The SWOG S1011 randomized phase 3 trial found no significant improvement in disease-free or overall survival but a higher rate of grade 3-4 adverse events and an increased risk of death in the 90 days after surgery. The findings, published in NEJM, should establish a standard bilateral pelvic lymphadenectomy that includes the external and internal iliac and obturator nodes as the standard of care for these patients. Final results from the SWOG S1011 randomized phase 3 clinical trial, just published in the New England Journal of Medicine , indicate patients undergoing surgery for localized muscle-invasive bladder cancer derive no significant survival benefit from having an extended lymph node removal (extended lymphadenectomy) rather than the standard lymphadenectomy.
The extended lymphadenectomy also increased the risk of complications and death in the three months following surgery. Bilateral pelvic lymphadenectomy is an essential component of radical cystectomy as it provides local control, accurately identifies pathologic nodal metastases, and is associated with long-term disease-free survival for some patients with proven nodal metastases." Seth P.
Lerner, MD, principal investigator on the S1011 trial and the Beth and Dave Swalm Chair in Urologic Oncology at Baylor College of Medicine "Prior to S1011, however, most academic centers had adopted a more extensive lymphadenectomy based on seminal work by Don Skinner and others. Together with the German LEA trial led by Juerge.
