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前列腺切除术床图像引导剂量递增挽救性放疗(SPIDER):一项国际多中心回顾性研究。

Prostatectomy Bed Image-guided Dose-escalated Salvage Radiotherapy (SPIDER): An International Multicenter Retrospective Study.

机构信息

Department of Radiotherapy, Bergonie Institute, Bordeaux, France.

Department of Radiotherapy, University of Geneva, Geneva, Switzerland.

出版信息

Eur Urol Oncol. 2023 Aug;6(4):390-398. doi: 10.1016/j.euo.2023.02.013. Epub 2023 Apr 13.

Abstract

BACKGROUND

Management of macroscopic local recurrence (MLR) after radical prostatectomy is a challenging situation with no standardized approach.

OBJECTIVE

The objective of our study was to assess the efficacy and safety of functional image-guided salvage radiotherapy (SRT) in patients with MLR in the prostate bed.

DESIGN, SETTING, AND PARTICIPANTS: In this international multicenter retrospective study across 16 European centers, eligible patients were initially treated by radical prostatectomy (RP) with or without pelvic lymph node dissection for localized or locally advanced adenocarcinoma of the prostate.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Prostate-specific antigen (PSA) measured 4 wk after RP was <0.1 ng/ml. All patients presented a biochemical relapse after RP defined by an increase in PSA level of ≥0.2 ng/ml on two successive measures. Only patients with an MLR lesion in the prostatectomy bed visualized on functional imaging (multiparametric magnetic resonance imaging, positron emission tomography/computed tomography [PET/CT] choline, or PET/CT prostate-specific membrane antigen) were eligible. Patients with lymph node, bone, or visceral dissemination at restaging imaging (CT and/or bone scintigraphy and/or magnetic resonance imaging and/or PET) were excluded. Dose escalation was defined as a dose of >66 Gy prescribed to the prostate bed or to MLR. Toxicities were classified using the Common Terminology Criteria for Adverse Events scale, version 4.03. The primary endpoint was progression-free survival (PFS). Secondary outcomes were metastasis-free survival (MPFS), biochemical progression-free survival, and overall survival. Genitourinary (GU) and gastrointestinal (GI) toxicities were analyzed.

RESULTS AND LIMITATIONS

Between January 2000 and December 2019, 310 patients received at least one dose escalation on MLR and 25 patients did not receive any dose escalation. The median PSA level before SRT was 0.63 ng/ml (interquartile range [IQR], 0.27-1.7). The median follow-up was 54 mo (IQR, 50-56). Five-year PFS and MPFS were 70% (95% confidence interval [CI]: [64; 75]) and 84% (95% CI: [78; 88]), respectively. Grade ≥2 GU and GI late toxicities were observed in 43 (12%) and 11 (3%) patients, respectively. When the prescribed dose on the MLR lesion was ≥72 Gy, an improvement in 5-yr PFS was found for patients received at least one dose escalation (73% [95% CI: 65-79]) vs 60% [95% CI: 48; 70]; p = 0.03).

CONCLUSIONS

In this contemporary study integrating functional imaging data, we found potential efficacy of SRT with dose escalation ≥72 Gy for patients with MLR in the prostate bed and with an acceptable toxicity profile. Prospective data exploring this MLR dose escalation strategy are awaited.

PATIENT SUMMARY

In this report, we looked at the outcomes from salvage radiotherapy for prostate cancer and macroscopic relapse in a large European population. We found that outcomes varied with prostate-specific antigen at relapse, Gleason score, and dose escalation. We found potential efficacy of salvage radiotherapy with dose escalation for macroscopic relapse in the prostate bed, with an acceptable toxicity profile.

摘要

背景

根治性前列腺切除术后的宏观局部复发(MLR)的管理是一个具有挑战性的情况,目前还没有标准化的方法。

目的

我们的研究目的是评估功能图像引导下挽救性放疗(SRT)在前列腺床 MLR 患者中的疗效和安全性。

设计、地点和参与者:在这项跨越 16 个欧洲中心的国际多中心回顾性研究中,合格的患者最初接受根治性前列腺切除术(RP)治疗,无论是否联合盆腔淋巴结清扫术,用于治疗局限性或局部晚期前列腺腺癌。

结局测量和统计分析

RP 后 4 周测量的前列腺特异性抗原(PSA)<0.1ng/ml。所有患者在 RP 后均出现生化复发,定义为两次连续测量 PSA 水平升高≥0.2ng/ml。只有在功能影像学(多参数磁共振成像、正电子发射断层扫描/计算机断层扫描 [PET/CT] 胆碱、或 PET/CT 前列腺特异性膜抗原)上可见前列腺切除术床 MLR 病变的患者才有资格接受治疗。在重新分期成像(CT 和/或骨扫描和/或磁共振成像和/或 PET)时排除有淋巴结、骨或内脏转移的患者。剂量递增定义为对前列腺床或 MLR 给予>66Gy 的剂量。使用通用不良事件术语标准 4.03 版对毒性进行分类。主要终点是无进展生存期(PFS)。次要结局是无转移生存期(MPFS)、生化无进展生存期和总生存期。分析了泌尿生殖系统(GU)和胃肠道(GI)毒性。

结果和局限性

2000 年 1 月至 2019 年 12 月,310 名患者在 MLR 上至少接受了一次剂量递增,25 名患者未接受任何剂量递增。SRT 前 PSA 中位数为 0.63ng/ml(四分位距 [IQR]:0.27-1.7)。中位随访时间为 54 个月(IQR:50-56)。5 年 PFS 和 MPFS 分别为 70%(95%CI:[64;75])和 84%(95%CI:[78;88])。分别有 43 名(12%)和 11 名(3%)患者出现≥2 级 GU 和 GI 晚期毒性。当 MLR 病变的规定剂量≥72Gy 时,我们发现至少接受一次剂量递增的患者 5 年 PFS 有所改善(73%[95%CI:65-79%] vs 60%[95%CI:48;70%];p=0.03)。

结论

在这项整合功能影像学数据的当代研究中,我们发现,对于前列腺床 MLR 且毒性特征可接受的患者,SRT 联合剂量递增≥72Gy 可能具有疗效。正在探索这种 MLR 剂量递增策略的前瞻性数据。

患者总结

在本报告中,我们研究了挽救性放疗在欧洲大型人群中治疗前列腺癌和 MLR 的结果。我们发现,结果随前列腺特异性抗原在复发时、Gleason 评分和剂量递增而变化。我们发现,在前列腺床 MLR 中,SRT 联合剂量递增具有潜在疗效,且具有可接受的毒性特征。

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