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

摘要

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% CI 0.84~1.36),非劣效性的单侧P值为0.054 7.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. Methods Eligibility 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. Results In 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). Conclusions The 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.