Extended Lymphadenectomy fails to Improve Survival in Muscle-Invasive Bladder Cancer Patients: NEJM

A recent study published in the New England Journal of Medicine and found no significant survival benefit of extended lymphadenectomy over standard lymphadenectomy in patients with localized muscle-invasive bladder cancer undergoing radical cystectomy. The randomized trial enrolled a total of 658 patients to compare the outcomes of extended lymphadenectomy, involving the removal of additional lymph nodes with standard lymphadenectomy and to focus on survival and safety outcomes.

The trial included patients with clinical stage T2 to T4a bladder cancer (cancer confined to muscle or invading adjacent organs) and up to 2 positive lymph nodes. They were randomly assigned to either undergo standard lymph node dissection (involving pelvic nodes) or extended lymphadenectomy (removal of common iliac, presciatic, and presacral nodes). The primary focus was disease-free survival, with overall survival and safety being secondary outcomes.

The results of this study showed no significant improvement in disease-free or overall survival for patients who underwent extended lymphadenectomy at a median follow-up of 6.1 years. Also, recurrence or death occurred in 45% of patients in the extended group and 42% in the standard group. The estimated 5-year disease-free survival was 56% in the extended-lymphadenectomy group and 60% in the standard group, yielding a hazard ratio for recurrence or death of 1.10 (95% CI, 0.86–1.40; P=0.45). The overall survival at 5 years was 59% for the extended group and 63% for the standard group, with a hazard ratio for death of 1.13 (95% CI, 0.88–1.45).

In terms of safety, adverse events were more common in the extended-lymphadenectomy group, where 54% of patients experienced grade 3 to 5 complications when compared to 44% in the standard-lymphadenectomy group. Post-operative mortality within 90 days was also higher in the extended group where 7% of patients succumbed to complications than the 2% in the standard group.

The findings suggest that extended lymphadenectomy does not offer a significant survival advantage over the standard approach and comes with increased risks of perioperative complications. Further research may be needed to refine surgical guidelines and identify subgroups of patients who may benefit from extended procedures.

Reference:

Lerner, S. P., Tangen, C., Svatek, R. S., Daneshmand, S., Pohar, K. S., Skinner, E., Schuckman, A., Sagalowsky, A. I., Smith, N. D., Kamat, A. M., Kassouf, W., Plets, M., Bangs, R., Koppie, T. M., Alva, A., La Rosa, F. G., Pal, S. K., Kibel, A. S., Canter, D. J., & Thompson, I. M., Jr. (2024). Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. In New England Journal of Medicine (Vol. 391, Issue 13, pp. 1206–1216). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2401497