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聚焦不可逆电穿孔作为局限性前列腺癌初始治疗后的肿瘤学和生活质量结局：一项经活检监测的前瞻性队列研究。

Oncological and Quality-of-life Outcomes Following Focal Irreversible Electroporation as Primary Treatment for Localised Prostate Cancer: A Biopsy-monitored Prospective Cohort.

机构信息

St. Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia; Garvan Institute of Medical Research and Kinghorn Cancer Centre, Darlinghurst, NSW, Australia; St Vincent's Clinical School, UNSW, Sydney, Australia.

St. Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia; Garvan Institute of Medical Research and Kinghorn Cancer Centre, Darlinghurst, NSW, Australia; Amsterdam UMC, Amsterdam, The Netherlands.

出版信息

Eur Urol Oncol. 2020 Jun;3(3):283-290. doi: 10.1016/j.euo.2019.04.008. Epub 2019 May 16.

DOI:10.1016/j.euo.2019.04.008

PMID:31103721

Abstract

BACKGROUND

Focal irreversible electroporation (IRE) can be used to treat men with localised prostate cancer (PCa) with reduced impact on quality of life (QoL).

OBJECTIVE

To assess oncological and functional outcomes.

DESIGN, SETTING, AND PARTICIPANTS: To report on a prospective database of patients undergoing primary IRE between February 2013 and August 2018. A minimum of 12-mo follow-up was available for 123 patients. Median follow-up was 36 mo (interquartile range [IQR] 24-52 mo). A total of 112 (91%) patients had National Comprehensive Cancer Network intermediate risk and 11 (9%) had low risk. A total of 12 (9.8%) had International Society of Urological Pathology (ISUP) grade 1, 88 (71.5%) had ISUP 2, and 23 (18.7%) had ISUP 3.

INTERVENTION

Focal IRE ablation of PCa lesions.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Follow-up involved serial prostate-specific antigen (PSA), multiparametric magnetic resonance imaging (mpMRI), and transperineal template mapping biopsy (TTMB) at 12 mo. Failure-free survival (FFS) was defined as progression to whole-gland or systemic treatment or metastasis/death. Functional outcomes were assessed.

RESULTS AND LIMITATIONS

Median age was 68yr (IQR 62-73yr). Median preoperative PSA was 5.7ng/ml (IQR 3.8-8.0ng/ml). On post-treatment TTMB, in-field recurrence was present in 2.7-9.8% of patients. FFS at 3yr was 96.75%, metastasis-free survival 99%, and overall survival 100%. A total of 18 patients required salvage treatment (12 had repeat IRE; six had whole-gland treatment). The negative predictive value of mpMRI was 94% and sensitivity 40% for detecting in-field residual disease 6 mo after treatment. Among patients who returned questionnaires, 80/81 (98.8%) remained pad free and 40/53 (76%) had no change in erectile function.

CONCLUSIONS

Focal IRE in select patients with localised clinically significant PCa has satisfactory short-term oncological outcomes with a minimal impact on patient QoL.

PATIENT SUMMARY

In this study, 123 patients underwent focal therapy using irreversible electroporation. Follow-up biopsy was clear of residual disease in 90.2-97.3% of patients. Of patients, 96.75% avoided whole gland treatment at 3yr.

摘要

背景

局灶性不可逆电穿孔（IRE）可用于治疗局部前列腺癌（PCa）患者，对生活质量（QoL）的影响较小。

目的

评估肿瘤学和功能学结果。

设计、设置和参与者：报告了 2013 年 2 月至 2018 年 8 月期间接受原发性 IRE 治疗的患者的前瞻性数据库。123 例患者中有 123 例获得至少 12 个月的随访。中位随访时间为 36 个月（四分位距 [IQR] 24-52 个月）。112 例（91%）患者具有国家综合癌症网络中间风险，11 例（9%）患者具有低风险。12 例（9.8%）患者的国际泌尿病理学会（ISUP）分级为 1 级，88 例（71.5%）为 ISUP 2 级，23 例（18.7%）为 ISUP 3 级。

干预

局灶性 IRE 消融前列腺癌病变。

随访措施和统计分析

随访包括在 12 个月时进行前列腺特异性抗原（PSA）、多参数磁共振成像（mpMRI）和经会阴模板定位活检（TTMB）。无进展生存（FFS）定义为向全腺或全身治疗或转移/死亡进展。评估功能结果。

结果和局限性

中位年龄为 68 岁（IQR 62-73 岁）。术前中位 PSA 为 5.7ng/ml（IQR 3.8-8.0ng/ml）。在治疗后的 TTMB 中，2.7-9.8%的患者出现了场内复发。3 年时 FFS 为 96.75%，无转移生存 99%，总生存 100%。18 例患者需要挽救性治疗（12 例接受重复 IRE；6 例接受全腺治疗）。mpMRI 的阴性预测值为 94%，治疗后 6 个月检测到场内残留疾病的敏感性为 40%。在返回问卷的患者中，80/81 例（98.8%）仍无需使用尿垫，40/53 例（76%）的勃起功能无变化。