医学
全直肠系膜切除术
直肠
危险系数
解剖(医学)
阶段(地层学)
结直肠癌
临床终点
淋巴结
外科
置信区间
随机对照试验
癌症
内科学
生物
古生物学
作者
Shin Fujita,Junki Mizusawa,Yukihide Kanemitsu,Masaaki Ito,Yusuke Kinugasa,Koji Komori,Masayuki Ohue,Mitsuyoshi Ota,Yoshihiro Akazai,Manabu Shiozawa,Tomohiro Yamaguchi,Hiroyuki Bandou,Kenji Katsumata,Kohei Murata,Yoshihito Akagi,Nobuhiro Takiguchi,Yoshihisa Saida,Kenichi Nakamura,Haruhiko Fukuda,Takayuki Akasu,Yoshihiro Moriya
出处
期刊:Annals of Surgery
[Ovid Technologies (Wolters Kluwer)]
日期:2017-03-11
卷期号:266 (2): 201-207
被引量:359
标识
DOI:10.1097/sla.0000000000002212
摘要
Objective: The aim of the study was to confirm the noninferiority of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) in terms of efficacy. Background: Lateral pelvic lymph node metastasis is occasionally found in clinical stage II or III lower rectal cancer, and ME with LLND is the standard procedure in Japan. ME alone, however, is the international standard surgical procedure for rectal cancer. Methods: Eligibility criteria included histologically proven rectal cancer at clinical stage II/III; main lesion located in the rectum, with the lower margin below the peritoneal reflection; no lateral pelvic lymph node enlargement; Peformance Status of 0 or 1; and age 20 to 75 years. Patients were intraoperatively allocated to undergo ME 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 endpoints included overall survival and local-recurrence-free survival. Analysis was by intention to treat. Results: In total, 701 patients were randomized to the ME with LLND (n = 351) and ME alone (n = 350) groups. The 5-year relapse-free survival in the ME with LLND and ME alone groups were 73.4% and 73.3%, respectively (hazard ratio: 1.07, 90.9% confidence interval 0.84–1.36), with a 1-sided P value for noninferiority of 0.0547. The 5-year overall survival, and 5-year local-recurrence-free survival in the ME 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 26 (7.4%) and 44 (12.6%) in the ME with LLND and ME alone groups, respectively (P = 0.024). Conclusions: The noninferiority of ME alone to ME with LLND was not confirmed in the intent-to-treat analysis. ME with LLND had a lower local recurrence, especially in the lateral pelvis, compared to ME alone.
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