早期食管鳞癌内镜下R0切除后追加放(化)疗与食管癌根治术的比较分析:来自ECETC协作研究组的多中心研究

Comparative analysis of endoscopic R0 resection followed by additional chemoradiotherapy for early stage esophageal cancer compared with esophagectomy:A multi-center study from ECETC

目的研究内镜下R0切除追加放(化)疗的策略在M3～T1b期食管癌中的应用可能。方法纳入来自食管癌内镜下治疗协作研究组(ECETC)的M3～T1b的早期食管癌患者45例作为试验组,行内镜R0切除追加术后放(化)疗,男34例、女11例,年龄(61.37±7.14)岁;选取复旦大学附属肿瘤医院行食管癌根治术T1期患者90例作为对照组,男63例、女27例,年龄(61.04±8.17)岁。经过1∶2倾向评分匹配,均衡性别、年龄、肿瘤部位、浸润深度与淋巴血管侵犯(LVI)等因素,比较两组总体生存率、无复发生存率以及局部复发率的差异。结果两组患者总体生存率差异并无统计学意义[HR(95%CI)=2.66(0.87～8.11),P=0.179]。对照组1年、2年和3年总体生存率分别为93%,86%和84%;内镜追加放(化)疗组3年内尚无死亡病例。两组术后无复发生存率差异无统计学意义[HR(95%CI)=1.48(0.66～3.33),P=0.389],其中对照组1年、2年和3年无复发生存率分别为87%,78%和76%,试验组97%,93%和73%。两组术后局部复发率差异亦无统计学意义[HR(95%CI)=0.53(0.13～2.18),P=0.314],其中对照组1年、2年和3年局部复发率为5%,6%和6%,试验组为0%,0%和21%。结论两组总生存率与无复发生存率以及局部复发率相似。内镜下R0切除追加放(化)疗在M3～T1b分期食管癌的治疗中有一定的应用前景,该策略可以成为一些有手术高危因素以及手术不耐受患者的另一选择方案。

Objective To evaluate the strategy of chemoradiotherapy following endoscopic R0 resection for esophageal cancer in M3-Tlb stage. Methods There were 45 esophageal cancer patients with M3-Tlb stage with endoscopic R0 resection followed by additional chemoradiotherapy from ECETC （Esophageal Cancer Endoscopic Therapy Consortium） as a trial group with 34 males and 11 females at age of 61.37±7.14 years. There were 90 patients with esophagectomy from Fudan University Shanghai Cancer Center as a control group with 63 males and 27 females at age of 61.04±8.17 years. Propensity score match （1：2） was used to balance the factors： gender, age, position, depth of invasion and lymphovascular invasion （LVI）, which may influence the outcomes. Overall survival （OS） rate, relapse free survival （RFS） rate, and local recurrence rate were compared between the two groups. Result There was no statistical difference （HR=2.66 with 95%CI 0.87 to 8.11, P=0.179） in terms of OS rate between the two groups. One, two and three years overall survival rate of patients in the control group was 93%, 86%, and 84%, respectively. Nobody died in the trial group within 3 years after surgery. The RFS rate between the two groups didn＇t significantly differ （HR=1.48, 95% CI 0.66 to 3.33, P=0.389）. One, two and three years RFS rate of patients in the contorl group was 87%, 78%, and 76%, respectively, while 97%, 93%, and 73% in the trial group, respectively. The local recurrence rates between the two groups didn＇t significantly differ either （ HR=0.53, 95%CI 0.13 to 2.18, P=0.314）. One, two and three years local recurrence rate of patients in the control group was 5%, 6% and 6%, respectively, while 0%, 0% and 21% in the trial group, respectively. Conclusion Similar outcomes are found regarding OS, RFS and local recurrence rates between the two groups. The strategy of endoscopic R0 resection followed by additional chemoradiotherapy has prospect for the treatment of esophageal cancer in M3-Tlb stage. And this kind of therapy may be provided for those with risk factors or can not tolerate surgery