Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK; Edinburgh Cancer Research Centre, MRC Institute of Genetics and Molecular Medicine, Edinburgh, UK.
Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK.
Clin Oncol (R Coll Radiol). 2022 Jan;34(1):42-49. doi: 10.1016/j.clon.2021.11.009. Epub 2021 Nov 28.
To externally validate a proposed biochemical definition of cure following low dose rate (LDR) brachytherapy for prostate cancer - 4-year post-implant prostate-specific antigen (PSA) ≤0.2 ng/ml - in a UK population, and report the long-term (10- and 15-year) outcomes for patients stratified by National Comprehensive Cancer Network (NCCN) risk groups, through analysis of a large, prospectively collected, single-centre database.
All patients treated with LDR brachytherapy for prostate cancer at a single UK centre between 2001 and November 2020 (n = 1142) were eligible; 632 patients met the inclusion criteria for the analysis. The primary end point was disease-free survival (DFS), defined as freedom from clinical, radiological or PSA progression requiring androgen deprivation therapy. Four-year PSA was categorised as ≤0.2, >0.2 to ≤0.5, >0.5 to ≤1.0 and >1.0 ng/ml. Kaplan-Meier analysis to 15 years was undertaken for each group, and sensitivity and specificity of 4-year PSA as a surrogate for long-term cure were calculated. Kaplan-Meier analysis to 15 years was repeated, stratifying patients by NCCN risk groups.
The median cohort age was 63 years; the median follow-up was 9.1 years (range 3.5-18.7). In total, 248 patients were available for analysis at year 10, 46 at year 15. Sixty-four patients (10.1%) relapsed during the study period. The 10-year DFS for 4-year PSA categories ≤0.2, >0.2 to ≤0.5, >0.5 to ≤1.0 and >1.0 ng/ml (95% confidence intervals) were 97.5% (95.4-99.6), 89.0% (82.4-96.1), 81.5% (70.5-94.2) and 41.8% (29.7-58.9), respectively. The 10-year DFS results for NCCN low, favourable-intermediate and unfavourable-intermediate risk disease were 93.1% (89.6-96.7), 92.1% (87.6-96.9) and 75.9% (67.8-84.9), respectively.
Patients with 4-year PSA ≤0.2 ng/ml may be considered cured, and could be discharged to general practitioner follow-up. LDR brachytherapy is an excellent treatment option for patients with low and favourable-intermediate risk prostate cancer, but those with unfavourable-intermediate risk disease should be considered for treatment intensification strategies.
在英国人群中，对低剂量率（LDR）近距离放射治疗前列腺癌后提出的生化治愈定义进行外部验证 - 植入后 4 年前列腺特异性抗原（PSA）≤0.2ng/ml - 并报告按国家综合癌症网络（NCCN）风险组分层的患者的长期（10 年和 15 年）结果，通过对大型前瞻性收集的单中心数据库进行分析。
2001 年至 2020 年 11 月期间在英国一家单一中心接受 LDR 近距离放射治疗前列腺癌的所有患者均符合条件（n=1142）；632 名患者符合分析标准。主要终点是无病生存（DFS），定义为无临床、影像学或需要雄激素剥夺治疗的 PSA 进展。4 年 PSA 分为≤0.2、>0.2 至≤0.5、>0.5 至≤1.0 和>1.0ng/ml。对每组进行 15 年的 Kaplan-Meier 分析，并计算 4 年 PSA 作为长期治愈替代指标的敏感性和特异性。对 NCCN 风险组患者进行分层，重复 15 年的 Kaplan-Meier 分析。
队列的中位年龄为 63 岁；中位随访时间为 9.1 年（范围 3.5-18.7）。在研究期间，共有 248 名患者可在第 10 年进行分析，46 名患者在第 15 年进行分析。64 名患者（10.1%）在研究期间复发。4 年 PSA 类别≤0.2、>0.2 至≤0.5、>0.5 至≤1.0 和>1.0ng/ml（95%置信区间）的 10 年 DFS 分别为 97.5%（95.4-99.6）、89.0%（82.4-96.1）、81.5%（70.5-94.2）和 41.8%（29.7-58.9）。NCCN 低风险、有利中风险和不利中风险疾病的 10 年 DFS 结果分别为 93.1%（89.6-96.7）、92.1%（87.6-96.9）和 75.9%（67.8-84.9）。
4 年 PSA≤0.2ng/ml 的患者可被认为已治愈，并可转至全科医生随访。LDR 近距离放射治疗是低危和有利中危前列腺癌患者的极佳治疗选择，但对不利中危疾病患者应考虑强化治疗策略。
