placement and injection. After injection cycle 1, patients whose tumors demonstrated stable (</=25% increase and </=50% decrease in product of lesion diameters) or decreased size (>50% decrease in product of lesion diameters) advanced to injection cycle 2. Patients whose lesions decreased in size by more than 50% over the course of injection cycle 2 were eligible to begin injection cycle 3. An acceptable safety and technical feasibility profile for this technique was deemed to be (a) a safety and feasibility profile similar to that of single-needle biopsy and (b) an absence of serious adverse events (as defined in Title 21 of the Code of Federal Regulations) and/or unacceptable toxicities (as graded according to the National Cancer Institute Common Toxicity Criteria). RESULTS: A total of 284 intratumoral injections were performed, with a mean of 9.8 injections (range, 6-18 injections) received by each patient. Technical success (needle placement and injection of gene therapy agent) was achieved in all cases. Complications were experienced after 42 (14.8%) of the 284 injections. The most common complication was pneumothorax (at 32 [28.6%] of 112 intrathoracic injections), for which only one patient required catheter drainage. Complications occurred randomly throughout injection cycles and did not appear to increase as patients received more injections (P =.532). No patient experienced serious adverse events or unacceptable toxicities. CONCLUSION: Percutaneous CT-guided intratumoral immunotherapy injections are technically feasible and can be safely performed.
CT引导经皮注射基因治疗对转移肾细胞癌安全
最近的一项新研究表明对转移的肾细胞癌病人,可以通过CT引导的经皮瘤内注射安全地进行基因治疗。
美国加州大学洛杉矶医疗中心的Robert D. Suh通过注射白细胞介素-2质体DNA治疗了29名门诊病人(每周6次,3个疗程),所治深、浅病变共30处,其中胸内转移15处,腹内15处。治疗第一疗程后,肿瘤保持稳定或缩小至少50%的病人进入第二疗程治疗,肿瘤再缩小至少50%的病人继续第三疗程治疗。每次治疗针头经由CT引导,经皮注射,且每次操作均成功。
研究人员在《Radiology 2004;231:359-364》上报告,共注射了284次,平均每人注射9.8次。注射24小时后出现并发症,最常见的是气胸,但只有1人需要导管引流。“没有严重的副反应或无法接受的毒性作用”,研究者说。“我们已证实,多处肿瘤都可进行多次CT引导的经皮免疫制剂瘤内注射,操作成功性极高,而并发症危险很小”,研究者们总结。目前,确定治疗反应的II期试验正在进行之中。
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