研究动态
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前列腺切除术床位图像引导的剂量递增性挽救放射治疗(SPIDER):国际多中心回顾性研究。

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

发表日期:2023 Apr 12
作者: Nicolas Benziane-Ouaritini, Thomas Zilli, Antoine Giraud, Gianluca Ingrosso, Mario Di Staso, Fabio Trippa, Pascal Pommier, Emmanuel Meyer, Giulio Francolini, Ulrike Schick, David Pasquier, Jean Marc Cosset, Nicolas Magne, Etienne Martin, Kémara Gnep, Raphaelle Renard-Penna, Ewen Anger, Vérane Achard, Nicolas Giraud, Cynthia Aristei, Victoria Ferrari, Corentin Pasquier, Hind Zaine, Osman Osman, Beatrice Detti, Tanguy Perennec, Inga Mihoci, Stéphane Supiot, Igor Latorzeff, Paul Sargos
来源: EUROPEAN UROLOGY ONCOLOGY

摘要:

前列腺根治术后宏观局部复发(MLR)的治疗是一项具有挑战性的情况,不存在标准化的方法。我们的研究目的是评估功能影像引导的挽救性放疗(SRT)在前列腺床MLR患者中的疗效和安全性。在这个跨16个欧洲中心的国际多中心回顾性研究中,符合条件的患者最初接受了前列腺根治术(RP),用于治疗前列腺腺癌的局部或局部晚期腺癌,可选进行盆腔淋巴结清扫或不进行。术后4周检查前列腺特异性抗原(PSA)<0.1 ng/ml。所有患者均出现了生化复发,其定义是在两次测量中PSA水平增加≥0.2 ng/ml。只有在功能成像(多参数磁共振成像、正电子发射断层显像/计算机断层扫描[ PET / CT ]胆碱或PET / CT前列腺特异性膜抗原)可见的前列腺切除术床位MLR病变的患者有资格参加研究。在重新分期影像(CT和/或骨扫描和/或磁共振成像和/或PET)中,有淋巴结、骨或内脏转移的患者被排除在外。剂量升级的定义是在MLR床位或MLR处处方剂量>66 Gy。毒性使用不良事件终末点评分表第4.03版分类。主要终末点评价进展生存期(PFS)。次要结局是无转移生存期(MPFS)、生化进展生存期和总生存期。对生殖泌尿系统(GU)和胃肠道(GI)毒性进行了分析。2000年1月至2019年12月期间,310名患者至少接受了一次MLR剂量升级,而25名患者没有接受任何剂量升级。SRT前的中位PSA水平为0.63 ng/ml(四分位距[IQR],0.27-1.7)。中位随访时间为54个月(IQR,50-56)。5年的PFS和MPFS分别为70%(95%置信区间[CI]:[64;75])和84%(95% CI:[78;88])。43例(12%)患者出现≥2级的GU和11例(3%)患者出现≥2级的GI迟发性毒性。当MLR病变处方剂量≥72 Gy时,接受至少一次剂量升级的患者5年PFS的改善发现(73% [95% CI:65-79] vs。[95% CI:48;70]; p = 0.03)。在这个集成功能成像数据的当代研究中,我们发现对于前列腺床MLR患者,在接受剂量升级≥72 Gy的情况下,SRT具有潜在的疗效和可接受的毒性。期望探索这种MLR剂量升级策略的前瞻性数据。本报告研究了在欧洲大规模人群中挽救性放疗用于前列腺癌和宏观复发的结果。我们发现,前列腺特异性抗原复发、格里森分数和剂量升级的结果不同。我们发现挽救性放疗在前列腺床宏观复发的剂量升级的潜在疗效,具有可接受的毒性剖面。版权所有©2023年欧洲泌尿科协会。由爱思唯尔出版有限公司出版。保留所有权利。
Management of macroscopic local recurrence (MLR) after radical prostatectomy is a challenging situation with no standardized approach.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.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.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.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).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.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.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.