OA06-LBA01.1. Radical 3-Field Versus Standard 2-Field Lymphadenectomy for Operable Esophageal Cancer: A Randomized Controlled Trial

Topic Esophageal Cancer: Surgical Treatment of Esophageal Cancer – long term outcomes Background The therapeutic value of extended lymphadenectomy in esophageal cancer remains unresolved. While 2-field lymph node dissection (2FLND) is standard, prophylactic 3-field lymphadenectomy (3FLND) is practiced selectively despite limited high-level evidence. We conducted a large randomized trial to determine whether radical 3FLND confers a survival advantage over standard 2FLND. Methods In this randomized controlled trial (ClinicalTrials.gov NCT00193817), patients aged 18–75 years with operable esophageal cancer and no clinicoradiological supracarinal nodal disease were randomized intraoperatively to 2FLND or 3FLND with allocation concealment. Stratification factors included histology, tumor stage, location, and neoadjuvant therapy. The 2FLND arm included infracarinal mediastinal and D2 abdominal dissection; the 3FLND arm additionally included bilateral supracarinal mediastinal and lower cervical lymphadenectomy. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS) and major postoperative complications. Patients were followed up for clinical, radiological or cyto/pathological evidence of recurrence. Analyses were by intention-to-treat; we used Kaplan-Meier curves and log-rank test to compare OS and DFS, and chi-square test for postoperative complications. Results A total of 700 patients were randomized (2FLND: n=359; 3FLND: n=341) with well-balanced baseline characteristics (Table). 3FLND yielded significantly higher nodal counts (median 38 vs 23) and required longer median operative time (6 vs 5.15 hours) and hospital stay (14.5 vs 12 days). Median intraoperative blood loss (500 ml vs 500 ml) and ICU stay (1 vs 1 day) were similar in the two arms. At a median follow-up of 124 months, 3FLND did not improve survival outcomes. Five-year OS was 57% for 3FLND versus 53% for 2FLND (HR 0.97; 95% CI 0.79–1.20; p=0.78), with median OS of 113 vs 90 months, respectively. Five-year DFS was similarly comparable (54% vs 50%; HR 0.93; 95% CI 0.76–1.15; p=0.51) with median DFS of 109 vs 60 months, respectively. Major postoperative complications were similar with 3FLND and 2FLND (19.4% vs 14.8%, OR 1.38; 95% CI 0.93–2.0; p=0.13). Conclusion In the largest randomized trial addressing this question, prophylactic radical 3-field lymphadenectomy did not improve overall or disease-free survival compared with standard 2-field dissection, despite substantially higher nodal yield. These findings do not support routine use of 3FLND in operable esophageal cancer and reinforce 2FLND as the standard of care.