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Extended versus limited pelvic lymphadenectomy during radical prostatectomy for intermediate- and high-risk prostate cancer: Early outcomes from a randomized controlled phase III study
Jean Felipe Prodocimo Lestingi, Giuliano Guglielmetti, Jose Pontes Jr, Anuar Ibrahim Mitre, Alvaro Sarkis, Diogo Assed Bastos, et al.
Editorial comment from Prof. Piotr Chlosta:
Early results of randomized controlled trial comparing extended and limited pelvic lymph node dissection (ePLND) in intermediate and high risk prostate cancer showed no oncological benefits of ePLND with initial short follow-up. Long-term results are awaited.
The role of extended pelvic lymph node dissection (ePLND) in treating prostate cancer (PCa) patients remains controversial, mainly by the lack of RCTs.
Patients with D'Amico intermediate or high risk PCa, absence of bone metastasis and no previous treatment were prospectively computer randomised to undergo extended or limited PLND (1:1) during radical prostatectomy. Limited PLND (lPLND) included the obturator chain bilaterally; ePLND involved bilaterally chains: obturator, external-, internal-, common-iliac and pre-sacral. Surgical specimens and each chain were analyzed separately, according to College of American Pathologists. All patients signed a free and informed consent and local ethics committee approved the study. The primary endpoint was biochemical recurrence-free survival, analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01812902.
Since May 2012 until August 2016, 291 patients were randomly assigned, 145 to ePLND and 146 to lPLND. Preoperative data were comparable between groups. Median follow-up was 35.2 months. EPLND increased significantly operative time (54 minutes), estimated blood loss (100 mL), length of hospital stays (1 day) [p≤0.001], transfusion rate [p = 0.05] and postoperative complications according to Clavien scale [p = 0.03]. There was no difference in Pathologic Gleason grade, T stage or positive surgical margin. On ePLND and lPLND groups, 59.3% and 61.7% were staged ≥ pT3a, respectively. EPLND and lPLND yielded median (mean) 17 (19.8) and 3 (4.1) nodes, respectively (p < 0.001). EPLND showed 6.3 times more lymph node metastases (p < 0.001) and only it was able to show positive nodes in intermediate risk. There were no difference in biochemical recurrence (PSA ≥ 0.2 ng/mL) using Kaplan-Meyer method (p = 0.4), Radiotherapy, Androgen Deprivation Therapy, bone metastases or death.
Extended lymphadenectomy in intermediate- and high-risk prostate cancer patients is associated with better tumor staging, increased morbidity and no oncological benefits in this initial short follow-up time. Clinical trial information: NCT01812902
© 2017 American Society of Clinical Oncology (ASCO).