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Extended Lymphadenectomy Fails to Improve Survival Outcomes for Patients With Muscle-Invasive Bladder Cancer
Results from the phase 2 SWOG S1011 study demonstrated that extended lymphadenectomy failed to improve survival compared to standard lymphadenectomy among patients with localized muscle-invasive bladder cancer.
According to Seth Lerner, MD, Baylor College of Medicine Medical Center, Houston, Texas, and coauthors, “Whether extended lymphadenectomy is associated with improved disease-free and overall survival, as compared with standard lymphadenectomy, among patients with localized muscle-invasive bladder cancer undergoing radical cystectomy is unclear.”
This multicenter study enrolled 592 patients with stage T2 to T4a localized muscle-invasive bladder cancer who had ≤ 2 positive lymph nodes. Patients were randomized on a 1-to-1 basis to undergo either bilateral standard lymphadenectomy (n = 300) or extended lymphadenectomy (n = 292). The primary end point was 5-year disease-free survival (DFS). Key secondary end points included 5-year overall survival (OS) and safety.
At a median follow-up of 6.1 years, recurrence or death occurred in 42% of patients in the standard arm and 45% of patients in the extended arm. The estimated 5-year DFS rate was 60% in the standard arm and 56% in the extended arm (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.86 to 1.40; P = .45). The estimated 5-year OS rate was 63% and 59%, respectively (HR, 1.13; 95% CI, 0.88 to 1.45). Grade ≥ 3 adverse events occurred in 44% of patients in the standard arm and 54% of patients in the extended arm. Within 90 days of surgery, death occurred in 2% of patients in the standard arm and 7% of patients in the extended arm.
“As compared with standard lymphadenectomy, extended lymphadenectomy did not result in improved disease-free or overall survival among patients with muscle-invasive bladder cancer undergoing radical cystectomy and was associated with higher perioperative morbidity and mortality,” concluded Dr Lerner et al.
Source:
Lerner SP, Tangen C, Svatek RS, et al. Standard or extended lymphadenectomy for muscle-invasive bladder cancer. N Engl J Med. Published online: October 2, 2024. doi: 10.1056/NEJMoa2401497