医脉通编译，转载请务必注明出处
2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会在芝加哥举办。6月5日上午的消化系统（结直肠）肿瘤口头报告专场上，一项摘要号为3508的日本临床肿瘤学小组研究JCOG0212的主要终点分析，在临床II期，III期低位直肠癌中将直肠系膜切除术联合或不联合外侧淋巴结清扫进行比较，医脉通整理如下：
直肠系膜切除术（ME）是低位直肠癌的标准手术。然而，由于外侧盆腔淋巴结转移偶尔被发现，ME联合外侧淋巴结清扫（LLND）在日本是标准手术。研究人员开展了一项随机试验以证实ME单独应用与ME联合LLND在疗效方面的非劣效性，报告显示与ME+LLND组相比较，ME组趋向于出现较低的术后并发症发生率。这是将无复发生存期（RFS）作为主要终点的初步分析。
符合条件的标准包括经组织学证实的直肠癌；临床II/III期；主要病灶位于直肠和腹膜反射下缘；没有外侧盆腔淋巴结肿胀；PS为0或1分；患者年龄20-75岁。外科医生通过ME术式证实R0切除后，患者被随机在术中分配接受单独ME或者ME+LLND。主要终点是RFS，风险比（HR）非劣效性界值为1.34。计划的样本量为700例，75%的P值，单侧α为5%。
一共有来自33家机构的701例患者入组，他们在2003年6月到2010年8月被随机分配接受ME+LLND（n=351）或者ME（n=350）。5年RFS在ME+LLND组和ME组分别为73.4%和73.3%。HR是1.07[90.9% CI 0.84-1.36（＞1.34）]；因此ME的非劣效性未被证实（P=0.055）。5年总存活率（OS）和5-年局部无复发存活率（LRFS）如表所示。局部复发患者的数量在ME+LLND组和ME组分别为25（7.1%）和44（12.6%）（P=0.02）。
综上所述，直肠系膜切除术相比于直肠系膜切除术联合外侧淋巴结清扫的非劣效性未得到证实。与单独直肠系膜切除术相比较，直肠系膜切除术联合外侧淋巴结清扫可以显著降低术后局部复发。临床试验信息：C000000034。
会议专题》》》2016年ASCO年会专题报道
原文摘要：
A randomized trial comparing mesorectal excision with or without lateral lymph node dissection for clinical stage II, III lower rectal cancer: Primary endpoint analysis of Japan Clinical Oncology Group study JCOG0212.（Abstract3508）
Authors：Shin Fujita, Junki Mizusawa,et al
Session Type：Oral Abstract Session
Background: Mesorectal excision (ME) is the standard surgery for lower rectal cancer. However, lateral pelvic lymph node metastasis is occasionally found, and ME with lateral lymph node dissection (LLND) is the standard procedure in Japan. We conducted a randomized trial to confirm the non-inferiority of ME alone to ME with LLND in terms of efficacy and reported the ME group tended to show lower postoperative morbidity than the ME+LLND group. This is the primary analysis of the relapse-free survival (RFS) as the primary endpoint.
Methods: Eligibility criteria included histologically proven rectal cancer; clinical stage II/III; main lesion located in the rectum and the lower margin below the peritoneal reflection; no lateral pelvic lymph node swelling; PS of 0 or 1; patient age 20-75 years. After surgeons had confirmed R0 resection by the ME procedure, patients were randomized intraoperatively to ME alone or ME with LLND. The primary endpoint was RFS and the non-inferiority margin of the hazard ratio (HR) was 1.34. The planned sample size was 700 with a power of 75% and a one-sided alpha of 5%.
Results: A total 701 patients enrolled from 33 institutions were randomized to ME+LLND (n=351) or ME (n=350) between June 2003 and August 2010. The 5-year RFS was 73.4% and 73.3% in the ME+LLND group and the ME group, respectively. The HR was 1.07 [90.9% CI 0.84-1.36 (>1.34)]; thus the non-inferiority of ME was not confirmed (p=0.055). The 5-year overall survival (OS) and the 5-year local-recurrence-free survival (LRFS) were shown in the Table. The numbers of patients with local recurrence were 25 (7.1%) and 44 (12.6%) in the ME+LLND group and the ME group, respectively (p=0.02).
Conclusions: The non-inferiority of ME to ME with LLND was not confirmed. ME with LLND significantly reduced local recurrence after surgery compared with ME alone. Clinical trial information: C000000034.
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