CAJ | 학술논문

目的探讨术中联合125Ⅰ粒子植入治疗胸段中晚期食管鳞状细胞癌(ESCC)的安全性及疗效.方法前瞻性队列研究,入组时间为2000年1月至2004年8月.298例Ⅱ～Ⅲ期胸段ESCC患者随机分为术中联合125Ⅰ粒子植入组(A组,150例)及单纯手术组(B组,148例).A组术中直视下植入125Ⅰ粒子,术后通过CT和胸部X线片行粒子验证和质量评估.所有患者根据术中情况行食管癌根治术、姑息减瘤术或食管胃转流术.临床观察患者术后并发症,CT监测肿瘤影像学和局部复发情况,按WHO相关肿瘤评定标准评价患者近期疗效,随访术后1、3、5和7年生存率.结果随访截至2008年8月31日,中位随访42个月(95%CI:37～55个月).A组术后粒子验证无移位、脱落,质量评估满意.A组及B组局部复发率分别为14.9%、38.7%,差异有统计学意义(P<0.05).术后3个月,A组有效率78.8%,与B组30.3%比较差异有统计学意义(P<0.05).两组并发症差异无统计学意义(P>0.05).A组及B组的3、5和7年生存率分别为64.0%比52.0%、42.7%比34.5%、25.1%比12.6%,差异有统计学意义(P<0.05).结论术中联合125Ⅰ粒子植入治疗中晚期ESCC是简单、安全、有效的方法,可降低局部复发率、延长患者生存期.
목적 탐토술중연합125Ⅰ입자식입치료흉단중만기식관린상세포암(ESCC)적안전성급료효.방법 전첨성대렬연구,입조시간위2000년1월지2004년8월.298례Ⅱ～Ⅲ기흉단ESCC환자수궤분위술중연합125Ⅰ입자식입조(A조,150례)급단순수술조(B조,148례).A조술중직시하식입125Ⅰ입자,술후통과CT화흉부X선편행입자험증화질량평고.소유환자근거술중정황행식관암근치술、고식감류술혹식관위전류술.림상관찰환자술후병발증,CT감측종류영상학화국부복발정황,안WHO상관종류평정표준평개환자근기료효,수방술후1、3、5화7년생존솔.결과 수방절지2008년8월31일,중위수방42개월(95%CI:37～55개월).A조술후입자험증무이위、탈락,질량평고만의.A조급B조국부복발솔분별위14.9%、38.7%,차이유통계학의의(P<0.05).술후3개월,A조유효솔78.8%,여B조30.3%비교차이유통계학의의(P<0.05).량조병발증차이무통계학의의(P>0.05).A조급B조적3、5화7년생존솔분별위64.0%비52.0%、42.7%비34.5%、25.1%비12.6%,차이유통계학의의(P<0.05).결론 술중연합125Ⅰ입자식입치료중만기ESCC시간단、안전、유효적방법,가강저국부복발솔、연장환자생존기.
Objective To evaluate the safety and efficacy of the united intraoperative 125Ⅰ seed implantation as a treatment option for thoracic advanced esophageal squamous cell carcinoma (ESCC).Methods From January 2000 to August 2004, according to preoperative CT staging criteria,298 patients in phase Ⅱ to Ⅲ of ESCC had been enrolled in this prospective study. With informed consent, they were randomized into two groups: intraoperative 125Ⅰ seed implantation (group A) and surgery alone (group B).With 0.5 mCi of single seed, total activity in 10 to 30 mCi, matched peripheral dose in 60 to 70 Gy, 20 to 40 125Ⅰ seeds were implanted into the target under direct vision in accordance with treatment planning system.The post-operative complications were observed. The validation and quality assessment of radioactive seeds were demonstrated according to CT scan or X imaging. The short-term efficacy was evaluated according to WHO criteria. The 1-, 3-, 5-, and 7-year survival rate were followed up. Results On the close date of August 31 st 2008, the satisfied quality assessment of 125 Ⅰ seeds was observed. There was no displacement or loss of seed. The local recurrence rates in the group A and group B were 14. 9% and 38. 7%, respectively,which were statistically significant ( P < 0. 05 ). The complete response and partial response rate in the group A was 78. 8%. It was significantly higher than 30. 3% in the group B (P <0. 05). There was no statistical difference among groups when comparing the complications ( P > 0. 05 ). The 1-year survival rates were no statistical difference among the two groups. However, the 3-, 5-, and 7-year survival rates in group A (64. 0%, 42. 7%, and 25. 1% ) were statistically different from that in the B group (52. 0%, 34. 5%, and 12. 6% ) (P < 0. 05). Conclusions It is safe, effective and simple application about the intraoperative 125Ⅰseed implantation for advanced ESCC. It may reduce the local recurrence rate and improve survival.