Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212) A Multicenter, Randomized Controlled, Noninferiority Trial

被引：424

作者：

Fujita, Shin ^{[1
]}

Mizusawa, Junki ^{[2
]}

Kanemitsu, Yukihide ^{[3
]}

Ito, Masaaki ^{[4
]}

Kinugasa, Yusuke ^{[5
]}

Komori, Koji ^{[6
]}

Ohue, Masayuki

Ota, Mitsuyoshi ^{[7
,8
]}

Akazai, Yoshihiro ^{[9
]}

Shiozawa, Manabu ^{[10
]}

Yamaguchi, Takashi ^{[11
]}

Bandou, Hiroyuki ^{[12
]}

Katsumata, Kenji ^{[13
]}

Murata, Kohei ^{[14
]}

Akagi, Yoshihito ^{[15
]}

Takiguchi, Nobuhiro ^{[16
]}

Saida, Yoshihisa ^{[17
]}

Nakamura, Kenichi ^{[2
]}

Fukuda, Haruhiko ^{[2
]}

Akasu, Takayuki ^{[18
,20
]}

Moriya, Yoshihiro ^{[19
,21
]}

机构：

[1] Tochigi Canc Ctr, Dept Surg, 4-9-13 Yohnan, Utsunomiya, Tochigi, Japan

[2] Natl Canc Ctr, Operat Off, JCOG Data Center, Tokyo, Japan

[3] Natl Canc Ctr, Colorectal Surg Div, Tokyo, Japan

[4] Natl Canc Ctr Hosp East, Dept Colorectal Surg, Chiba, Japan

[5] Shizuoka Canc Ctr, Dept Surg, Shizuoka, Japan

[6] Aichi Canc Ctr Hosp, Dept Surg, Nagoya, Aichi, Japan

[7] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Surg, Osaka, Japan

[8] Yokohama City Univ, Med Ctr, Dept Surg, Yokohama, Kanagawa, Japan

[9] Okayama Saiseikai Gen Hosp, Dept Surg, Okayama, Japan

[10] Kanagawa Canc Ctr, Dept Surg, Yokohama, Kanagawa, Japan

[11] Kyoto Med Ctr, Dept Surg, Kyoto, Japan

[12] Ishikawa Prefectural Cent Hosp, Dept Surg, Kanazawa, Ishikawa, Japan

[13] Tokyo Med Univ Hosp, Dept Surg, Tokyo, Japan

[14] Suita Municipal Hosp, Dept Surg, Osaka, Japan

[15] Kurume Univ, Dept Surg, Sch Med, Fukuoka, Japan

[16] Chiba Canc Ctr Hosp, Dept Surg Gastroenterol, Chiba, Japan

[17] Toho Univ, Ohashi Med Ctr, Dept Surg, Tokyo, Japan

[18] Hosp Imperial Household, Tokyo, Japan

[19] Japanese Red Cross Med Ctr, Tokyo, Japan

[20] Hosp Imperial Household, Dept Surg, Tokyo, Japan

[21] Japanese Red Cross Med Ctr, Dept Surg, Tokyo, Japan

来源：

ANNALS OF SURGERY | 2017年 / 266卷 / 02期

关键词：

lateral lymph node dissection; randomized trial; rectal cancer; PREOPERATIVE CHEMORADIOTHERAPY; LOCAL RECURRENCE; MAJOR CAUSE; INVOLVEMENT; COLON;

D O I：

10.1097/SLA.0000000000002212

中图分类号：

R61 [外科手术学];

学科分类号：

100210 [外科学];

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.

引用

页码：201 / 207

页数：7

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