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1. In this randomized controlled trial, extended lymphadenectomy did not improve disease-free or overall survival in patients with muscle-invasive bladder cancer who were undergoing a radical cystectomy.

2. Extended lymphadenectomy was associated with higher perioperative morbidity and mortality in patients undergoing a radical cystectomy for muscle-invasive bladder cancer.

Evidence Rating Level: 1 (Excellent)

Study Rundown: The dissection of pelvic lymph nodes, termed bilateral pelvic lymphadenectomy, is a vital component of radical cystectomy surgery in individuals with bladder cancer. Lymphadenectomies help with local cancer control and identifying nodal metastases and are associated with long-term disease-free survival in patients with nodal metastases. Despite a lack of randomized controlled trials assessing their efficacy, extended lymphadenectomies have become the standard of care in many high-volume centers. Randomized controlled trials assessing extended lymphadenectomy in other cancer surgeries have not shown improvements in survival outcomes. This presents concern for potential morbidity and mortality that outweighs the oncologic benefit. The present trial compared disease-free survival in patients with muscle-invasive bladder cancer who underwent a radical cystectomy with either standard or extended pelvic lymphadenectomy. Compared to the standard pelvic lymphadenectomy group, patients in the extended lymphadenectomy group did not have improved disease-free or overall survival. Instead, the extended lymphadenectomy group was associated with high perioperative morbidity and mortality at 90 days. This study’s generalizability was limited, given that it only applies to patients with predominant urothelial histological features and clinical stage T2 to T4a disease with ≤2 positive nodes. Overall, the findings from this trial indicate that extended pelvic lymphadenectomy does not confer survival benefits and may even be more harmful than standard pelvic lymphadenectomy in patients with muscle-invasive bladder cancer.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This phase three randomized controlled trial assessed whether extended pelvic lymphadenectomy was associated with improved disease-free and overall survival compared to standard lymphadenectomy in patients with muscle-invasive bladder cancer who underwent radical cystectomy. Patients with urothelial cancer of clinical stage T2 to T4a with two or fewer positive nodes who had elected to undergo radical cystectomy with curative intent were eligible for this trial. Patients who had undergone previous partial cystectomy or pelvic surgery with complete extended lymphadenectomy or were deemed inappropriate for the indicated surgery were excluded from this trial. A total of 592 patients were randomly assigned in a 1:1 ratio to undergo either extended lymphadenectomy (n=292) or standard lymphadenectomy (n=300) across sites in the United States and Canada. The primary outcome was disease-free survival, as defined by the first documentation of relapse or recurrence or all-cause death after randomization. By the median follow-up of 6.1 years, 130 (45%) individuals in the extended lymphadenectomy group and 127 (42%) in the standard lymphadenectomy had disease recurrence or death. The five-year disease-free survival was 56% for the extended lymphadenectomy group and 60% for the standard lymphadenectomy group (hazard ratio for recurrence or death, 1.10; 95% Confidence Interval [CI], 0.86 to 1.40; p = 0.45). The five-year survival was 59% in the extended lymphadenectomy group and 63% in the standard lymphadenectomy group (hazard ratio for death, 1.13; 95% CI, 0.88 to 1.45). Overall, this phase three randomized controlled trial revealed that extended pelvic lymphadenectomy does not improve disease-free and overall survival rates in patients with muscle-invasive bladder cancer who are undergoing a radical cystectomy.

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