Updated trial refines role of extended lymph node dissection
More than 10 years of follow-up reveal improved outcomes with EPLND in patients with ISUP grade 3-5 prostate cancer.
The removal of pelvic lymph nodes is commonly performed during radical prostatectomy for prostate cancer. However, the use of extended pelvic lymph node dissection (EPLND) is controversial.
A phase 3 randomized trial evaluating EPLND versus limited pelvic lymph node dissection (LPLND) during radical prostatectomy for intermediate- and high-risk prostate cancer was published in 2021. During Friday’s Practice-Changing, Paradigm-Shifting Clinical Trials in Urology session, Jean F.P. Lestingi, MD, PhD, assistant professor of urology at the Instituto de Cancer do Estado de Sao Paulo, presented updated data.
The trial enrolled 300 patients, randomized to EPLND (obturator, external iliac, internal iliac, common iliac and presacral nodes) or LPLND (obturator nodes). The primary endpoint was biochemical recurrence-free survival (BCRFS), and secondary endpoints included metastasis-free survival (MFS) and cancer-specific survival (CSS).
“As previously published, this randomized phase 3 trial did not demonstrate oncologic superiority of EPLND over LPLND among unselected intermediate and high-risk prostate cancer patients,” Dr. Lestingi said.
According to guidelines, clinicians should inform patients that pelvic lymph node dissection can provide staging information but does not have consistently documented improvement in MFS, CSS or overall survival. However, recent research has suggested otherwise: One study reported a better MFS among patients randomized to EPLND, although there was still no statistically significant difference in BCRFS.
Dr. Lestingi and team continued to follow the patients in this phase 3 trial. At a median of 130.6 months, patients with biopsy International Society of Urological Pathology (ISUP) group grade 3-5 demonstrated a significant and sustainable benefit in BCRFS.
The study also looked at secondary treatments needed. In the ISUP biopsy grade 3-5 subset, the median time to radiotherapy was 43.7 months in the LPLND group and was not reached in the EPLND group. The median time to androgen deprivation therapy was 66.5 months in the LPLND group and was not reached in the EPLND group. These results suggest that the benefits seen for the more aggressive cancer type came from the surgical approach.
Based on these findings, Dr. Lestingi suggests that EPLND could be considered the standard of care in ISUP grade 3-5 patients undergoing radical prostatectomy. He also emphasized the need for guideline recommendations to take these updated data into account.
