• Shin Fujita, Junki Mizusawa, Yukihide Kanemitsu, Masaaki Ito, Yusuke Kinugasa, Koji Komori, Masayuki Ohue, Mitsuyoshi Ota, Yoshihiro Akazai, Manabu Shiozawa, Takashi Yamaguchi, Hiroyuki Bandou, Kenji Katsumata, Kohei Murata, Yoshihito Akagi, Nobuhiro Takiguchi, Yoshihisa Saida, Kenichi Nakamura, Haruhiko Fukuda, Takayuki Akasu, Yoshihiro Moriya, and Colorectal Cancer Study Group of Japan Clinical Oncology Group.
• *Department of Surgery, Tochigi Cancer Center, Tochigi, Japan †JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan ‡Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan §Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan ¶Department of Surgery, Shizuoka Cancer Center, Shizuoka, Japan ||Department of Surgery, Aichi Cancer Center Hospital, Nagoya, Japan **Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan ††Department of Surgery, Yokohama City University Medical Center, Kanagawa, Japan ‡‡Department of Surgery, Okayama Saiseikai General Hospital, Okayama, Japan §§Department of Surgery, Kanagawa Cancer Center, Kanagawa, Japan ¶¶Department of Surgery, Kyoto Medical Center, Kyoto, Japan ||||Department of Surgery, Ishikawa Prefectural Central Hospital, Ishikawa, Japan ***Department of Surgery, Tokyo Medical University Hospital, Tokyo, Japan †††Department of Surgery, Suita Municipal Hospital, Osaka, Japan ‡‡‡Department of Surgery, Kurume University School of Medicine, Fukuoka, Japan §§§Department of Gastroenterological Surgery, Chiba Cancer Center Hospital, Chiba, Japan ¶¶¶Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan ||||||Hospital of the Imperial Household, Tokyo, Japan ****Japanese Red Cross Medical Center, Tokyo, Japan.
• Ann. Surg. 2017 Aug 1; 266 (2): 201-207.

ObjectiveThe 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.BackgroundLateral 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.MethodsEligibility 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.ResultsIn 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).ConclusionsThe 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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