Long-term Results from the LEA Randomized Trial: Extended Versus Standard Lymph Node Dissection in Patients with Bladder Cancer Undergoing Radical Cystectomy.

Abstract

The extent of lymph node dissection (LND) at the time of radical cystectomy (RC) for bladder cancer (BC) may affect oncologic outcomes. We present updated long-term data from a prospective, multicenter, phase 3 trial involving patients with locally resectable, high-risk T1 grade 3 or muscle-invasive urothelial BC (T2-T4a M0) without neoadjuvant treatment (trial LEA AUO AB 25/02; NCT01215071). A total of 401 patients were randomly assigned 1:1 to either standard LND (sLND: obturator, internal, and external iliac nodes) or extended LND (eLND), which also included the deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortic nodes up to the inferior mesenteric artery. Median follow-up for patients alive without disease recurrence was 58.4 mo. The primary endpoint was recurrence-free survival (RFS). Overall survival (OS) and cancer-specific survival (CSS) were secondary endpoints. eLND failed to show superiority over sLND for RFS (5-yr rate: 68% vs 60%; hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.56-1.14; p = 0.2) and OS (5-yr rate: 57% vs 51%; HR 0.84, 95% CI 0.64-1.12; p = 0.2). The CSS rate was significantly higher in the eLND arm (5-yr rate: 76% vs 65%; HR 0.65, 95% CI 0.43-0.96; p = 0.031), which is clinically meaningful. With long-term follow-up, this randomized controlled trial remains negative for the primary endpoint of RFS, but was positive for CSS. Therefore, meticulous LND using at least a standard template remains the recommended surgical approach for patients undergoing RC for BC.