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

Area of Science:

• Urology
• Surgical Oncology
• Oncology

Background:

• Lymph node dissection (LND) extent during radical cystectomy (RC) for bladder cancer (BC) may impact oncologic outcomes.
• High-risk T1 grade 3 or muscle-invasive urothelial BC (T2-T4a M0) requires careful surgical management.

Purpose of the Study:

• To evaluate the long-term oncologic outcomes of standard versus extended lymph node dissection (LND) in patients undergoing radical cystectomy (RC) for bladder cancer (BC).
• To compare recurrence-free survival (RFS), overall survival (OS), and cancer-specific survival (CSS) between standard LND (sLND) and extended LND (eLND) in a phase 3 trial.

Main Methods:

• A prospective, multicenter, phase 3 randomized controlled trial (NCT01215071) involving 401 patients with locally resectable, high-risk urothelial BC.
• Patients were randomly assigned 1:1 to either sLND or eLND.
• Median follow-up was 58.4 months for patients alive without recurrence.

Main Results:

• Extended LND (eLND) did not demonstrate superiority over standard LND (sLND) for recurrence-free survival (5-yr RFS: 68% vs 60%; HR 0.80, p=0.2) or overall survival (5-yr OS: 57% vs 51%; HR 0.84, p=0.2).
• Cancer-specific survival (CSS) was significantly higher in the eLND arm (5-yr CSS: 76% vs 65%; HR 0.65, p=0.031), indicating a clinically meaningful benefit.
• The trial was negative for the primary endpoint of RFS but positive for CSS.

Conclusions:

• While extended LND did not improve RFS or OS in this trial, the significant improvement in CSS suggests a potential benefit for patients undergoing radical cystectomy for bladder cancer.
• Meticulous lymph node dissection, at least using a standard template, remains the recommended surgical approach for patients undergoing RC for BC.
• Long-term follow-up confirms the importance of thorough nodal assessment in bladder cancer management.