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机器人根治性前列腺切除术在长期学习曲线后可实现优越的生化复发和长期生活质量结局——2206 例连续病例的前瞻性单外科医生队列的更新分析。

Superior Biochemical Recurrence and Long-term Quality-of-life Outcomes Are Achievable with Robotic Radical Prostatectomy After a Long Learning Curve-Updated Analysis of a Prospective Single-surgeon Cohort of 2206 Consecutive Cases.

机构信息

St Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia; Garvan Institute of Medical Research & The Kinghorn Cancer Centre, Darlinghurst, NSW, Australia; The University of New South Wales, Kensington, NSW, Australia.

Cancer Council NSW, Woolloomooloo, NSW, Australia.

出版信息

Eur Urol. 2018 May;73(5):664-671. doi: 10.1016/j.eururo.2017.11.035. Epub 2017 Dec 19.

Abstract

BACKGROUND

Our earlier analysis suggested that robot-assisted radical prostatectomy (RARP) achieved superiority over open radical prostatectomy (ORP) in terms of positive surgical margin (PSM) rates and functional outcomes.

OBJECTIVE

With larger sample size and longer follow-up, the objective of this study update is to assess whether our previous findings are upheld and whether the improved PSM rates for RARP after an initial learning curve compared with ORP-as observed in our earlier analysis-ultimately resulted in improved biochemical control.

DESIGN, SETTING, AND PARTICIPANTS: Prospective observational study comparing two surgical techniques; 2271 consecutive men underwent RARP (1520) or ORP (751) at a single centre from 2006 to 2016.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Demographic and clinicopathological data were prospectively collected. The EPIC-QOL questionnaire was administered at baseline and 1.5, 3, 6, 12, and 24 mo. Multivariate linear regression modelled the difference in quality of life (QOL) domains against case number; logistic and Cox regression modelled the differences in PSM and biochemical recurrence (BCR) hazard ratios (HR), respectively.

RESULTS AND LIMITATIONS

A total of 2206 men were included in BCR/PSM analysis and 1045 consented for QOL analysis. Superior pT2 surgical margins, early and late sexual outcomes, and early urinary outcomes were upheld and became more robust (narrowing of 95% confidence intervals [CIs]). The risk of BCR was initially higher for RARP, improved after 191 RARPs, and was 35% lower (hazard ratio [HR] 0.65, 95% CI 0.47-0.90) at final RARP, plateauing after 226 RARPs. Improved late (12-24 mo) urinary bother scores (adjusted mean difference [AMD]=4.7, 95% CI 1.3-8.0) and irritative-obstructive scores (AMD=3.8, 95% CI 0.9-5.6) at final RARP were demonstrated. Limitations include observational single surgeon data, possible residual confounding, and short follow-up.

CONCLUSIONS

The results from this updated analysis demonstrate that RARP can be beneficial for patients of high-volume surgeons, although more randomised studies and studies with survival outcomes are needed.

PATIENT SUMMARY

Robot-assisted radical prostatectomy was able to improve functional and oncological outcomes in this single surgeon's learning curve.

摘要

背景

我们之前的分析表明,机器人辅助根治性前列腺切除术(RARP)在切缘阳性率(PSM)和功能结果方面优于开放根治性前列腺切除术(ORP)。

目的

本研究更新的目的是使用更大的样本量和更长的随访时间来评估我们之前的发现是否成立,以及 RARP 是否在最初的学习曲线后比 ORP (如我们之前的分析中观察到的)实现了更高的 PSM 率,最终是否实现了更好的生化控制。

设计、地点和参与者:这是一项比较两种手术技术的前瞻性观察性研究;2006 年至 2016 年,在一家单中心,2271 例连续男性患者接受了 RARP(1520 例)或 ORP(751 例)。

观察指标和统计分析

前瞻性收集人口统计学和临床病理学数据。在基线、1.5、3、6、12 和 24 个月时使用 EPIC-QOL 问卷进行评估。多变量线性回归模型用于分析生活质量(QOL)领域的差异与病例数量的关系;逻辑回归和 Cox 回归分别用于分析 PSM 和生化复发(BCR)风险比(HR)的差异。

结果和局限性

共有 2206 例男性纳入 BCR/PSM 分析,1045 例同意进行 QOL 分析。更高的 pT2 手术切缘、早期和晚期性功能结果以及早期尿控结果得到了证实,并且变得更加可靠(95%置信区间[CI]变窄)。RARP 的 BCR 风险最初较高,在完成 191 例 RARP 后得到改善,最终 RARP 的风险降低了 35%(风险比[HR]0.65,95%CI0.47-0.90),在完成 226 例 RARP 后趋于平稳。在最后一次 RARP 时,晚期(12-24 个月)尿困扰评分(校正平均差异[AMD]=4.7,95%CI1.3-8.0)和刺激性/阻塞性评分(AMD=3.8,95%CI0.9-5.6)得到改善。局限性包括观察性单外科医生数据、可能存在残余混杂因素和随访时间短。

结论

这项更新分析的结果表明,RARP 对高容量外科医生的患者可能有益,但需要更多的随机研究和生存结果研究。

患者总结

机器人辅助根治性前列腺切除术能够改善单外科医生学习曲线中的功能和肿瘤学结果。

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