Background and objective

Lymph node dissection (LND) has been standard in cancer surgery for more than a century, yet evidence from randomized trials showing a benefit is scarce. We conducted a clinically integrated randomized trial comparing limited versus extended pelvic LND (PLND) during radical prostatectomy and previously reported comparable biochemical recurrence (BCR) rates. We report updated BCR rates and compare rates of metastasis between the study arms.

Methods

Between October 2011 and March 2017, 1432 patients undergoing radical prostatectomy were enrolled at a single center. Surgeons were cluster randomized to perform limited (external iliac nodes) or extended PLND (external iliac, obturator, and hypogastric nodes) with crossover for 3-mo periods. Cox proportional-hazards regression with robust standard errors clustered by surgeon was used to assess whether the PLND template affected BCR or distant or locoregional metastasis.

Key findings and limitations

There were 452 BCR events at median follow-up of 4.2 yr for participants who did not develop BCR. The results confirm our previous finding of comparable BCR rates between the arms (hazard ratio [HR] 1.05, 95% confidence interval [CI] 0.97–1.13; p = 0.3). However, with 123 metastasis events and median follow-up of 5.4 yr for patients without metastasis, we found a clinically and statistically significant protective effect of extended PLND against metastasis (any metastasis: HR 0.82, 95% CI 0.71–0.93; p = 0.003; distant metastasis: HR 0.75, 95% CI 0.64–0.88; p < 0.001).

Conclusions and clinical implications

Patients undergoing radical prostatectomy should receive extended PLND that includes the external iliac, obturator, and hypogastric nodes. Further research should examine biological mechanisms regarding the anatomic location of affected nodes. Trials of LND for other cancers are warranted and should consider our clinically integrated design.This trial is registered on ClinicalTrials.gov as NCT01407263.

中文翻译：

---

前列腺癌盆腔淋巴结清扫术：有限与扩展清扫随机临床试验的更新

 背景和目标

一个多世纪以来，淋巴结清扫术 （LND） 一直是癌症手术的标准，但随机试验表明其益处的证据很少。我们进行了一项临床整合随机试验，比较了根治性前列腺切除术期间局限性与扩展盆腔 LND （PLND） 以及先前报告的可比生化复发 （BCR） 率。我们报告了更新的 BCR 率并比较了研究组之间的转移率。

 方法

2011 年 10 月至 2017 年 3 月期间，1432 名接受根治性前列腺切除术的患者被纳入一个中心。外科医生被整群随机分配，进行有限 （髂外淋巴结） 或扩展 PLND （髂外淋巴结、闭孔和下腹淋巴结） 交叉 3 个月。使用外科医生聚类的稳健标准误差的 Cox 比例风险回归来评估 PLND 模板是否影响 BCR 或远处或局部转移。

主要发现和局限性

对于未发生 BCR 的参与者，在中位随访 4.2 年时有 452 例 BCR 事件。结果证实了我们之前发现的两组之间可比较的 BCR 率（风险比 [HR] 1.05,95% 置信区间 [CI] 0.97-1.13;p = 0.3）。然而，对于 123 例转移事件和无转移患者的中位随访 5.4 年，我们发现延长 PLND 对转移具有临床和统计学意义的保护作用（任何转移：HR 0.82,95% CI 0.71-0.93;p = 0.003;远处转移：HR 0.75,95% CI 0.64-0.88;p < 0.001）。

结论和临床意义

接受根治性前列腺切除术的患者应接受扩展的 PLND，包括髂外淋巴结、闭孔淋巴结和下腹淋巴结。进一步的研究应检查有关受影响淋巴结解剖位置的生物学机制。LND 治疗其他癌症的试验是必要的，应考虑我们的临床综合设计。此试用版在 ClinicalTrials.gov 上注册为 NCT01407263。