首页> 中文期刊> 《中国全科医学》 >全脑放疗联合伊立替康治疗非小细胞肺癌脑转移的Ⅰ期临床试验研究

全脑放疗联合伊立替康治疗非小细胞肺癌脑转移的Ⅰ期临床试验研究

摘要

目的:探讨全脑放疗联合伊立替康(CPT-11)治疗非小细胞肺癌(NSCLC)脑转移的剂量限制性毒性( DLT)、最大耐受剂量( MTD)及其临床疗效。方法选取2009年10月-2012年11月南昌大学第一附属医院肿瘤科经病理或细胞学证实的晚期NSCLC脑转移患者27例,采用全脑放疗联合CPT-11治疗,每周一至周五行全脑常规分割放疗,全脑剂量40 Gy/20次,分次剂量2 Gy;放射治疗的第1周开始应用CPT-11,每周六用药1次,共治疗4周。 CPT-11分6个剂量组:25 mg/m2组,50 mg/m2组,65 mg/m2组,80 mg/m2组,100 mg/m2组,120 mg/m2组。每个试验组至少入选3例患者,如在前一个剂量水平中患者无明显毒副作用则进入下一个剂量组,直至达到MTD。结果27例患者均完成治疗,可评价疗效,3例完全缓解(CR),17例部分缓解(PR),7例无变化(SD),总有效率为74.1%(20/27)。 DLT为白细胞计数下降、血小板计数下降及腹泻。试验得出MTD为100 mg/m2。结论全脑放疗联合CPT-11治疗NSCLC脑转移推荐Ⅱ期临床剂量为80 mg/m2。%ObjectiveTodeterminethedose-limitingtoxicities(DLT),maximumtolerateddose(MTD)andclini-cal effect of CPT-11 combined with whole brain radiotherapy ( WBRT) for patients with brain metastases of non -small cell lung cancer(NSCLC).Methods 27withpathologicallyorcytologicallyconfirmedmetastasesofNSCLCadmittedtoDepartmentof Oncology of the First Affiliated Hospital of Nanchang University from October 2009 to November 2012 were treated with WBRT and CPT-11.The patients were given fractionated radiotherapy from every Monday to Friday , with daily fraction of 2 Gy per week and a total radiation dose of 40 Gy.CPT -11 was given at the first week , with the drug administered every Saturday for four weeks.The dose of CPT-11 was categorized into six groups: 25 mg/m2 group, 50 mg/m2 group, 65 mg/m2 group, 80 mg/m2 group, 100 mg/m2 group and 120 mg/m2 group.Each group had at least 3 cases, and the dose of CPT-11 would be increased to the next level if it was safe with the lower level until it reached MTD .Results All 27 cases completed the treatment and could be evaluated in terms of clinical effect .3 cases had complete remission , 17 cases had partial remission and 7 cases had no significant difference, and the total effect was 74.1%(20/27) .DLT was the decreasing of white blood cell count and blood platelet count , as well as diarrhea.The MTD was 100 mg/m2.Conclusion The dose for phase Ⅱis 80 mg/m2 in the treatment of patients with brain metastases of NSCLC with WBRT combined with CPT -11.

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