前列腺癌盆腔淋巴结清扫术：有限切除与扩大切除的随机临床试验的最新进展

IF 25.3 1区医学 Q1 UROLOGY & NEPHROLOGY

European urology Pub Date : 2024-10-29 DOI:10.1016/j.eururo.2024.10.006

Karim A. Touijer, Emily A. Vertosick, Daniel D. Sjoberg, Nicole Liso, Sunny Nalavenkata, Barbara Melao, Vincent P. Laudone, Behfar Ehdaie, Brett Carver, James A. Eastham, Peter T. Scardino, Andrew J. Vickers

{"title":"前列腺癌盆腔淋巴结清扫术：有限切除与扩大切除的随机临床试验的最新进展","authors":"Karim A. Touijer, Emily A. Vertosick, Daniel D. Sjoberg, Nicole Liso, Sunny Nalavenkata, Barbara Melao, Vincent P. Laudone, Behfar Ehdaie, Brett Carver, James A. Eastham, Peter T. Scardino, Andrew J. Vickers","doi":"10.1016/j.eururo.2024.10.006","DOIUrl":null,"url":null,"abstract":"<h3>Background and objective</h3>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.<h3>Methods</h3>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.<h3>Key findings and limitations</h3>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; <em>p</em> = 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; <em>p</em> = 0.003; distant metastasis: HR 0.75, 95% CI 0.64–0.88; <em>p</em> < 0.001).<h3>Conclusions and clinical implications</h3>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.","PeriodicalId":12223,"journal":{"name":"European urology","volume":"15 1","pages":""},"PeriodicalIF":25.3000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Pelvic Lymph Node Dissection in Prostate Cancer: Update from a Randomized Clinical Trial of Limited Versus Extended Dissection\",\"authors\":\"Karim A. Touijer, Emily A. Vertosick, Daniel D. Sjoberg, Nicole Liso, Sunny Nalavenkata, Barbara Melao, Vincent P. Laudone, Behfar Ehdaie, Brett Carver, James A. Eastham, Peter T. Scardino, Andrew J. Vickers\",\"doi\":\"10.1016/j.eururo.2024.10.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3>Background and objective</h3>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.<h3>Methods</h3>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.<h3>Key findings and limitations</h3>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; <em>p</em> = 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; <em>p</em> = 0.003; distant metastasis: HR 0.75, 95% CI 0.64–0.88; <em>p</em> < 0.001).<h3>Conclusions and clinical implications</h3>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.\",\"PeriodicalId\":12223,\"journal\":{\"name\":\"European urology\",\"volume\":\"15 1\",\"pages\":\"\"},\"PeriodicalIF\":25.3000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eururo.2024.10.006\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eururo.2024.10.006","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景和目的一个多世纪以来，淋巴结清扫术（LND）一直是癌症手术的标准术式，但很少有随机试验的证据显示LND有益处。我们进行了一项临床综合随机试验，比较了根治性前列腺切除术中的局限性盆腔淋巴结清扫术（PLND）和扩展性盆腔淋巴结清扫术（PLND），之前报告的生化复发率（BCR）具有可比性。我们报告了最新的 BCR 率，并比较了研究臂之间的转移率。方法2011 年 10 月至 2017 年 3 月间，1432 名接受根治性前列腺切除术的患者在一个中心登记入组。外科医生分组随机进行有限（髂外结节）或扩展 PLND（髂外、闭孔和胃下结节），交叉进行 3 个月的治疗。主要发现和局限性在中位随访4.2年期间，未发生BCR的参与者共发生了452例BCR事件。结果证实了我们之前的发现，即两组患者的 BCR 发生率相当（危险比 [HR] 1.05，95% 置信区间 [CI] 0.97-1.13；P = 0.3）。然而，在 123 例转移事件中，无转移患者的中位随访时间为 5.4 年，我们发现延长 PLND 对转移有临床和统计学上显著的保护作用（任何转移：HR为0.82，95% CI为0.71-0.93；P = 0.003；远处转移：结论和临床意义接受根治性前列腺切除术的患者应接受包括髂外、钝结节和胃下结节在内的扩展PLND。进一步的研究应探讨受影响结节解剖位置的生物学机制。针对其他癌症的LND试验是有必要的，并应考虑我们的临床综合设计。本试验在ClinicalTrials.gov上注册为NCT01407263。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Pelvic Lymph Node Dissection in Prostate Cancer: Update from a Randomized Clinical Trial of Limited Versus Extended Dissection

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.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

European urology 医学-泌尿学与肾脏学

CiteScore

43.00

自引率

2.60%

发文量

1753

审稿时长

23 days

期刊介绍： European Urology is a peer-reviewed journal that publishes original articles and reviews on a broad spectrum of urological issues. Covering topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, the journal also highlights recent advances in techniques, instrumentation, surgery, and pediatric urology. This comprehensive approach provides readers with an in-depth guide to international developments in urology.