As reported in The New England Journal of Medicine by Lerner et al, the phase III SWOG S1011 trial showed no disease-free survival benefit for extended vs standard lymphadenectomy in patients with muscle-invasive bladder cancer undergoing radical cystectomy.
Study Details
In the trial, 592 patients with localized disease from sites in the United States and Canada were randomly assigned during surgery between August 2011 and February 2017 to undergo bilateral standard lymphadenectomy (dissection of nodes on both sides of the pelvis; n = 300) or extended lymphadenectomy involving removal of common iliac, presciatic, and presacral nodes (n = 292).
A total of 57% of patients in each group had received neoadjuvant chemotherapy. The primary outcome measure was disease-free survival.
Disease-Free Survival
Median follow-up was 6.1 years. At 5 years, the disease-free survival rate was 56% with extended lymphadenectomy vs 60% with standard lymphadenectomy (hazard ratio [HR] = 1.10, 95% confidence interval [CI] = 0.86–1.40, P = 0.45). At 5 years, the overall survival rate was 59% with extended lymphadenectomy vs 63% with standard lymphadenectomy (HR = 1.13, 95% CI = 0.88–1.45).
Adverse Events
Grade ≥ 3 adverse events were reported in 54% of patients who underwent extended lymphadenectomy vs 44% of patients who underwent standard lymphadenectomy. The most common adverse events in both groups were anemia (15% vs 18%), urinary tract infection (9% vs 9%), and sepsis (7% vs 5%). Death within 90 days after surgery occurred in 19 patients (7%) in the extended lymphadenectomy group and 7 patients (2%) in the standard lymphadenectomy group.
The investigators concluded: “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.”
Seth P. Lerner, MD, of the Scott Department of Urology, Baylor College of Medicine, Houston, is the corresponding author of The New England Journal of Medicine article.
Disclosure: The study was funded by the National Cancer Institute and Canadian Cancer Society. For full disclosure information of the study authors, visit nejm.org.
