多西他赛与顺铂同期联合放疗和巩固化疗对Ⅲ期非小细胞肺癌Ⅰ期临床试验  

Toxicity of concurrent chemoradiotherapy and consolidation chemotherapy with docetaxel and cisplatin in stage Ⅲ non-small cell lung cancer：a phase Ⅰ trial

作　　者：包勇[1] 庄婷婷[2] 王卫华[3] 胡晓[1] 高剑铭[1] 何瀚[4] 孙宗文[4] 王彦[1] SHIVAJI Poudel 陈明[1] 

机构地区：[1]华南肿瘤学国家重点实验室中山大学肿瘤防治中心放疗科,广州510060 [2]汕头大学肿瘤医院放疗科 [3]澳门镜湖医院 [4]广东佛山市第一人民医院放疗科

出　　处：《中华放射肿瘤学杂志》2009年第5期362-366,共5页Chinese Journal of Radiation Oncology

基　　金：基金项目：广东省科技计划项目（2006836002011）

摘　　要：目的探讨多西他赛联合顺铂与放疗同期治疗Ⅲ期非小细胞肺癌的最大耐受剂量（MTD）和巩固化疗开始的合适时间，推荐Ⅱ期试验的方案。方法使用三维适形放疗，照射原发灶和阳性淋巴结区域60～70Gy分30—35次6—7周完成。化疗使用相同剂量的多西他赛和顺铂，MTD定义为≥2／6例患者出现剂量限制性毒性（DLT）的下一级剂量，同期化疗于放疗开始和第28天给药，起始剂量55mg／m^2，以后按10mg／m^2递增。巩固化疗剂量与同期化疗相同，时间为放疗结束后第4、5、6周给药，每3周重复，共两个疗程，如≥2／6例患者出现DLT则延至下1周。结果12例患者入组，均完成同期放化疗，其中6例于放疗结束后4周开始并完成2程巩固化疗。仅75mg／m^2组患者有2／3例发生DLT，主要副反应为中性粒细胞减少。结论推荐治疗Ⅲ期非小细胞肺癌的Ⅱ期试验中多西他赛联合顺铂方案同期＋巩固化疗剂量65mg／m^2，同期化疗4周重复；巩固化疗开始于放疗后第4周，3周重复，共2个疗程。Objective To investigate the maximal tolerated dose （MTD） of docetaxel and cisplatin （DC） combined with concurrent radiation therapy （RT）, and the appropriate interval between consolidation chemotherapy and concurrent chemoradiotherapy （CCRT） in patients with stage m non-small cell lung cancer （NSCLC）. Methods A total dose of 60 -70 Gy was delivered to the primary tumor and positive lymph node regions in 30 - 35 fractions by three dimensional conformal RT. Chemotherapy regimen consisted of docetaxel and cisplatin, which were administered at the same dose. MTD was defined as the dose level at which ≥2/6 patients developed dose-limiting toxicity （DLT）. Concurrent chemotherapy was administered on day 1 and day 28 of RT. The initial dose level was 55 mg/m^2, then increased by 10 mg/m^2 each time until to 75 mg/m^2. Consolidation chemotherapy at the same dose level was given 21 days per cycle for two cycles, which started 4, 5 or 6 weeks after RT. If ≥2/6 patients developed DLT during the consolidation chemotherapy, The second cycle would be postponed for 1 week. Results All of the 12 patients who enrolled in the trial completed CCRT. Among them, 6 patients successfully received 2 cycles consolidation chemotherapy 4 weeks after the completion of RT. No DLTs occurred until the dose level reached 75 mg/m^2. Two of three patients experienced DLT at the level of 75 mg/m^2. Neutropenia was the main adverse effect. Conclusions In the treatment of stage m NSCLC, a dose level of 65 mg/m^2 was recommended for phase Ⅱ study of CCRT and consolidation chemotherapy with docetaxel and cisplatin. Concurrent chemotherapy should be repeated every 4 weeks. Consolidation chemotherapy can be started 4 weeks after the completion of radiation and repeated every 3 weeks for 2 cycles.

关 键 词：癌 非小细胞肺/放射疗法 癌 非小细胞肺/化学疗法 综合疗法 Ⅰ期临床试验 

分 类 号：R686[医药卫生—骨科学]