Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-risk Prostate Cancer: Early Oncological Outcomes from a Randomized Phase 3 Trial.

BACKGROUND: The role of extended pelvic lymph node dissection (EPLND) in the surgical management of prostate cancer (PCa) patients remains controversial, mainly because of a lack of randomized controlled trials (RCTs). OBJECTIVE: To determine whether EPLND has better oncological outcomes than limited PLND (LPLND. DESIGN, SETTING AND PARTICIPANTS: This was a prospective, single-center phase 3 trial in patients with intermediate- or high-risk clinically localized PCa. INTERVENTION: Randomization (1:1) to LPLND (obturator nodes) or EPLND (obturator, external iliac, internal iliac, common iliac, and presacral nodes) bilaterally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was biochemical recurrence-free survival (BRFS). Secondary outcomes were metastasis-free survival (MFS), cancer-specific survival (CSS), and histopathological findings. The trial was designed to show a minimal 15% advantage in 5-yr BRFS by EPLND. RESULTS AND LIMITATIONS: In total, 300 patients were randomized from May 2012 to December 2016 (150 LPLND and 150 EPLND). The median BRFS was 61.4 mo in the LPLND group and not reached in the EPLND group (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.63-1.32; p = 0.6). Median MFS was not reached in either group (HR 0.57, 95% CI 0.17-1.8; p = 0.3). CSS data were not available because no patient died from PCa before the cutoff date. In exploratory subgroup analysis, patients with preoperative biopsy International Society of Urological Pathology (ISUP) grade groups 3-5 who were allocated to EPLND had better BRFS (HR 0.33, 95% CI 0.14-0.74, interaction p = 0.007). The short follow-up and surgeon heterogeneity are limitations to this study. CONCLUSION: This RCT confirms that EPLND provides better pathological staging, while differences in early oncological outcomes were not demonstrated. Our subgroup analysis suggests a potential BCRFS benefit in patients diagnosed with ISUP grade groups 3-5; however, these findings should be considered hypothesis-generating and further RCTs with larger cohorts and longer follow up are necessary to better define the role of EPLND during RP. PATIENT SUMMARY: In this study, we investigated early outcomes in prostate cancer patients undergoing prostatectomy according to the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce biochemical recurrence of prostate cancer in the expected range.

Robot-assisted extended pelvic lymph node dissection in prostate cancer. When and how?

OBJECTIVE: To review the literature evaluating the role of the extended pelvic lymph node dissectione PLND during robot assisted radical prostatectomy (RARP) in the management of PCa patients, as well as the preoperative clinic pathologic factors that predict lymph node metastases (LNM). The technique and current outcomes of robotic ePLND will be presented. METHODS: Medline®/Pubmed® were searched up to august 2018 to find comparative studies of different anatomic limits of pelvic lymph node dissection (PLND) during RARP, open or pure laparoscopic surgery that reported number of nodes retrieved, oncologic outcomes and complications. The search was complemented to identify studies that evaluated diagnostic images and factors that predict LNM. Overall, 44 articles were included for full text review. RESULTS: There is not an imaging technique with an acceptable performance to select patients for PLND, the decision to perform a PLND is based on clinical characteristics described on validated nomograms. Median lymph node yield at RARP range from 5 to 21 depending on the extent of PLND, positivity rate of LN as high as 37% depending on the risk stratification of patients. Robot-assisted can be carried out to any extent with lymph node yields and safety concerns comparable to the open approach. CONCLUSION: Extended pelvic lymph node dissection is recommended to be performed at the time of RARP in intermediate and high-risk patients and cannot be replaced by other modalities. A benefit in terms of oncologic outcomes remains to be established. The robot assisted approach offers shorter length of hospital stay, lower transfusion rates and comparable outcomes compared to other surgical approaches.

ARTICULO SOLO EN INGLES.OBJETIVO: Revisar la literatura que evalúa  el papel de la linfadenectomía pélvica extendida  (LPe) durante la prostatectomía radical asistida por robot  (PRAR) en el manejo de pacientes con cáncer de próstata,  así como los factores clínico-patológicos preoperatorios  que predicen las metástasis ganglionares. Presentamos la técnica de LPe y sus resultados actuales.MÉTODOS: Se realizó una búsqueda bibliográfica en Medline®/Pubmed® hasta agosto 2018 para encontrar estudios comparativos de los diferentes límites anatómicos de la linfadenectomía pélvica duranteprostatectomía radical asistida por robot, abierta olaparoscópica que comunicaran número de ganglios,resultados oncológicos y complicaciones. La búsquedafue complementada para identificar estudios que evaluaran imágenes diagnósticas y factores predictivos demetástasis ganglionares. Finalmente, se incluyeron 44artículos. RESULTADOS: No hay una técnica de imagen que tengauna resolución aceptable para seleccionar pacientespara linfadenectomía. La decisión de practicar linfadenectomíase basa en las características clínicas descritasen nomogramas validados. La mediana del númerode ganglios obtenidos oscila entre 5 y 21 dependiendode la extensión de la linfadenectomía, y la tasa de gangliospositivos es tan alta como el 37% dependiendo dela estratificación del riesgo de los pacientes. La cirugíaasistida por robot puede realizarse con cualquier extensióncon un número de ganglios obtenidos y aspectosde seguridad comparables con el abordaje abierto. CONCLUSION: Se recomienda realizar la linfadenectomíapélvica extendida en el momento de la PRAR enpacientes de riesgo intermedio y alto y no puede reemplazarsepor otras modalidades. Sigue por establecerseun beneficio en términos de resultados oncológicos. Elabordaje asistido por robot ofrece estancias hospitalariasmás cortas, menores tasas de transfusión y resultadoscomparables en comparación con otros abordajesquirúrgicos.