与5-aminolevulinic酸Fluorescence-guided手术切除的恶性神经胶质瘤:随机对照多中心三期临床试验。
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葡萄汁W Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ
与5-aminolevulinic酸Fluorescence-guided手术切除的恶性神经胶质瘤:随机对照多中心三期临床试验。
柳叶刀杂志。2006;7 (5):392 - 401。
- PubMed ID
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16648043 (在PubMed]
- 文摘
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背景:5-Aminolevulinic酸荧光前体药物,导致细胞内积累的荧光卟啉在恶性gliomas-a为术中识别和发现正在调查这些肿瘤的切除。我们的目的是评估的影响与5-aminolevulinic酸fluorescence-guided切除手术表达,无进展生存,整体存活率和发病率。方法:23 - 73岁的322例疑似恶性神经胶质瘤适合充当的完整切除肿瘤被随机分配到20毫克/公斤体重5-aminolevulinic酸fluorescence-guided切除(n = 161)或传统显微外科与白光(n = 161)。主要的端点的患者数量没有充当肿瘤早期MRI(即获得后72小时内手术)和6个月无进展生存评估MRI。二次端点的残余肿瘤术后MRI,整体生存,神经赤字,和毒性作用。我们报告一个临时分析的结果与270例全面分析人口(139分配5-aminolevulinic酸,131分配白光),不能排除患者组织学和放射学结果评估中心评审人蒙面治疗分配;临时分析导致终止研究定义的协议。主要和次要端点意图治疗分析的全面分析。这项研究是在http://www.clinicaltrials.gov注册NCT00241670。结果:平均随访35.4个月(95% CI 1.0 - -56.7)。 Contrast-enhancing tumour was resected completely in 90 (65%) of 139 patients assigned 5-aminolevulinic acid compared with 47 (36%) of 131 assigned white light (difference between groups 29% [95% CI 17-40], p<0.0001). Patients allocated 5-aminolevulinic acid had higher 6-month progression free survival than did those allocated white light (41.0% [32.8-49.2] vs 21.1% [14.0-28.2]; difference between groups 19.9% [9.1-30.7], p=0.0003, Z test). Groups did not differ in the frequency of severe adverse events or adverse events in any organ system class reported within 7 days after surgery. INTERPRETATION: Tumour fluorescence derived from 5-aminolevulinic acid enables more complete resections of contrast-enhancing tumour, leading to improved progression-free survival in patients with malignant glioma.
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