A Phase III clinical trial published in the New England Journal of Medicine has shown that performing an extended lymph node removal during surgery for muscle-invasive bladder cancer does not lead to improved survival compared to the standard lymphadenectomy. The SWOG S1011 trial, which enrolled 618 patients, found that while extended lymphadenectomy did not enhance survival outcomes, it did increase the likelihood of surgical complications and mortality in the immediate postoperative period.
The SWOG S1011 trial set out to determine whether removing a larger number of lymph nodes during radical cystectomy would lead to better survival outcomes in patients with muscle-invasive bladder cancer. Patients were randomly assigned to receive either a standard lymphadenectomy or an extended procedure, which involved removing additional lymph nodes extending up to the aortic bifurcation. After more than six years of follow-up, researchers found that there were no significant improvements in either disease-free or overall survival between the two groups.
Specifically, those who underwent the standard procedure had a five-year disease-free survival rate of 60%, compared to 56% for the extended group. Overall survival at five years was 63% for the standard group and 59% for the extended group. These differences were not statistically meaningful, indicating that more extensive lymph node removal did not confer a survival advantage.
However, patients in the extended lymphadenectomy group faced higher risks of serious complications. More patients in the extended group experienced grade 3 to 5 adverse events—54% compared to 44% in the standard group. Additionally, the rate of death within 90 days of surgery was higher in the extended group, with 6.5% of these patients dying compared to 2.3% in the standard group.
These findings are important as they challenge the prevailing assumption that more extensive surgical procedures improve cancer control. Prior to this trial, many surgical centers had begun to favor extended lymph node removal during radical cystectomy based on earlier studies. The results of this trial, alongside similar findings in other cancer types, suggest that caution is warranted before adopting more aggressive surgical techniques.
For clinicians treating bladder cancer, this study emphasizes the need for evidence-based surgical approaches. The increased risk of complications and mortality linked to extended lymphadenectomy suggests that a more conservative surgical approach may offer similar survival outcomes while enhancing patient safety. These results are expected to shape future treatment guidelines, likely favoring standard lymphadenectomy as the preferred approach for muscle-invasive bladder cancer.