局部晚期直肠癌前切术后早期化放疗不良反应耐受性研究  

A clinical study to evaluate the toxicities of adjuvant chemoradiotherapy in early stage after lowanterior resection for locally advanced rectal cancer

作　　者：朱骥[1] 蔡钢[1] 李桂超[1] 孙文洁[1] 梁丽萍[1] 章真[1] 

机构地区：[1]复旦大学上海医学院肿瘤学系复旦大学附属肿瘤医院放疗科,上海200032

出　　处：《中华放射肿瘤学杂志》2011年第3期215-217,共3页Chinese Journal of Radiation Oncology

摘　　要：目的了解局部晚期直肠癌前切术患者术后早期化放疗的不良反应是否可耐受，并为下一步研究提供依据。方法对18～70岁、前切术、术后病理证实为直肠腺癌、病理分期T3-4或N＋期、无远处转移、KPS≥70患者且知情同意后纳入本研究。术后4周同期化放疗，不良反应评价标准为不良反应常见术语标准3．0版。三维适形放疗采用全盆腔照射45Gy后局部加量6～10Gy，静脉滴注奥沙利铂50mg／m2（1次／周）加口服希罗达625mg／m2（2次／d，第1—5天／周）增敏剂量化疗。本研究设计为单组2个阶段临床Ⅱ期研究，每阶段入组15例患者，以85％把握度出现≥3级不良反应率〉50％作为界限，即15例患者中出现9例不再继续入组。结果第一阶段入组15例患者中血液学不良反应3级2例，消化道3级反应12例，因此研究终止不再继续入组患者。结论局部晚期直肠癌前切术后采用奥沙利铂加希罗达增敏剂量化疗同期放疗时不良反应较重，需要进一步研究。Objective In the previous study completed in Korea, early three-dimensional conformal radiotherapy concurrent with chemotherapy in rectal cancer after radical surgery demonstrated a better prognosis compared with late radiotherapy. However, with the report of MOSAIC trial, the adjuvant chemotherapy regimen had transferred from 5-Fu alone to combined 5-Fu and Oxaliplatin. We need more evidence to clarify the best radiotherapy timing during the whole period of adjuvant therapy . Methods Patients who met the following criteria were accrued in this study：18 -70 years old, lower anterior resection, pathologically proven rectal adenocarcinoma, stage T3-4 and/or N ＋ , no evidence of distant metastases and KPS≥70. Three dimensional conformal Radiotherapy was started at the fourth week after surgery, which included 45 Gy whole pelvic radiation following by 6 - 10 Gy tumor bed boost. Oxaliplatin of 50 mg/m2 weekly and Xeloda 625 mg/m： twice a day, every week from d1-5 were used concurrent with radiotherapy. Toxicity was evaluated and graded by common toxicity critera version 3.0. The study was designed as Simon two-phase design, in the first phase, a total of 15 patients were accrued, and if more than or equal to 9 patients had grade 3 toxicity, we had 85% power to confirm the toxicity caused by early radiotherapy more than 50%. Otherwise, another 15 patients of the second phase were accrued, we would have 85% power to confirm the high toxicity of more than 50% if 18 out of 30 patients had grade 3 toxicity. Results From July 2008 to December 2008, 15 patients were treated with early radiotherapy concurrent with combined chemotherapy. Grade 3 gastrointestinal toxicity occurred in 12 patients and Grade 3 hematologic toxicity occurred in 2 patients. According to Simon design, we had 85% power to confirm the toxicity caused by early radiotherapy more than 50%. Conclusions For locally advanced rectal cancer patients, whole pelvic radiotherapy concurrent with oxaliplatin and xeloda had severe toxicities. Further studies

关 键 词：直肠肿瘤/化放疗法 不良反应 耐受性 

分 类 号：R735[医药卫生—肿瘤]