Garvan Institute of Medical Research and Kinghorn Cancer Centre.
St Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia.
BJU Int. 2018 May;121(5):716-724. doi: 10.1111/bju.13983. Epub 2017 Sep 4.
To determine the safety, quality of life (QoL) and short-term oncological outcomes of primary focal irreversible electroporation (IRE) for the treatment of localized prostate cancer (PCa), and to identify potential risk factors for oncological failure.
Patients who met the consensus guidelines on patient criteria and selection methods for primary focal therapy were eligible for analysis. Focal IRE was performed for organ-confined clinically significant PCa, defined as high-volume disease with Gleason sum score 6 (International Society of Urological Pathology [ISUP] grade 1) or any Gleason sum score of 7 (ISUP grades 2-3). Oncological, adverse event (AE) and QoL outcome data, with a minimum of 6 months' follow-up, were analysed. Patient characteristics and peri-operative treatment variables were compared between patients with and without oncological failure on follow-up biopsy. Wilcoxon's signed rank test, Wilcoxon's rank sum test and the chi-squared test were used to assess statistically significant differences in paired continuous, unpaired continuous and categorical variables respectively.
A total of 63 patients met all eligibility criteria and were included in the final analysis. No high-grade AEs occurred. QoL questionnaire analysis demonstrated no significant change from baseline in physical (P = 0.81), mental (P = 0.48), bowel (P = 0.25) or urinary QoL domains (P = 0.41 and P = 0.25), but there was a mild decrease in the sexual QoL domain (median score 66 at baseline vs 54 at 6 months; P < 0.001). Compared with baseline, a decline of 70% in prostate-specific antigen level (1.8 ng/mL, interquartile range 0.96-4.8 ng/mL) was seen at 6-12 months. A narrow safety margin (P = 0.047) and system errors (P = 0.010) were identified as potential early risk factors for in-field oncological failure. In-field and whole-gland oncological control on follow-up biopsies was 84% (38/45 patients) and 76% (34/45 patients); this increased to 97% (38/39 patients) and 87% (34/39 patients) when patients treated with a narrow safety margin and system errors were excluded.
Our data support the safety and feasibility of focal IRE as a primary treatment for localized PCa with effective short-term oncological control in carefully selected men.
确定原发性局灶性不可逆电穿孔（IRE）治疗局限性前列腺癌（PCa）的安全性、生活质量（QoL）和短期肿瘤学结果，并确定肿瘤学失败的潜在危险因素。
符合原发性局灶性治疗患者标准和选择方法共识指南的患者有资格进行分析。局灶性 IRE 适用于局限性临床显著的 PCa，定义为高体积疾病，Gleason 总和评分 6（国际泌尿病理学会 [ISUP] 分级 1）或任何 Gleason 总和评分 7（ISUP 分级 2-3）。对至少 6 个月随访的肿瘤学、不良事件（AE）和 QoL 结果数据进行分析。比较随访活检时肿瘤学失败和无肿瘤学失败患者的患者特征和围手术期治疗变量。Wilcoxon 符号秩检验、Wilcoxon 秩和检验和卡方检验分别用于评估配对连续、非配对连续和分类变量的统计学显著差异。
共有 63 名患者符合所有入选标准，并纳入最终分析。无高级别 AE 发生。QoL 问卷分析显示，身体（P = 0.81）、心理（P = 0.48）、肠道（P = 0.25）或尿 QoL 领域（P = 0.41 和 P = 0.25）无显著变化，但性 QoL 领域有轻度下降（基线时中位数评分 66 分，6 个月时 54 分；P < 0.001）。与基线相比，前列腺特异性抗原水平下降 70%（1.8ng/ml，四分位距 0.96-4.8ng/ml），在 6-12 个月时可见。狭窄的安全范围（P = 0.047）和系统误差（P = 0.010）被确定为场内肿瘤学失败的潜在早期危险因素。在随访活检中，场内和全腺体肿瘤学控制率分别为 84%（45 例患者中有 38 例）和 76%（45 例患者中有 34 例）；当排除安全范围狭窄和系统误差的患者时，该比例分别增加至 97%（39 例患者中有 38 例）和 87%（39 例患者中有 34 例）。
我们的数据支持局灶性 IRE 作为局限性 PCa 的主要治疗方法的安全性和可行性，在精心挑选的男性中具有有效的短期肿瘤学控制效果。
