直肠系膜侧方淋巴结清除术对临床Ⅱ/Ⅲ期低位直肠癌治疗的影响

The effect of lateral lymph node dissection on the treatment of stageⅡ/Ⅲlow rectal cancer with mesorectal excision

目的比较单独使用直肠系膜切除术(ME)和ME附加侧淋巴结清除术(LLND)在治疗临床Ⅱ/Ⅲ期低位直肠癌疗效上的非劣效性。方法选择组织学证实的临床Ⅱ/Ⅲ期直肠癌患者,采用意向性治疗分析方法,根据意向分配单独接受ME治疗或LLND-ME治疗。主要统计分析终点是无复发生存期危险比为1.34的非劣效性,次要统计分析终点包括总生存期和无局部复发生存期。结果2010年4月11日至2017年10月1日收集的502例患者中252例患者为LLND-ME组,250例患者为ME组。LLND-ME组的患者5年无复发生存率为73.4%,ME组为73.3%(危险比:1.07,90.9%CI0.84~1.36),非劣效性的单侧P值为0.0547。在LLND-ME组中,5年总生存期和5年中位无局部复发生存率分别为92.6%和90.2%,ME组中为87.7%和82.4%。LLND-ME组和ME单独组局部复发患者例数分别为21例(8.3%)和43例(17.2%)(P=0.024)。结论在意向性治疗分析中未证实ME单独使用与LLND联用的非劣效性。但在侧骨盆中,与单独的ME相比,LLND与ME联用具有更低的局部复发率。

Objective To confirm the noninferiority of mesorectal excision(ME)alone to ME combined with lateral lymph node dissection(LLND)in terms of efficacy.MethodsEligibility criteria included histologically proven rectal cancer at clinical stageⅡ/Ⅲ;main lesion located in the rectum.Patients were intra-operatively allocated to undergo ME combined with LLND or ME alone in a randomized manner.The primary endpoint was relapse-free survival,with a noninferiority margin for the hazard ratio of 1.34.Secondary end points included overall survival and local-recurrence-free survival.ResultsIn total,502 patients from November 11,2010 to October 1,2017 were randomized to the ME combined with LLND(252 patients)and ME alone(250 patients)groups.The 5-year relapse-free survival in the ME combined with LLND and ME alone groups were 73.4%and 73.3%,respectively(hazard ratio:1.07,90.9%CI 0.84-1.36),with one sided P value for noninferiority of 0.0547.The 5-year overall survival,and 5-year local-recurrence-free survival in the ME combined with LLND and ME alone groups were 92.6%and 90.2%,and 87.7%and 82.4%,respectively.The numbers of patients with local recurrence were 21 cases(8.3%)and 43 cases(17.2%)in the ME combined with LLND group and ME alone group(P=0.024).ConclusionsThe noninferiority of ME alone to ME combined with LLND is not confirmed in the intent-to-treat analysis.ME combined with LLND has a lower local recurrence,especially in the lateral pelvis,compared to ME alone.