Department of Urology, MD Anderson Cancer Center, The University of Texas, Houston, TX, USA.
Department of Urology, The Louisiana State University (LSU), LSU Health Shreveport, Shreveport, LA, USA.
BJU Int. 2018 Jul;122(1):66-75. doi: 10.1111/bju.14164. Epub 2018 Mar 25.
To evaluate the perioperative, pathological, and oncological outcomes from surgeon-led pathological staging of pelvic lymph node (LN) metastases at the time of robot-assisted radical prostatectomy (RARP).
Over the 6-year period of 2006-2012, three distinct pelvic LN dissection (PLND) strategies were used in chronological order at a single cancer referral hospital. Strategies were characterised by both an omission of PLND (pNx) vs inclusion decision threshold, and standard vs extended templates for patients selected for PLND. The three cohorts included: (i) omission vs standard template (04/2006-10/2007), for dominant Gleason score 4-5 or a prostate-specific antigen (PSA) level of >10 ng/mL; (ii) omission/standard vs extended template (11/2007-12/2010), for dominant Gleason score 4-5, PSA level of >10 ng/mL, any single core >7 mm, or >3 ipsilateral positive cores; and (iii) extended template with minimal exceptions (01/2011-08/2012). Standard outcomes data compared included: Clavien-Dindo complication rates, LN metrics (yield, percentage positive), and biochemical recurrence (BCR). A novel metric comprised 'pNx regret': the rate of pNx patients upgraded/upstaged. Exploratory analyses included selection criteria for reduced PLND templates, i.e. low-yield subsets.
Standard PLND yielded 8-10 LNs and a positive-LN yield of 2.2-6.2%. The addition of an extended PLND (E-PLND) significantly increased the yield to 14-20 LNs and the positive-LN yield to 17.4-18.4% (both P < 0.001). E-PLND had the highest impact on the percentage of positive LNs (%pN1) for high-risk disease (9.3 vs 32.8%, P = 0.002), modest for intermediate risk (4.2 vs 10.9%, P = 0.003), and minimal impact on low risk disease (4.1 vs 0%, P = 0.401). The combined strategies of setting a very low threshold for E-PLND and sending separate LN packets increased the LN yields (18 vs 24, P < 0.001), but did not significantly change the observed %pN1 rates by clinical risk group (P = 0.975). Efforts to reduce the need for E-PLND included omission by clinical criteria, but resulting in 'pNx regret' in 16-19%. A third of patients with unilateral disease and positive LNs were found to have contralateral disease. A subset of men with minimal biopsy volume Gleason score 4 + 3 had pN1 rates after E-PLND of three of 14 (21%) compared to minimal biopsy volume Gleason score 3 + 4 pN1 rates after E-PLND of 0 of 31. E-PLND takes about twice as long to perform but with no statistically significant difference in complications (5.0 vs 6.0%, P = 0.511). The 5-year BCR rates were higher for E-PLND, given the selection criteria, but not different for overall survival.
The net benefit of E-PLND remains uncertain, and therapeutic impact will probably require a randomised trial, given the strong selection criteria. E-PLND contributes to oncological staging in a significant number of high- and intermediate-risk patients, and should be bilateral. Immediate concerns include longer operative times, but no higher complication rates.
评估在机器人辅助根治性前列腺切除术(RARP)时由外科医生主导的盆腔淋巴结(LN)转移的围手术期、病理和肿瘤学结果。
在 2006 年至 2012 年的 6 年期间,在一家癌症转诊医院按时间顺序使用了三种不同的盆腔 LN 解剖(PLND)策略。这些策略的特点是在决定是否进行 PLND 时,既可以选择包括或排除标准(pNx),也可以选择标准或扩展模板。三个队列包括:(i)排除标准 vs 标准模板(04/2006-10/2007),适用于主要 Gleason 评分 4-5 或前列腺特异性抗原(PSA)水平>10ng/mL;(ii)排除/标准 vs 扩展模板(11/2007-12/2010),适用于主要 Gleason 评分 4-5、PSA 水平>10ng/mL、任何单个核心>7mm 或>3 个同侧阳性核心;(iii)最小例外的扩展模板(01/2011-08/2012)。比较的标准结果数据包括:Clavien-Dindo 并发症率、LN 指标(产量、阳性百分比)和生化复发(BCR)。一个新的指标包括“pNx 遗憾”:pNx 患者升级/升级的比例。探索性分析包括用于减少 PLND 模板的选择标准,即低产量亚组。
标准 PLND 获得 8-10 个 LN,阳性-LN 产量为 2.2-6.2%。增加扩展 PLND(E-PLND)可显著增加产量至 14-20 个 LN,阳性-LN 产量增加至 17.4-18.4%(均 P<0.001)。E-PLND 对高危疾病的阳性 LN 百分比(%pN1)的影响最大(9.3%对 32.8%,P=0.002),对中危疾病的影响适度(4.2%对 10.9%,P=0.003),对低危疾病的影响最小(4.1%对 0%,P=0.401)。设定非常低的 E-PLND 阈值并发送单独的 LN 包的综合策略增加了 LN 产量(18 对 24,P<0.001),但通过临床风险组,观察到的%pN1 率没有显著变化(P=0.975)。减少 E-PLND 需求的努力包括根据临床标准进行排除,但在 16-19%的患者中导致“pNx 遗憾”。三分之一单侧疾病和阳性 LN 的患者被发现对侧有疾病。在 E-PLND 后,最小活检体积 Gleason 评分 4+3 的患者中有 3 例(21%)出现 pN1,而 E-PLND 后最小活检体积 Gleason 评分 3+4 的患者中 pN1 发生率为 0 例(31%)。E-PLND 大约需要两倍的时间来进行,但并发症(5.0%对 6.0%,P=0.511)没有统计学显著差异。考虑到选择标准,E-PLND 的 5 年 BCR 率更高,但总体生存率没有差异。
E-PLND 的净效益仍不确定,鉴于强烈的选择标准,其治疗效果可能需要随机试验。E-PLND 对大量高危和中危患者的肿瘤分期有重要作用,应该是双侧的。目前的关注包括手术时间较长,但并发症发生率没有增加。