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微创根治性前列腺切除术的学习曲线:肿瘤学结局的综合评估与累积求和分析

Learning curve of minimally invasive radical prostatectomy: Comprehensive evaluation and cumulative summation analysis of oncological outcomes.

作者信息

Sivaraman Arjun, Sanchez-Salas Rafael, Prapotnich Dominique, Yu Kaixin, Olivier Fabien, Secin Fernando P, Barret Eric, Galiano Marc, Rozet François, Cathelineau Xavier

机构信息

Department of Urology, Institut Mutualiste Montsouris, Paris, France.

Department of Urology, Institut Mutualiste Montsouris, Paris, France.

出版信息

Urol Oncol. 2017 Apr;35(4):149.e1-149.e6. doi: 10.1016/j.urolonc.2016.10.015. Epub 2017 Jan 20.

Abstract

BACKGROUND AND OBJECTIVE

The primary objective was to evaluate the learning curve of minimally invasive radical prostatectomy (MIRP) in our institution and analyze the salient learning curve transition points regarding oncological outcomes.

METHODS

Clinical, pathologic, and oncological outcome data were collected from our prospectively collected MIRP database to estimate positive surgical margin (PSM) and biochemical recurrence (BCR) trends during a 15-year period from 1998 to 2013. All the radical prostatectomies (laparoscopic prostatectomy [LRP]/robot-assisted laparoscopic radical prostatectomy [RARP]) were performed by 9 surgeons. PSM was defined as presence of cancer cells at inked margins. BCR was defined as serum prostate-specific antigen >0.2ng/ml and rising or start of secondary therapy. Surgical learning curve was assessed with the application of Kaplan-Meier curves, Cox regression model, cumulative summation, and logistic model to define the "transition point" of surgical improvement.

RESULTS

We identified 5,547 patients with localized prostate cancer treated with MIRP (3,846 LRP and 1,701 RARP). Patient characteristics of LRP and RARP were similar. The overall risk of PSM in LRP was 25%, 20%, and 17% for the first 50, 50 to 350, and>350 cases, respectively. For the same population, the 5-year BCR rate decreased from 30% to 16.7%. RARP started 3 years after the LRP program (after approximately 250 LRP). The PSM rate for RARP decreased from 21.8% to 20.4% and the corresponding 5-year BCR rate decreased from 17.6% to 7.9%. The cumulative summation analysis showed significantly lower PSM and BCR at 2 years occurred at the transition point of 350 cases for LRP and 100 cases for RARP. In multivariable analysis, predictors of BCR were prostate-specific antigen, Gleason score, extraprostatic disease, seminal vesicle invasion, and number of operations (P<0.05). Patients harboring PSM showed higher BCR risk (23% vs. 8%, P< 0.05).

CONCLUSIONS

Learning curve trends in our large, single-center experience show correlation between surgical experience and oncological outcomes in MIRP. Significant reduction in PSM and BCR risk at 2 years is noted after the initial 350 cases and 100 cases of LRP and RARP, respectively.

摘要

背景与目的

主要目的是评估我院微创根治性前列腺切除术(MIRP)的学习曲线,并分析与肿瘤学结局相关的显著学习曲线转折点。

方法

从我们前瞻性收集的MIRP数据库中收集临床、病理和肿瘤学结局数据,以估计1998年至2013年15年间的手术切缘阳性(PSM)和生化复发(BCR)趋势。所有根治性前列腺切除术(腹腔镜前列腺切除术[LRP]/机器人辅助腹腔镜根治性前列腺切除术[RARP])均由9名外科医生完成。PSM定义为墨染切缘存在癌细胞。BCR定义为血清前列腺特异性抗原>0.2ng/ml且持续升高或开始二次治疗。应用Kaplan-Meier曲线、Cox回归模型、累积求和法和逻辑模型评估手术学习曲线,以确定手术改善的“转折点”。

结果

我们确定了5547例接受MIRP治疗的局限性前列腺癌患者(3846例LRP和1701例RARP)。LRP和RARP患者的特征相似。LRP中,最初50例、50至350例和>350例的PSM总体风险分别为25%、20%和17%。对于同一人群,5年BCR率从30%降至16.7%。RARP在LRP项目开展3年后开始(约250例LRP之后)。RARP的PSM率从21.8%降至20.4%,相应的5年BCR率从17.6%降至7.9%。累积求和分析显示,LRP在350例、RARP在100例的转折点时,2年时的PSM和BCR显著降低。在多变量分析中,BCR的预测因素包括前列腺特异性抗原、Gleason评分、前列腺外疾病、精囊侵犯和手术例数(P<0.05)。有PSM的患者显示出更高的BCR风险(23%对8%,P<0.05)。

结论

我们大型单中心经验中的学习曲线趋势表明,MIRP中手术经验与肿瘤学结局之间存在相关性。在最初分别完成350例LRP和100例RARP后,2年时PSM和BCR风险显著降低。

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