淋巴结阳性食管癌术后预防性IMRT同期化疗的临床Ⅰ期研究  

Postoperative prophylactic concurrent radiochemotherapy for node-positive esophageal squamous cell carcinoma：a phase Ⅰ clinical study

作　　者：于舒飞[1] 章文成[1] 王奇峰[1] 肖泽芬[1] 周宗玫[1] 冯勤付[1] 陈东福[1] 张红星[1] 梁军[1] 惠周光[1] 吕纪马[1] 

机构地区：[1]北京协和医学院中国医学科学院肿瘤医院放疗科,100021

出　　处：《中华放射肿瘤学杂志》2016年第1期26-31,共6页Chinese Journal of Radiation Oncology

摘　　要：目的探讨淋巴结阳性食管癌术后预防性IMRT同期化疗的MTD和缩小靶区的影响。方法对2007--2011年在我院行根治性手术的33例胸中、下段食管鳞癌伴淋巴结转移患者行术后预防性IMRT同期化疗临床Ⅰ期研究。中位年龄52岁，76％为T3＋T4期。放疗随机分为60Cy分30次（2．0Gy／次）18例、54q分30次（1．8Gy／次）15例。化疗每周顺铂20ms／m2＋紫杉醇20、30、40、50mg／m2递增（每阶梯3例），连用5～6周。依据CTCAE3．0标准，DLT为4级白细胞下降或≥3级血红蛋白、血小板下降及≥3级非血液学不良反应。结果60Gy分30次（2．0Gy／次）组，紫杉醇20mg／m2时1例3级体重下降，增加3例后1例4级白细胞降低，递增实验失败。54Gy分30次（1．8Gy／次）组1例紫杉醇过敏中止化疗，其余20～40mg／m2无DLT，50mg／m2时2例4级白细胞和3级血小板下降而终止实验；MTD为每周顺铂20ms／m2＋紫杉醇40mg／m2连用5—6周。缩小靶区后60Gy分30次（2．0Gy／次）组12例无DLT，顺利完成递增实验；MTD为每周顺铂20mg／m2＋紫杉醇50mg／m2连用5—6周。靶区修改前、后平均PTV和残胃Dmean差异有统计学意义（P=0．006、0．013）。结论淋巴结阳性的胸中、下段食管癌术后预防性IMRT同期紫杉醇＋顺铂周方案在合理缩小靶区下是安全、有效的。Objective To investigate the maximum-tolerated dose （MTD） and target volume of postoperative prophylactic concurrent radiochemotherapy for lymph node-positive esophageal squamous cell carcinoma. Methods In this phase I clinical study, the 33 patients who had middle-lower thoracic esophageal squamous cell carcinoma with lymph node metastasis and received radical surgery in our hospital from July 25,2007 to December 31,2011 were enrolled. The median age was 52 years. The patients of T3 ＋T4 stage were 76%.The 33 patients were randomly divided into 60 Gy/2. 0 Gy/30f （n= 18） and 54 Gy/1.8 Gy/ 30f （ n = 15） for radiotherapy, and cis-platinum 20 mg/m2 per week＋Taxol 20,30,40,50 mg/m2 per week （1 weeks and 3 patients, respectively） were used in 5-6 consecutive weeks for concurrent chemotherapy. MTD was determined when grade 4 leucopenia, grade ≥ 3 reduction in hemoglobin and platelet, or grade ≥ 3 non-hematological toxicities occurred with CTCAE3.0 standard. Results In the group with a dose of 60 Gy/ 2.0 Gy/30f for radiotherapy, the initial dose of paclitaxel was 20 mg/m2 per week for concurrent chemotherapy,one patient experienced a dose-limiting toxicity （DLT） of grade 3 loss of body weight, and then another three patients experienced the same toxicity, among whom one experienced grade 4 leucopenia; thus,the dose escalation study failed. In the group with a dose of 54 Gy/1.8 Gy/30 f for radiotherapy,one patient experienced paclitaxel allergy and discontinued chemotherapy, and the dose of 20-40 mg/m2 per week escalation study was successful for each dose group ; however, a paclitaxel dose of 50 mg/m2 per week, 2 out of 3 patients experienced grade 4 leucopenia and grade 3 decrease in platelet, and therefore, the dose escalation study was terminated; MTD was determined as paclitaxel 40 mg/m2 per week plus cisplatin 20 mg/m2 per week for 5-6 consecutive weeks. CTV was also reduced, with the superior border of the thoracic vertebra T1 as the upper boundary and 3 cm below the tumor bed as the low

关 键 词：食管肿瘤/外科学 食管肿瘤/放射疗法 食管肿瘤/化学疗法 最大耐受剂量 剂量限制性毒性 

分 类 号：R735.1[医药卫生—肿瘤]