Guru P. Sonpavde, MD, discusses results from the phase 3 SWOG S1011 trial conducted in patients with muscle-invasive bladder cancer.
Guru P. Sonpavde, MD, medical director, Genitourinary (GU) Oncology, assistant director, the Clinical Research Unit, the Christopher K. Glanz Chair, Bladder Cancer Research, AdventHealth Cancer Institute, discusses results from the phase 3 SWOG S1011 trial (NCT01224665) conducted in patients with muscle-invasive bladder cancer (MIBC).
Data presented at the 2023 ASCO Annual Meeting showed that at the time of radical cystectomy, extended pelvic lymph node lymphadenectomy (ELND) did not significantly improve disease-free survival (DFS) or overall survival vs standard SLND in patients with MIBC. Specifically, in all eligible randomized patients, the hazard ratio (HR) for DFS was 1.10 (95% CI, 0.87-1.42; 2-sided P = .40) and the HR for OS was 1.15 (95% CI, 0.89-1.48; 2-sided P = .29).
For the phase 3 surgical study, investigators sought to compare outcomes of patients undergoing radical cystectomy for their disease who were treated with radical cystectomy and a SLND (n = 300) and an ELND (n = 292) beyond the pelvis, up to the bifurcation of the aorta, Sonpavde explains. Patients were enrolled between August 2011 and March 2017, and the median follow-up in both arms was 6.1 years.
The primary objective of the study was DFS, and key secondary objectives included OS; operative time; post-operative morbidity, defined as from surgery to 90 days after the procedure; length of hospital stay; lymph node counts and lymph node density; and receipt of adjuvant chemotherapy.
Notably, an increase in toxicities and post-operative complications was observed with ELND vs SLND, according to Sonpavde. The 30-day mortality rates with SLND and ELND were 0.3% and 2.7%, respectively; the 90-day mortality rates were 2.4% and 6.5%, respectively.
Data from this study could be practice changing, according to Sonpavde, as they suggest that SLND is adequate and should be standard of care for patients with cT2-4a/N0-2 urothelial cancer.