Extended lymphadenectomy does not improve bladder cancer outcomes, increases morbidity
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Key takeaways:
- Extended lymphadenectomy did not improve outcomes in localized muscle-invasive bladder cancer vs. standard lymphadenectomy.
- Patients who received standard lymphadenectomy had fewer serious adverse events.
Extended lymphadenectomy offered no survival benefit for patients with localized muscle-invasive bladder cancer compared with bilateral standard lymphadenectomy for patients undergoing radical cystectomy, according to study findings.
Results of the randomized phase 3 SWOG S1011 trial showed higher perioperative morbidity and mortality among those who underwent extended lymphadenectomy.
Investigators anticipate the results will establish bilateral standard lymphadenectomy as the standard of care for this population.
“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 SWOG S1011 trial and Beth and Dave Swalm chair in urologic oncology at Baylor College of Medicine, said in a press release. “Prior to S1011, however, most academic centers had adopted a more extensive lymphadenectomy.”
Results of S1011 — along with findings from the previously reported LEA trial — help to address “a highly relevant surgical question testing whether there is an oncologic benefit to extended lymphadenectomy,” Lerner said.
Lerner and colleagues conducted SWOG S1011 to assess if extended lymphadenectomy would confer DFS or OS benefits vs. standard lymphadenectomy for patients with localized muscle-invasive bladder cancer undergoing radical cystectomy.
The trial included 592 patients with clinical stage T2 to T4a disease who had two or fewer positive nodes.
Researchers randomly assigned patients to bilateral standard lymphadenectomy (n = 300) or extended lymphadenectomy (n = 292).
Investigators stratified by receipt and type of neoadjuvant chemotherapy, tumor stage and Zubrod’s performance score.
DFS served as the primary outcome. Researchers also evaluated OS and safety.
Thirty-six surgeons from 27 sites in the U.S. and Canada performed the surgeries, and more than half (57%) of patients received neoadjuvant chemotherapy.
Median follow-up was 6.1 years.
A comparable percentage of patients in the extended lymphadenectomy and standard lymphadenectomy cohorts developed recurrence or died (45% vs. 42%). Estimated 5-year Results showed no statistically significant differences between the extended and standard groups with regard to 5-year DFS (56% vs. 60%; HR = 1.1; 95% CI, 0.86-1.4) or 5-year OS (59% vs. 63%; HR = 1.13; 95% CI, 0.88-1.45).
A higher percentage of patients assigned extended lymphadenectomy developed grade 3 to grade 5 adverse events (54% vs. 44%). More patients assigned extended lymphadenectomy died within 90 days of surgery (6.5% vs. 2.3%).
References:
- In surgery for localized muscle-invasive bladder cancer, extended lymph node removal offers no survival benefit but does increase morbidity (press release). Available at: https://www.swog.org/news-events/news/2024/10/02/s1011-standard-lymphadenectomy-not-extended. Published Oct. 2, 2024. Accessed Oct. 3, 2024.
- Lerner SP, et al. N Engl J Med. 2024;doi: 10.1056/NEJMoa2401497.
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