For this study, patients with D'Amico intermediate or high risk prostate cancer, absence of bone metastasis, and no previous treatment were randomized to undergo extended or limited PLND (1:1) during radical prostatectomy. Limited PLND (lPLND) included the obturator chain bilaterally, and ePLND involved bilaterally chains including obturator, external-, internal-, common-iliac and pre-sacral nodes. The primary endpoint was biochemical recurrence-free survival (BRFS), analyzed in the intention-to-treat population.
From May 2012 to August 2016, 291 patients were randomized as outlined (n=145 – ePLND; n=146 – lPLND), with comparable baseline characteristics between the two groups. The sample size calculated was 260 patients and the trial was designed with 80% power and an alpha error rate of 0.05 to detect a 10% difference in 5-year biochemical recurrence-free survival rate in favor of the ePLND group (HR 0.78 vs 0.67). Over a median follow-up of 35.2 months, ePLND significantly increased operative time, estimated blood loss, length of hospital stay, and postoperative complications. There were 59% and 62% rates of stage ≥ pT3a disease for ePLND and lPLND groups, respectively. ePLND and lPLND yielded median (mean) 17 (19.8) and 3 (4.1) nodes, respectively (p < 0.001). ePLND resulted in 6.3 times more lymph node metastases (p < 0.001), however there was no difference in biochemical recurrence (PSA ≥ 0.2 ng/mL; p=0.4), receipt of radiotherapy, ADT, bone metastases or death. The strength of this study is the investigator’s ability to perform this surgical RCT.
The authors concluded that ePLND in intermediate- and high-risk prostate cancer patients is associated with better staging, increased morbidity and no oncological benefit with initial short follow-up. Whether longer follow-up results in significantly improved downstream endpoints is doubtful, but remains to be seen.
Clinical trial: NCT01812902
Presented By: Jean Felipe Prodocimo Lestingi, Sao Paulo State Cancer Institute – University of Sao Paulo, Sao Paulo, Brazil
Co-Authors: Giuliano Guglielmetti, Jose Pontes Jr, Anuar Ibrahim Mitre, Alvaro Sarkis, Diogo Assed Bastos, Rachel Riechelmann, Romulo Loss Mattedi, Mauricio Cordeiro, Rafael Coelho, Miguel Srougi, William Carlos Nahas
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA