Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial

The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.

To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).

Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).

Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).

The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.

In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.

Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).

In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range.

European urology. 2018 Oct 15 [Epub ahead of print]

Jürgen E Gschwend, Matthias M Heck, Jan Lehmann, Herbert Rübben, Peter Albers, Johannes M Wolff, Detlef Frohneberg, Patrick de Geeter, Axel Heidenreich, Tilman Kälble, Michael Stöckle, Thomas Schnöller, Arnulf Stenzl, Markus Müller, Michael Truss, Stephan Roth, Uwe-Bernd Liehr, Joachim Leißner, Thomas Bregenzer, Margitta Retz

Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany. Electronic address: ., Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany., AUO Study Group, Germany., Department of Urology, University of Essen, Germany., Department of Urology, Heinrich Heine University, Düsseldorf, Germany., Department of Urology, Paracelsus Hospital Golzheim Düsseldorf, Düsseldorf, Germany., Department of Urology, Hospital of Karlsruhe, Germany., Department of Urology, Hospital of Kassel, Germany., Department of Urology, University of Cologne, Cologne, Germany., Department of Urology, Hospital of Fulda, Germany., Department of Urology, Saarland University Medical Center, Homburg, Germany., Department of Urology, Ulm University, Germany., Department of Urology, Eberhard Karls University, Tübingen, Germany., Department of Urology, Hospital Ludwigshafen, Germany., Department of Urology, Hospital Dortmund, Germany., Department of Urology, Helios Hospital, Wuppertal, Germany., Department of Urology, Otto von Guericke University, Magdeburg, Germany., Department of Urology, Hospital Holweide, Cologne, Germany.

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