Clinical Study Of Brachytherapy For Recurrent High Grade With ～(131)I-chTNT

Objective: To explore the clinical efficacity and safety of intratumoral radioimmunotherapy for recurrent high grade gliomas with iodine-131-labeled chimeric tumor necrosis treatment (¹³¹I-chTNT) via Ommaya reservoir.Methods: Twenty-nine postoperative patients with recurrent high grade gliomas World Health Organization(WHO) gradeâ…¢-â…£approved by pathology were randomly divided into ¹³¹I-chTNTgroup(13cases) and BCNU group(16cases). All the patients recieved reoperation and MRI examination 3 days later.During reoperation the Ommaya reservoir was placed in the resection cavity at the time of tumor debulking. Sacculus proprius was covered by scalp near incision. Seven days later,10%KI was took orally to block thyroid from uptaking of ¹³¹I .Fourteen days later , ¹³¹I-chTNT (30.1±5.8 mCi)was injected into the residual tumor via Ommaya reservoir. The treatment(28.5±5.5 mCi) was repeated on the postoperative day 28-30. SPECT body scan was applicated in the following day of administration.BCNU group was treated with BCNU(100mg/m2×3d) systemically fourteen days after operation. Administration with BCNU needs three Course of treatment of 6 weeks. All patients were followed up by out-patient clinic periodically on 3 and 6 months.Results: All patients received subtotal surgical treatment. In ¹³¹I-chTNT group, 11 cases (84.6 %) remained stable 3 months later, 2(15.4%) progress. 6 months later, ten cases(76.9%) remained stable, 3 cases(23.1%) progress. In BCNU group, 12cases (75.0%) remained stable 3 months later, 4 cases(25.0%) progress. 6 months later, 8 cases(50.0%) remained stable, 8 cases(50.0%) progress. The difference of progression between groups was statistically analyzed the log rank test. It shows that there was significant difference in 6 months group(p=0.03<0.05), no significant difference in 3 months group(p=0.129>0.05). Cox regression proportional hazard model were performed to analyze both the two 6-months groups. It demonstrated proportion of aging factor (p=0.036<0.05), 95% confidence intervals of which was 0.89～1.0; treating factor(p=0.001<0.005), 95% confidence intervals of which was 1.2～1.7; factors of gental and histological classification (p>0.05). Median progression of cases in ¹³¹I-chTNT group were more than 52 weeks, while cases in BCNU group was 24 weeks. KPS of the two groups were statistically analyzed by Wilconxon W test. There was no significant difference between two groups in KPS after operation(p=0.84>0.05) and 3 months(p=0.072>0.05). However ,there was significant difference between two groups in KPS after 6 months(p=0.040<0.05) and 12 months(p=0.047<0.05). Median survival of cases in ¹³¹I-chTNT group(>52weeks) was more long than cases in BCNU group significantly. COX regression proportional hazard model were performed to analyze both two groups. It demonstrated proportion of aging factor (p=0.010<0.05), 95% confidence intervals of which was 1.03～1.45; treating factor(p=0.012<0.05), 95% confidence intervals of which was 0.67～9.8; factors of histological classification(p=0.8>0.05), 5% confidence intervals of which was 1.73～4.34. In ¹³¹I-chTNT group, there were 4 cases of adverse reaction; 1 case of nausea after injection of drug, alieviated 10 minutes after 10mg metoclopramide intramuscular injection; 1 case of numbness and Broca aphasia immediately after injection, numbness dissapeared after 15 minutes; 1 case of scalp infection, healed after 1 week antibiotics treatment; 1 case platelet was 80×109/l. In BCNU group, there were 8 cases of adverse reaction; 3 cases leukocyte was less than 3.0×109/l; 1 case of phlebitis, healed after allopathy. Result of SPECT scan suggested that ¹³¹I mostly located in tumor, no ¹³¹I aggregation was observed in thyroid and bone marrow. No observed toxicity was related to HAMA in ¹³¹I-chTNT.Conclusion: Intratumoral radiotherapy by postoperative ¹³¹I-chTNT via Ommaya reservoir performs efficiently , demonstrates a significant virtue compared with BCNU group for recurrent high grade tumors. No observed toxicity was related to HAMA in ¹³¹I-chTNT. It is safe and untoxious on liver,kidney and bone marrow clinically.