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.
The findings of the lymph flow pattern of splenic flexure suggest that lymph node dissection at the root of the IMV area is important, and it may be not necessary to ligate both the lt-MCA and LCA, at least in cases without widespread lymph node metastases.
Background
Japan Clinical Oncology Group (JCOG) 0212 (http://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.
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