全脑照射加Vm-26治疗肺癌脑转移的Ⅰ期临床试验  

Combined whole brain and radiotherapy with teniposide for brain metastasis of lung cancer:phase I clinical study

作　　者：周宗玫[1] 王绿化[1] 吕纪马[1] 王凯[1] 张红星[1] 殷蔚伯[1] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院放射治疗科,北京100021

出　　处：《中华放射肿瘤学杂志》2003年第4期228-230,共3页Chinese Journal of Radiation Oncology

摘　　要：目的　通过全脑照射加Vm 2 6综合治疗肺癌脑转移 ,观察其毒性、耐受剂量及临床可行性。方法　 16例患者为研究对象 ,全脑照射总剂量DT4 0Gy ,DT2Gy/次 ,5次 /周 ,2 0次共 4周。Vm 2 6分 5 0、75、10 0mg/m2 3个剂量级 ,每剂量组至少 3例 ,如无明显毒副反应进入下一剂量组 ,直至找到最大耐受量 (MTD) ,1次 /周 ,共 4次。结果　主要毒副反应为骨髓抑制。第 2个剂量级中有 2例出现 3、4级骨髓抑制 ,MTD为 75mg/m2 。结论　肺癌脑转移全脑照射加Vm 2 6综合治疗具有临床可行性 ,最大耐受剂量 75mg/m2 ,推荐Ⅱ期临床剂量为 5 0mg/m2 。Objective The current study was designed to determine the toxicity,maximal dose and clinical practicality of whole brain radiotherapy plus teniposide for brain metastasis from lung cancer. Methods Sixteen patients were alloted in phase I trial. The total dose was 40 ?Gy for whole brain radiotherapy (20 fractions of 2?Gy over four weeks). Teniposide at three dose levels (50?mg/m 2,75?mg/m 2 and 100?mg/m 2) was used,was given intravenously once a week over total four weeks. Dose escalation was based,on each level,of a minimum of three patients in cohort if severe toxicity had not been observed until the maximum tolerance dose(MTD). Results The predominant form of toxicity was hematologic toxicity. Two patients developed grade 3,4 leucopenia when a second level of MTD (75?mg/m 2)was given. Conclusions Combined whole brain radiotherapy and teniposide for brain metastasis from lung cancer is well tolerted. We recommend that the dose for phase Ⅱ clinical trial is 50?mg/m 2.

关 键 词：全脑照射 Vm—26 治疗 肺癌 脑转移 临床试验 

分 类 号：R730.5[医药卫生—肿瘤]