According to the American Urologic Association (AUA) guidelines clinicians should remove at minimum nodes from the external and internal iliac and obturator areas with a minimum of 10-12 nodes. The European Association of Urology (EAU) states that PLND results in a better oncologic outcome compared with no PLND. No difference between extended and superextended PLND has been shown, but they provide better results compared to a limited or standard PLND. However, the quality of data behind these recommendations are of poor quality and thus no firm conclusion can be drawn. Thus, data from ongoing randomized trials on the therapeutic effect of the extend of PLND are needed.
The Limited versus extended PLND (up to the inferior mesenteric artery) trial in BC patients undergoing radical cystectomy (the LEA trial, AUO AB 25/02 NCT01215071) is a prospective randomized trial that attempted to asses which PLND template is better. In this trial, all patients with cT1-T4a BC patients were eligible. No neoadjuvant chemotherapy was allowed. Overall 433 patients were randomized with a dropout rate of 16.4%. The primary endpoint was recurrence free survival (RFS) at 5 years. The trial had a power of 90% with an effect size of 15% and a hazard ratio of 0.8 (final result). Patients who were Pt3-Pt4a and or PN+ were offered adjuvant chemotherapy in both arms.
The results of this trial showed that 50.1% of patients were <=Pt2N0 and 23.9% and lymph node (LN) involvement. Out of the 183 patients who received an extended PLND, 61.1% of the involved LN were located in the limited template, while 38.9% were located outside of it. Five year RFS was 61.5% in the limited arm vs. 67% in the extended arm, log rank p=0.34 (HR 0.83, 95% CI 0.56-1.22). The median RFS was not reached in both arms (Figure 1). There were no differences in the complication rate except in the rate of lymphocele requiring intervention (3.7% in the limited arm vs. 9.3% in the extended arm, p=0.03).
In summary, although the LEA trial demonstrated a trend of improved RFS at 5 years in favor of extended PLND, a significant difference could not be demonstrating favoring one template over the other. Additional data from phase 3 trials, such as the American SWOG 1011 trial are awaited to demonstrate if a benefit exists.
Figure 1 – Recurrence Free Survival:
Speaker: Richard.E. Hautmann, MD, Professor hon University of Ulm Boschstrasse, Neu-Ulm, Germany
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at The 15th Meeting of the EAU Section of Oncological Urology ESOU18 - January 26-28, 2018 - Amsterdam, The Netherlands