原发性局灶性不可逆电穿孔治疗局限性前列腺癌的 5 年中位结果。

Median 5-year outcomes of primary focal irreversible electroporation for localised prostate cancer.

机构信息

Garvan Institute of Medical Research and The Kinghorn Cancer Centre, Darlinghurst, Sydney, NSW, Australia.

Department of Urology, St. Vincent's Prostate Cancer Research Centre, Darlinghurst, Sydney, NSW, Australia.

出版信息

BJU Int. 2023 Jun;131 Suppl 4:6-13. doi: 10.1111/bju.15946. Epub 2022 Dec 28.

DOI:10.1111/bju.15946

PMID:36495481

Abstract

OBJECTIVES

To evaluate longer-term oncological and functional outcomes of focal irreversible electroporation (IRE) as primary treatment for localised clinically significant prostate cancer (csPCa) at a median follow-up of 5 years (up to 10 years).

PATIENTS AND METHODS

All patients that underwent focal IRE as primary treatment for localised PCa between February 2013 and August 2021 with a minimum 12 months of follow-up were analysed. Follow-up included 6-month magnetic resonance imaging (MRI) and standardised transperineal saturation template ± targeted biopsies at 12 months, and further biopsies in the case of clinical suspicion on serial imaging and/or prostate-specific antigen (PSA) levels. Failure-free survival (FFS) was defined as no progression to radical treatment or nodal/distant disease. Local recurrence was defined as any International Society of Urological Pathology Grade of ≥2 on biopsy.

RESULTS

A total of 229 patients were analysed with a median (interquartile range [IQR]) follow-up of 60 (40-80) months. The median (IQR) age was 68 (64-74) years, the median (IQR) PSA level was 5.9 (4.1-8.2) ng/mL, and 86% harboured intermediate-risk disease and 7% high-risk disease. In all, 38 patients progressed to radical treatment (17%), at a median (IQR) of 35 (17-53) months after IRE. Kaplan-Meier FFS rates were 91% at 3 years, 84% at 5 years and 69% at 8 years. Metastasis-free survival was 99.6% (228/229), PCa-specific and overall survival were 100% (229/229). Residual csPCa was found in 24% (45/190) during follow-up biopsy and MRI showed a complete ablation in 82% (186/226). Short-term urinary continence was preserved (98%, three of 144 at baseline, 99%, one of 131 at 12 months) and erections sufficient for intercourse decreased by 13% compared to baseline (71% to 58%).

CONCLUSION

Longer-term follow-up confirms our earlier findings that focal IRE provides acceptable local and distant oncological control in selected men with less urinary and sexual toxicity than radical treatment. Long-term follow-up and external validation of these findings, is required to establish this new treatment paradigm as a valid treatment option.

摘要

目的

评估在中位随访时间为 5 年（最长达 10 年）时，对局限性临床显著前列腺癌（csPCa）进行焦点不可逆电穿孔（IRE）作为主要治疗的长期肿瘤学和功能结局。

患者和方法

分析了 2013 年 2 月至 2021 年 8 月期间因局限性前列腺癌接受焦点 IRE 作为主要治疗的所有患者，随访时间至少为 12 个月。随访包括 6 个月时的磁共振成像（MRI）和经会阴饱和模板±靶向活检 12 个月，以及在连续影像学和/或前列腺特异性抗原（PSA）水平存在临床可疑的情况下进一步进行活检。无进展生存（FFS）定义为未进展为根治性治疗或淋巴结/远处疾病。局部复发定义为活检任何国际泌尿病理学会分级≥2。

结果

共分析了 229 例患者，中位（四分位距 [IQR]）随访时间为 60（40-80）个月。中位（IQR）年龄为 68（64-74）岁，中位（IQR）PSA 水平为 5.9（4.1-8.2）ng/ml，86%为中危疾病，7%为高危疾病。共有 38 例患者进展为根治性治疗（17%），在 IRE 后中位（IQR）时间为 35（17-53）个月。Kaplan-Meier FFS 率在 3 年时为 91%，在 5 年时为 84%，在 8 年时为 69%。无转移生存为 99.6%（228/229），前列腺癌特异性和总生存为 100%（229/229）。在随访活检中发现 24%（45/190）有残留的 csPCa，MRI 显示 82%（186/226）有完全消融。短期尿控保留（98%，基线时 144 例中有 3 例，12 个月时 131 例中有 1 例），与基线相比，勃起功能足以进行性交下降了 13%（71%降至 58%）。