复发性脑胶质瘤的免疫导向放疗临床试验研究

目的 探讨人鼠嵌合型TNT抗体标载131I(131I-chTNT)在治疗复发性恶性脑胶质瘤的免疫导向放疗(immune targeted-brachytherapy,ITB)疗效和毒副作用.方法 总结2001年9月-2003年3月完成131I-chTNT的Ⅱ期和Ⅲ期临床试验的71例复发性恶性脑胶质瘤患者治疗的临床资料.比较鞘内给药(第1组)、经股动脉-颈内动脉、椎-基底动脉插管的介入给药(第2组)、术后瘤内局部给药(第3组)3种不同给药方法的特点与疗效的关系.结果 临床疗效依据WHO判定实体瘤的疗效评定,第1组8例患者中CR 0例(0.0％),PR 1例(12.5％),SD 2例(25.0％),PD 5例(62.5％).第2组7例中CR 1例(14.3％),PR 2例(28.6％),SD 2例(28.6％),PD 2例(28.6％).第3组56例中CR21例(37.5％),PR 24例(42.8％),SD 7例(12.5％),PD 4例(7.1％).2010年在临床试验结束后7年的随访中第3组仍有3例(5.3％)存活,且肿瘤影像学治愈.结论 鞘内给药,核素不能进入瘤区杀伤瘤细胞；脑动脉介入给药是瘤区血管床内近距离放疗；瘤内局部给药临床疗效好、毒副作用轻微.

Immuno-targeted brachytherapy for recurrent cerebral glioma

Objective To study the clinical outcome and adverse effects of immuno-targeted brachytherapy（ITB） with ^131I-chTNT on recurrent malignant cerebral glioma. Methods Clinical data about 71 patients with recurrent malignant cerebral glioma who received ITB with 131I-chTNT in a phase-Ⅱ and Ⅲ clinical trial from September 2001 to March 2003 were summarized. Correlation between different drug administration methods, including intrathecal injection （group 1）, transfemoral artery - internal carotid artery delivery through ICA/（group 2）, postoperative intra-tumor local delivery （group 3） and the clinical outcome of glioma was observed. Results The clinical outcomes of glioma patients were assessed according to the WHO solid tumor scales. CR, PR, SD and PD were found in 0（0%）, 1（12.5%）, 2（25.0%） and 5（62.5%） out of the 8 patients in group 1, in 1（14.3%）, 2（28.6%）, 2（28.6%） and 2（28.6%） out of the 7 patients in group 2, in 21（37.5%）, 24（42.8%）, 7（12.5%） and 4（7.1%） out of the 53 patients in group 3. The patients（5.3%） in group 3 were still alive during the 7-year follow-up period after the trial and MRI showed that they were completely cured. Conclusion If the effect and adverse effect of the 3 drug delivery methods are compared, intrathecal injection of drugs is found in fact to be a subarchnoid brachytherapy during which radioactive agents cannot enter the tumor, trans-cerebral drug delivery is a brachytherapy through tumor blood vessel bed, and intra-tumor brachytherapy is a zero-distance radiotherapy which can achieve a good outcome of glioma with mild toxic and adverse effects, and is thus used as a standard clinical therapy for glioma.