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局部晚期直肠癌术前含草酸铂同步放化疗Ⅱ期临床研究

A phase Ⅱ trail of preoperative concurrent chemoradiotherapy in locally advanced rectal cancer with oxaliplatin-containing regimen

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【作者】 刘鲁迎朱远吴列李德川冯海洋鞠海星

【机构】 浙江省肿瘤医院放射治疗科浙江省肿瘤医院大肠外科

【摘要】 目的:评价术前同步放射治疗与草酸铂和5-氟尿嘧啶/甲酰四氢叶酸钙联合化疗治疗局部晚期直肠癌的耐受性和有效性。方法:自2002年2月至2005年11月,58例初诊时估计无法行根治切除术的局部晚期直肠癌(T3-T4)患者进入该研究。其中男性38例,女性20例,年龄为23-72岁 (中位年龄49岁)。治疗前均获取病理,其中腺癌54例,印戒细胞癌4例。放射治疗为三野等中心技术,盆腔照射46Gy/ 23次/4.5周。在放射治疗第1周和第4周同步给予2个周期的化疗,草酸铂130 mg/m2/d1,5-FU500 mg/m2/d1- 3和CF200 mg/m2/d1-3。放射治疗结束后4-6周进行手术。结果:完成原定治疗计划并行手术者55例。11/55例(20%) 患者手术标本中肿瘤全消(pCR),21/55例(38.2%)患者中仅检出少量残存肿瘤细胞。3级毒性反应包括中性粒细胞减少1例,腹泻3例,放射性直肠炎4例,肝功能异常1例, 未发生4级以上毒性反应。结论:含草酸铂方案的术前联合放化疗耐受性良好,有效率高,应进一步随访并开展Ⅲ期期临床试验,明确对局控率和生存率的影响。

【Abstract】 Objective: To evaluate the toleration and efficacy of preoperative concurrent chemoradiotherapy in locally advanced rectal cancer with oxaliplatin and 5-flurouraeil/calcium folinate(5-fu/CF). Methods: Between February 2002 and November 2005,58 un-operable patients were entered onto the study. Of which, 38 cases were male and 20 cases were female. The range of age was from 23 to 72 years old. Radiotherapy were delivered with a three-field technique to a dose of 46 Gy over 4.5 weeks. Two cycles of chemotherapy were given synchronously on weeks 1 and 4, with oxaliplatin 130mg/m2 on day 1 and calcium folinate 200mg/m2 followed by 5-flurouracil 500mg/m2 on day 1 to 3. Surgery was planned 4 to 6 weeks later. Results: 55 patients completed treatment without modification, and surgery was performed in 55patients . An objective clinical response was seen in 32 patients(58. 2%). Grade 3 toxicity was seen in 8 patients. No postoperative deaths and grade 4 toxicity occurred. Conclusion: Such a combined preoperative concurrent chemoradiotherapy in locally advanced rectal cancer with oxaliplatin-containing regimen is well tolerated with no increase in surgical toxicity. The good response rate observed warrants its use in further clinical trails.

【关键词】 直肠肿瘤放射疗法化学疗法
  • 【会议录名称】 第四届中国肿瘤学术大会暨第五届海峡两岸肿瘤学术会议论文集
  • 【会议名称】第四届中国肿瘤学术大会暨第五届海峡两岸肿瘤学术会议
  • 【会议时间】2006-10
  • 【会议地点】中国天津
  • 【分类号】R735.3
  • 【主办单位】中国抗癌协会、中华医学会肿瘤学分会
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