A RECENT subgroup analysis of the Phase III SWOG S1011 trial has provided crucial insights into the efficacy and safety of extended lymph node dissection (ELND), during radical cystectomy for muscle-invasive urothelial cancer. Presented during the 2024 American Urological Association (AUA) Annual Meeting, the findings challenge the perceived benefits of ELND, highlighting its lack of additional overall survival (OS) or disease-free survival (DFS) benefit compared to standard lymph node dissection (SLND).
Lead author Seth P. Lerner, Baylor College of Medicine, Houston, Texas, USA, emphasised significant concerns regarding mortality rates, with the ELND arm showing substantially higher mortality events at both 30 and 90 days compared to the SLND arm. Despite removing progressed patients from the analysis, the mortality disparity persisted. Additionally, patients who underwent ELND experienced greater morbidity, perioperative mortality, longer surgical times, increased blood loss, and higher rates of venous thromboembolism compared to SLND recipients.
In the SWOG S1011 trial, patients underwent random assignment to either ELND (n=292 intent-to-treat; total: 303) or SLND (n=300 intent-to-treat; total: 315) after intraoperative exploration. ELND involved the removal of lymph nodes up to the aortic bifurcation, while SLND was limited to pelvic nodes. The study revealed similar rates of pathologically proven pelvic lymph node metastasis between both arms.
Notably, ELND was associated with a higher incidence of Grade 3, 4, and 5 adverse events, including sepsis, wound complications, ileus, and thromboembolic events. Although variant histology had no impact on DFS or OS rates, patients with ileal conduit experienced worse outcomes, likely due to more advanced disease.
Despite a higher lymph node yield in patients with ELND, the study found no indication of improved DFS or OS with long-term follow-up. Furthermore, ELND was linked to increased local recurrence rates compared to SLND, emphasising the need for cautious patient communication regarding treatment risks and benefits.
Reference
Lerner SP et al. Paradigm-shifting clinical trials in urology: SWOG S1011 – subgroup analysis of the phase iii surgical trial to evaluate the benefit of a standard versus an extended lymphadenectomy performed at time of radical cystectomy for MIBC. Abstract 70549953. AUA Annual Meeting, 3-6 May, 2024.
