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超声引导不可逆电穿孔靶向消融索引肿瘤(TARGET 研究):前瞻性开发研究评估安全性、患者报告结局和肿瘤疗效。

Targeted Ablation Using Ultrasound-Guided Irreversible Electroporation of Index Tumors (TARGET Study): Prospective Development Study Evaluating Safety, Patient-Reported Outcomes, and Oncologic Efficacy.

机构信息

Memorial Sloan Kettering Cancer Center, Department of Surgery, Urology Division, New York, New York.

Medical College of Wisconsin, Department of Urology, Milwaukee, Wisconsin.

出版信息

Urol Pract. 2024 Nov;11(6):983-990. doi: 10.1097/UPJ.0000000000000666. Epub 2024 Jul 17.

DOI:10.1097/UPJ.0000000000000666
PMID:39196716
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11507127/
Abstract

INTRODUCTION

We studied patient-reported functional outcomes, safety, and oncologic efficacy of focal irreversible electroporation as a primary treatment for intermediate-risk prostate cancer.

METHODS

Between February 2015 and April 2017, 20 consecutive patients elected irreversible electroporation and underwent 22 treatments. All underwent MRI-targeted and systematic transrectal biopsies. Eligibility criteria were grade group 2/3 prostate cancer in a maximum of 2 adjacent sextant prostate sectors in 1 hemigland without extraprostatic extension on MRI. Ablation was performed with a 5-mm cancer margin. Any grade group 1 cancer outside mapped index lesion was untreated. Outcome measures were based on the Prostate Quality of Life Survey, Male Sexual Health Questionnaire, and MRI-targeted and systematic biopsies at 3 and 12 months.

RESULTS

Nineteen patients completed irreversible electroporation. One had electrocardiographic changes, and irreversible electroporation was aborted. No deterioration was detected in urinary or sexual domains (-0.2, 95% CI -1.4, 0.9, = .7, and -1.9, 95% CI -10.1, 6.4, = .6, respectively) or health-related quality of life (-0.2, 95% CI -1.4, 1.0, = .7) at 6 months post ablation. Ejaculation volume decreased at 12 months (-1.5 points, 95% CI -2.4, -0.5, = .003). At 12 months of follow-up, 14/19 patients (74%, 95% CI 49%, 91%) had no clinically significant cancer anywhere in the prostate. Radical treatment-free survival was 79% at 2 years (95% CI 53%, 92%) and 73% at 4 years (95% CI 47%, 88%).

CONCLUSIONS

Our data show promising oncologic and functional outcomes following focal irreversible electroporation treatment for carefully selected patients with intermediate-risk prostate cancer. Further research should compare irreversible electroporation with active surveillance.

摘要

简介

我们研究了局灶性不可逆电穿孔作为中危前列腺癌的主要治疗方法的患者报告的功能结果、安全性和肿瘤疗效。

方法

在 2015 年 2 月至 2017 年 4 月期间,20 名连续患者选择不可逆电穿孔并接受了 22 次治疗。所有患者均接受 MRI 靶向和系统经直肠活检。入选标准为在 1 个半器官中,最多 2 个相邻六分区前列腺区的 2 级/3 级前列腺癌,MRI 上无前列腺外扩展。消融采用 5mm 肿瘤边界。任何未映射指数病变的 1 级组 1 癌症均未治疗。结果测量基于前列腺生活质量调查、男性性健康问卷以及 MRI 靶向和系统活检在 3 个月和 12 个月时。

结果

19 名患者完成了不可逆电穿孔。1 名患者出现心电图改变,不可逆电穿孔被中止。在尿域或性域(-0.2,95%置信区间-1.4,0.9,=0.7 和-1.9,95%置信区间-10.1,6.4,=0.6)或健康相关生活质量(-0.2,95%置信区间-1.4,1.0,=0.7)在消融后 6 个月均未检测到恶化。在 12 个月时,射精量减少(-1.5 点,95%置信区间-2.4,-0.5,=0.003)。在 12 个月的随访中,19 名患者中有 14 名(74%,95%置信区间 49%,91%)在前列腺的任何部位均无临床显著的癌症。2 年时无根治性治疗的生存率为 79%(95%置信区间 53%,92%),4 年时为 73%(95%置信区间 47%,88%)。

结论

我们的数据显示,对于精心挑选的中危前列腺癌患者,局灶性不可逆电穿孔治疗具有有前景的肿瘤学和功能学结果。进一步的研究应比较不可逆电穿孔与主动监测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/88b082a4bb6e/nihms-2003341-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/dda0704013f8/nihms-2003341-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/ab23f514e121/nihms-2003341-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/2dc9303e87d2/nihms-2003341-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/88b082a4bb6e/nihms-2003341-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/dda0704013f8/nihms-2003341-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/ab23f514e121/nihms-2003341-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/2dc9303e87d2/nihms-2003341-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74d8/11507127/88b082a4bb6e/nihms-2003341-f0004.jpg

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