S Tsukamoto1, S Fujita2, M Ota3, J Mizusawa4, D Shida1, Y Kanemitsu1, M Ito5, A Shiomi6, K Komori7, M Ohue8, Y Akazai9, M Shiozawa10, T Yamaguchi11, H Bando12, A Tsuchida13, S Okamura14, Y Akagi15, N Takiguchi16, Y Saida17, T Akasu18, Y Moriya19. 1. Department of Colorectal Surgery, Tokyo Medical University Hospital, Tokyo, Japan. 2. Department of Surgery, Tochigi Cancer Centre, Tochigi, Japan. 3. Department of Surgery, Yokohama City University Medical Centre, Kanagawa, Japan. 4. Japan Clinical Oncology Group Data Centre and Operations Office, National Cancer Centre Hospital, Tokyo Medical University Hospital, Tokyo, Japan. 5. Colorectal Surgery Division, National Cancer Centre Hospital East, Chiba, Japan. 6. Division of Colon and Rectal Surgery, Shizuoka Cancer Centre Hospital, Shizuoka, Japan. 7. Department of Surgery, Aichi Cancer Centre Hospital, Aichi, Japan. 8. Department of Gastroenterological Surgery, Suita Municipal Hospital, Osaka International Cancer Institute, Japan. 9. Department of Surgery, Okayama Saiseikai General Hospital, Okayama, Japan. 10. Department of Surgery, Kanagawa Cancer Centre, Kanagawa, Japan. 11. Department of Surgery, Kyoto Medical Centre, Kyoto, Japan. 12. Department of Surgery, Ishikawa Prefectural Central Hospital, Ishikawa, Japan. 13. Department of Surgery, Tokyo Medical University Hospital, Tokyo, Japan. 14. Department of Surgery, Suita Municipal Hospital, Osaka, Japan. 15. Department of Surgery, Kurume University, Fukuoka, Japan. 16. Department of Gastrointestinal Surgery, Chiba Cancer Centre, Chiba, Japan. 17. Department of Surgery, Toho University Ohashi Medical Centre, Tokyo, Japan. 18. Hospital of the Imperial Household, Tokyo, Japan. 19. Department of Surgery, Miki Hospital, Iwate, Japan.
Abstract
BACKGROUND:Japan Clinical Oncology Group (JCOG) 0212 (ClinicalTrials.gov NCT00190541) was a non-inferiority phase III trial of patients with clinical stage II-III rectal cancer without lateral pelvic lymph node enlargement. The trial compared mesorectal excision (ME) with ME and lateral lymph node dissection (LLND), with a primary endpoint of recurrence-free survival (RFS). The planned primary analysis at 5 years failed to confirm the non-inferiority of ME alone compared with ME and LLND. The present study aimed to compare ME alone and ME with LLND using long-term follow-up data from JCOG0212. METHODS:Patients with clinical stageII-III rectal cancer below the peritoneal reflection and no lateral pelvic lymph node enlargement were included in this study. After surgeons confirmed R0 resection by ME, patients were randomized to receive ME alone or ME with LLND. The primary endpoint was RFS. RESULTS: A total of 701 patients from 33 institutions were assigned to ME with LLND (351) or ME alone (350) between June 2003 and August 2010. The 7-year RFS rate was 71.1 per cent for ME with LLND and 70·7 per cent for ME alone (hazard ratio (HR) 1·09, 95 per cent c.i. 0·84 to 1·42; non-inferiority P = 0·064). Subgroup analysis showed improved RFS among patients with clinical stage III disease who underwent ME with LLND compared with ME alone (HR 1·49, 1·02 to 2·17). CONCLUSION: Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND. ME with LLND is recommended for patients with clinical stage III disease, whereas LLND could be omitted in those with clinical stage II tumours.
RCT Entities:
BACKGROUND: Japan Clinical Oncology Group (JCOG) 0212 (ClinicalTrials.gov NCT00190541) was a non-inferiority phase III trial of patients with clinical stage II-III rectal cancer without lateral pelvic lymph node enlargement. The trial compared mesorectal excision (ME) with ME and lateral lymph node dissection (LLND), with a primary endpoint of recurrence-free survival (RFS). The planned primary analysis at 5 years failed to confirm the non-inferiority of ME alone compared with ME and LLND. The present study aimed to compare ME alone and ME with LLND using long-term follow-up data from JCOG0212. METHODS:Patients with clinical stage II-III rectal cancer below the peritoneal reflection and no lateral pelvic lymph node enlargement were included in this study. After surgeons confirmed R0 resection by ME, patients were randomized to receive ME alone or ME with LLND. The primary endpoint was RFS. RESULTS: A total of 701 patients from 33 institutions were assigned to ME with LLND (351) or ME alone (350) between June 2003 and August 2010. The 7-year RFS rate was 71.1 per cent for ME with LLND and 70·7 per cent for ME alone (hazard ratio (HR) 1·09, 95 per cent c.i. 0·84 to 1·42; non-inferiority P = 0·064). Subgroup analysis showed improved RFS among patients with clinical stage III disease who underwent ME with LLND compared with ME alone (HR 1·49, 1·02 to 2·17). CONCLUSION: Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND. ME with LLND is recommended for patients with clinical stage III disease, whereas LLND could be omitted in those with clinical stage II tumours.
Authors: Michael K Turgeon; Adriana C Gamboa; Jessica M Keilson; Jeffrey Maniko; Lillias Maguire; Katherine Hrebinko; Jennifer Holder-Murray; Jason T Wiseman; Sherif Abdel-Misih; Saif Hamdan; Alexander T Hawkins; Philip Bauer; Matthew Silviera; Shishir K Maithel; Glen C Balch Journal: J Surg Oncol Date: 2021-07-16 Impact factor: 2.885