medwireNews: Extended lymphadenectomy does not improve the outcomes of people with localized muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy compared with standard lymphadenectomy, indicate phase 3 findings.
Furthermore, the extended procedure “was associated with higher perioperative morbidity and mortality,” note the researchers in The New England Journal of Medicine, which further supports standard over extended lymphadenectomy.
They explain that “[d]espite a lack of data from randomized trials to confirm a benefit with more extensive lymphadenectomy, many academic centers have adopted this approach,” and the team therefore conducted the SWOG S1011 trial to address this research question.
The study enrolled 592 patients from 27 sites in the USA and Canada who had disease of clinical stage T2–T4a with two or fewer positive nodes (N0–N2), and who had elected to undergo radical cystectomy with curative intent.
The participants were randomly assigned during surgery “to undergo bilateral standard lymphadenectomy (dissection of lymph nodes on both sides of the pelvis) or extended lymphadenectomy involving removal of common iliac, presciatic, and presacral nodes,” write Seth Lerner (Baylor College of Medicine Medical Center, Houston, Texas, USA) and colleagues.
The median age of the participants was 68–69 years and 78–81% were men. Over half (57%) of patients in each group received neoadjuvant chemotherapy, most commonly (86–89%) cisplatin-based regimens. A median of 39 nodes were removed in the extended lymphadenectomy group and 24 in the standard lymphadenectomy group.
After a median follow-up of 6.1 years, the estimated 5-year rates of disease-free survival did not differ significantly between the extended and standard lymphadenectomy arms, at 56% and 60%, respectively, and a nonsignificant hazard ratio (HR) for recurrence or death of 1.10.
The overall survival rates at 5 years were similarly comparable, at 59% with extended lymphadenectomy and 63% with standard lymphadenectomy, and a nonsignificant HR for death of 1.13.
Adverse events of at least grade 3 occurred in 54% of patients who underwent extended lymphadenectomy and 44% of those who had standard lymphadenectomy. The most frequent event of this severity was anemia, occurring in a respective 15% and 18% of patients, followed by urinary tract infection (9 vs 9%), sepsis (7 vs 5%), and wound complications (5 vs 4%).
There were eight (3%) deaths within 30 days of surgery in the extended lymphadenectomy group and one (<1%) in the standard lymphadenectomy group. Within 90 days of surgery there were 19 (7%) and seven (2%) deaths, respectively.
Lerner and associates point out that most of the deaths within 90 days were due to postoperative complications, with the exception of five deaths in the extended lymphadenectomy group and two in the standard lymphadenectomy group, which were due to disease progression.
Discussing the findings, the investigators say that “[i]t is possible that extended lymphadenectomy has a benefit without neoadjuvant chemotherapy, but we did not observe heterogeneity in results in a post hoc analysis according to receipt of neoadjuvant chemotherapy.”
Furthermore, the previous LEA trial of extended versus standard bilateral pelvic lymphadenectomy, “which did not allow the use of neoadjuvant chemotherapy, also did not show a benefit with extended lymphadenectomy,” they conclude.
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N Engl J Med 2024; 391: 1206–1216
